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This study will provide much needed information about how to optimize the quality of care and quality of life of Veterans who are survivors of prostate cancer.
Although there are nearly 150,000 prostate cancer survivors in the VA, there has been little research to understand and improve survivorship care for this large population of Veterans. A substantial proportion of prostate cancer survivors in the general population have significant side effects from treatment (surgery or radiation therapy) that often persist for years, including incontinence, erectile dysfunction, and metabolic syndrome, all of which can contribute to decreased quality of life. The investigators' pilot data suggests that VA prostate cancer survivors experience similar or worse symptom burden to that of the general population of survivors. To address the need to improve patient-centered survivorship care management for Veterans with prostate cancer, the investigators propose a 4 year study with two aims: 1) to conduct a randomized controlled trial to compare a personally tailored automated telephone symptom management intervention for improving symptoms and symptom self-management to usual care. The investigators expect that those in the intervention group will have more confidence in symptom self-management and better symptom self-management and prostate cancer quality of life following the intervention, and that these outcomes will translate to more efficient use of services for these Veterans, and 2) to compare utilization of services among those in the intervention group to those in the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVR Intervention | Experimental | The intervention will consist of two components, both with content design based on established theories for self-management support: 1) automated telephone monitoring of PC survivor symptoms and goals for symptom reduction, based on a patient empowerment approach, and 2) personally tailored newsletters that incorporate elements of CBT to improve survivors' identification with the material, confidence/self-efficacy in symptom management, and to reduce common cognitive distortions related to successful implementation of behavior change. Intervention-group participants will receive four automated assessment and self-management support calls over a 3-month period (at baseline, 1-month, 2-month, 3-months). Information collected during automated phone assessments will be used to construct tailored newsletters, which will be sent following each automated call. |
|
| Enhanced Usual Care | No Intervention | Because of the strong evidence documenting symptom burden in PC survivors, the investigators believe that providing control subjects with some information about symptom self-management is warranted. The investigators further believe, based on the investigators' prior experience conducting RCTs, that offering some type of educational material for Veterans randomized to the control arm will increase their willingness to enroll in the study (as opposed to a pure usual care arm where they would not receive any such materials). Therefore, survivors randomized to the control condition will receive written material at the time of enrollment designed to educate them about PC symptoms and symptom management. Material will be approximately six pages in length, also written at or below an 8th grade reading level, and will include a summary of common symptoms experienced by prostate cancer survivors. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive Voice Response Symptom Management | Behavioral | The Interactive Voice Response (IVR) system will provide automated telephone monitoring of PC survivor symptoms and goals for symptom reduction, based on a patient empowerment approach. |
| Measure | Description | Time Frame |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | Baseline |
| The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | Baseline |
| The Expanded Prostate Cancer Index (EPIC) - Bowel Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | Baseline |
| The Expanded Prostate Cancer Index (EPIC) - Sexual Health |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer Control | We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer control was assessed during the five- and 12-month follow-ups using two cancer control items from the instrument. Scores range from 2 to 10 and higher scores indicate higher confidence that cancer is under control. |
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Inclusion Criteria:
Exclusion Criteria:
Prostate cancer is a disease which only affects men.
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| Name | Affiliation | Role |
|---|---|---|
| Sarah T Hawley, PhD MPH BA | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States | ||
| St. Louis VA Medical Center John Cochran Division, St. Louis, MO |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28902665 | Background | Telem DA, Dimick J, Skolarus TA. Dissecting Surgeon Behavior: Leveraging the Theoretical Domains Framework to Facilitate Evidence-based Surgical Practice. Ann Surg. 2018 Mar;267(3):432-434. doi: 10.1097/SLA.0000000000002506. No abstract available. | |
| 28619632 | Background | Skolarus TA, Wittmann D, Hawley ST. Enhancing prostate cancer survivorship care through self-management. Urol Oncol. 2017 Sep;35(9):564-568. doi: 10.1016/j.urolonc.2017.05.008. Epub 2017 Jun 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IVR Intervention | The intervention will consist of two components, both with content design based on established theories for self-management support: 1) automated telephone monitoring of PC survivor symptoms and goals for symptom reduction, based on a patient empowerment approach, and 2) personally tailored newsletters that incorporate elements of CBT to improve survivors' identification with the material, confidence/self-efficacy in symptom management, and to reduce common cognitive distortions related to successful implementation of behavior change. Intervention-group participants will receive four automated assessment and self-management support calls over a 3-month period (at baseline, 1-month, 2-month, 3-months). Information collected during automated phone assessments will be used to construct tailored newsletters, which will be sent following each automated call. |
| FG001 | Enhanced Usual Care | Because of the strong evidence documenting symptom burden in PC survivors, the investigators believe that providing control subjects with some information about symptom self-management is warranted. The investigators further believe, based on the investigators' prior experience conducting RCTs, that offering some type of educational material for Veterans randomized to the control arm will increase their willingness to enroll in the study (as opposed to a pure usual care arm where they would not receive any such materials). Therefore, survivors randomized to the control condition will receive written material at the time of enrollment designed to educate them about PC symptoms and symptom management. Material will be approximately six pages in length, also written at or below an 8th grade reading level, and will include a summary of common symptoms experienced by prostate cancer survivors. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IVR Intervention | The intervention will consist of two components, both with content design based on established theories for self-management support: 1) automated telephone monitoring of PC survivor symptoms and goals for symptom reduction, based on a patient empowerment approach, and 2) personally tailored newsletters that incorporate elements of CBT to improve survivors' identification with the material, confidence/self-efficacy in symptom management, and to reduce common cognitive distortions related to successful implementation of behavior change. Intervention-group participants will receive four automated assessment and self-management support calls over a 3-month period (at baseline, 1-month, 2-month, 3-months). Information collected during automated phone assessments will be used to construct tailored newsletters, which will be sent following each automated call. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | Thirty (5.4%) enrollees did not do EPIC-26. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
Adverse event data was collected from the start of recruitment on 4/17/15 through the final 12-month assessment on 2/2/18.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IVR Intervention | The intervention will consist of two components, both with content design based on established theories for self-management support: 1) automated telephone monitoring of PC survivor symptoms and goals for symptom reduction, based on a patient empowerment approach, and 2) personally tailored newsletters that incorporate elements of CBT to improve survivors' identification with the material, confidence/self-efficacy in symptom management, and to reduce common cognitive distortions related to successful implementation of behavior change. Intervention-group participants will receive four automated assessment and self-management support calls over a 3-month period (at baseline, 1-month, 2-month, 3-months). Information collected during automated phone assessments will be used to construct tailored newsletters, which will be sent following each automated call. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip arthroplasty | Surgical and medical procedures | Non-systematic Assessment | Pt was admitted to hospital for previously scheduled left total hip arthroplasty |
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Veterans without telephones or the ability to use automated telephone systems could not enroll.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Hawley | Department of Veterans Affairs | 734-936-8816 | sarahawl@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2017 | Nov 28, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Tailored Newsletters | Behavioral | Personally tailored newsletters will incorporate elements of CBT to improve survivors' identification with the material, confidence/self-efficacy in symptom management, and to reduce common cognitive distortions related to successful implementation of behavior change. Information collected during automated phone assessments will be used to construct tailored newsletters, which will be sent following each automated call. |
|
The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.
| Baseline |
| The Expanded Prostate Cancer Index (EPIC) - General Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | Baseline |
| The Expanded Prostate Cancer Index (EPIC) - EPIC-26 Mean | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. The EPIC-26 mean is the average of the five EPIC subscales. | Baseline |
| The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | 5 Months |
| The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | 5 Months |
| The Expanded Prostate Cancer Index (EPIC) - Bowel Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | 5 Months |
| The Expanded Prostate Cancer Index (EPIC) - Sexual Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | 5 Months |
| The Expanded Prostate Cancer Index (EPIC) - General Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | 5 Months |
| The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | 12 Months |
| The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | 12 Months |
| The Expanded Prostate Cancer Index (EPIC) - Bowel Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | 12 Months |
| The Expanded Prostate Cancer Index (EPIC) - Sexual Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | 12 Months |
| The Expanded Prostate Cancer Index (EPIC) - General Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | 12 Months |
| Confidence in Symptom Self-Management | Confidence in symptom self-management was measured using a 5-item scale developed from our pilot work. Scores range from 5 to 15 with higher scores indicating higher level of confidence. | 5 months |
| Confidence in Symptom Self-Management | Confidence in symptom self-management was measured using a 5-item scale developed from our pilot work. Scores range from 5 to 15 with higher scores indicating higher level of confidence. | 12 months |
| 5 months |
| Cancer Control | We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer control was assessed during the five- and 12-month follow-ups using two cancer control items from the instrument. Scores range from 2 to 10 and higher scores indicate higher confidence that cancer is under control. | 12 months |
| Cancer Outlook | We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer outlook was assessed during the five- and 12-month follow-ups using three cancer outlook items from the instrument. Scores range from 3 to 15 and higher scores indicate more positive cancer outlook. | 5 months |
| Cancer Outlook | We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer outlook was assessed during the five- and 12-month follow-ups using three cancer outlook items from the instrument. Scores range from 3 to 15 and higher scores indicate more positive cancer outlook. | 12 months |
| Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form | Self-efficacy in patient-physician interactions was assessed at 5 and 12 months using a five-item short form version of the Perceived Efficacy in Patient-Physician Interactions (PEPPI). The PEPPI was developed to measure older patients' self-efficacy in obtaining medical information and attention to their medical concerns from physicians. Scores range from 0-25 with higher scores indicating higher self-efficacy. | 5 months |
| Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form | Self-efficacy in patient-physician interactions was assessed at 5 and 12 months using a five-item short form version of the Perceived Efficacy in Patient-Physician Interactions (PEPPI). The PEPPI was developed to measure older patients' self-efficacy in obtaining medical information and attention to their medical concerns from physicians. Scores range from 0-25 with higher scores indicating higher self-efficacy. | 12 months |
| Brief Cope - 6 Items | We assessed participants' coping during the five- and 12-month follow-up assessments using six items from the 28-item Brief Cope instrument. This instrument measures emotion-focused, problem-focused, and dysfunctional coping and has been used in cancer survivors. Scores range from 1 to 5 with higher scores indicating better coping skills. | 5 months |
| Brief Cope - 6 Items | We assessed participants' coping during the five- and 12-month follow-up assessments using six items from the 28-item Brief Cope instrument. This instrument measures emotion-focused, problem-focused, and dysfunctional coping and has been used in cancer survivors. Scores range from 1 to 5 with higher scores indicating better coping skills. | 12 months |
| Veteran Quality of Life Scale (VR-12) - Physical Health, 2 Items | We assessed subjective physical health using 2 items from the VR-12 (SF-12 for veterans), an established measure of overall QOL that includes perceptions of one's health that may be impacted by prostate cancer. The scores range from 1- 3 and higher scores correspond to better health. | 12 months |
| Veteran Quality of Life Scale (VR-12) - Emotional Health, 3 Items | We assessed subjective emotional health using 3 items from the VR-12 (SF-12 for veterans), an established measure of overall QOL that includes perceptions of one's health that may be impacted by prostate cancer. The scores range from 1- 6 and higher scores correspond to better health. | 12 months |
| St Louis |
| Missouri |
| 63106 |
| United States |
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106 | United States |
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania | 15240 | United States |
| 28420419 | Background | Skolarus TA, Metreger T, Hwang S, Kim HM, Grubb RL 3rd, Gingrich JR, Hawley ST. Optimizing veteran-centered prostate cancer survivorship care: study protocol for a randomized controlled trial. Trials. 2017 Apr 18;18(1):181. doi: 10.1186/s13063-017-1925-4. |
| 30925126 | Result | Skolarus TA, Metreger T, Wittmann D, Hwang S, Kim HM, Grubb RL 3rd, Gingrich JR, Zhu H, Piette JD, Hawley ST. Self-Management in Long-Term Prostate Cancer Survivors: A Randomized, Controlled Trial. J Clin Oncol. 2019 May 20;37(15):1326-1335. doi: 10.1200/JCO.18.01770. Epub 2019 Mar 29. |
| BG001 | Enhanced Usual Care | Because of the strong evidence documenting symptom burden in PC survivors, the investigators believe that providing control subjects with some information about symptom self-management is warranted. The investigators further believe, based on the investigators' prior experience conducting RCTs, that offering some type of educational material for Veterans randomized to the control arm will increase their willingness to enroll in the study (as opposed to a pure usual care arm where they would not receive any such materials). Therefore, survivors randomized to the control condition will receive written material at the time of enrollment designed to educate them about PC symptoms and symptom management. Material will be approximately six pages in length, also written at or below an 8th grade reading level, and will include a summary of common symptoms experienced by prostate cancer survivors. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Enhanced Usual Care | Because of the strong evidence documenting symptom burden in PC survivors, the investigators believe that providing control subjects with some information about symptom self-management is warranted. The investigators further believe, based on the investigators' prior experience conducting RCTs, that offering some type of educational material for Veterans randomized to the control arm will increase their willingness to enroll in the study (as opposed to a pure usual care arm where they would not receive any such materials). Therefore, survivors randomized to the control condition will receive written material at the time of enrollment designed to educate them about PC symptoms and symptom management. Material will be approximately six pages in length, also written at or below an 8th grade reading level, and will include a summary of common symptoms experienced by prostate cancer survivors. |
|
|
| Primary | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | Thirty (5.4%) enrollees did not do EPIC-26, and two enrollees did only one or two subscales. EPIC-Urinary Health Obstructive was not done in 31 persons. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | The Expanded Prostate Cancer Index (EPIC) - Bowel Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | Thirty (5.4%) enrollees did not do EPIC-26, and two enrollees did only one or two subscales. EPIC-Bowel Health was not done in 32 persons. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | The Expanded Prostate Cancer Index (EPIC) - Sexual Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | Thirty (5.4%) enrollees did not do EPIC-26, and two enrollees did only one or two subscales. EPIC-Sexual Health was not done in 58 persons. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | The Expanded Prostate Cancer Index (EPIC) - General Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | Thirty (5.4%) enrollees did not do EPIC-26, and two enrollees did only one or two subscales. EPIC-General Health was not done in 32 persons. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
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| Primary | The Expanded Prostate Cancer Index (EPIC) - EPIC-26 Mean | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. The EPIC-26 mean is the average of the five EPIC subscales. | Average of 5 EPIC-26 subscales based on 524 person data (260 in control and 264 in IVR group): 30 (5.4%) enrollees did not do EPIC-26, and two enrollees did only one or two subscales. EPIC-Urinary Health Irritative was not done in 30 persons, Urinary Health Obstructive in 31, Bowel Health in 32, Sexual Health in 58 and General Health in 32 persons | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Primary | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 5 Months |
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| Primary | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 5 Months |
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| Primary | The Expanded Prostate Cancer Index (EPIC) - Bowel Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 5 Months |
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| Primary | The Expanded Prostate Cancer Index (EPIC) - Sexual Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 5 Months |
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| Primary | The Expanded Prostate Cancer Index (EPIC) - General Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 5 Months |
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| Primary | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 12 Months |
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| Primary | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 12 Months |
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| Primary | The Expanded Prostate Cancer Index (EPIC) - Bowel Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 12 Months |
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| Primary | The Expanded Prostate Cancer Index (EPIC) - Sexual Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 12 Months |
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| Primary | The Expanded Prostate Cancer Index (EPIC) - General Health | The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 12 Months |
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| Primary | Confidence in Symptom Self-Management | Confidence in symptom self-management was measured using a 5-item scale developed from our pilot work. Scores range from 5 to 15 with higher scores indicating higher level of confidence. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 5 months |
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| Primary | Confidence in Symptom Self-Management | Confidence in symptom self-management was measured using a 5-item scale developed from our pilot work. Scores range from 5 to 15 with higher scores indicating higher level of confidence. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Cancer Control | We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer control was assessed during the five- and 12-month follow-ups using two cancer control items from the instrument. Scores range from 2 to 10 and higher scores indicate higher confidence that cancer is under control. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 5 months |
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| Secondary | Cancer Control | We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer control was assessed during the five- and 12-month follow-ups using two cancer control items from the instrument. Scores range from 2 to 10 and higher scores indicate higher confidence that cancer is under control. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Cancer Outlook | We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer outlook was assessed during the five- and 12-month follow-ups using three cancer outlook items from the instrument. Scores range from 3 to 15 and higher scores indicate more positive cancer outlook. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 5 months |
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| Secondary | Cancer Outlook | We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer outlook was assessed during the five- and 12-month follow-ups using three cancer outlook items from the instrument. Scores range from 3 to 15 and higher scores indicate more positive cancer outlook. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form | Self-efficacy in patient-physician interactions was assessed at 5 and 12 months using a five-item short form version of the Perceived Efficacy in Patient-Physician Interactions (PEPPI). The PEPPI was developed to measure older patients' self-efficacy in obtaining medical information and attention to their medical concerns from physicians. Scores range from 0-25 with higher scores indicating higher self-efficacy. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 5 months |
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| Secondary | Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form | Self-efficacy in patient-physician interactions was assessed at 5 and 12 months using a five-item short form version of the Perceived Efficacy in Patient-Physician Interactions (PEPPI). The PEPPI was developed to measure older patients' self-efficacy in obtaining medical information and attention to their medical concerns from physicians. Scores range from 0-25 with higher scores indicating higher self-efficacy. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Brief Cope - 6 Items | We assessed participants' coping during the five- and 12-month follow-up assessments using six items from the 28-item Brief Cope instrument. This instrument measures emotion-focused, problem-focused, and dysfunctional coping and has been used in cancer survivors. Scores range from 1 to 5 with higher scores indicating better coping skills. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 5 months |
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| Secondary | Brief Cope - 6 Items | We assessed participants' coping during the five- and 12-month follow-up assessments using six items from the 28-item Brief Cope instrument. This instrument measures emotion-focused, problem-focused, and dysfunctional coping and has been used in cancer survivors. Scores range from 1 to 5 with higher scores indicating better coping skills. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Veteran Quality of Life Scale (VR-12) - Physical Health, 2 Items | We assessed subjective physical health using 2 items from the VR-12 (SF-12 for veterans), an established measure of overall QOL that includes perceptions of one's health that may be impacted by prostate cancer. The scores range from 1- 3 and higher scores correspond to better health. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Veteran Quality of Life Scale (VR-12) - Emotional Health, 3 Items | We assessed subjective emotional health using 3 items from the VR-12 (SF-12 for veterans), an established measure of overall QOL that includes perceptions of one's health that may be impacted by prostate cancer. The scores range from 1- 6 and higher scores correspond to better health. | N with non-missing data for the specific measure | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| 1 |
| 278 |
| 3 |
| 278 |
| 0 |
| 278 |
| EG001 | Enhanced Usual Care | Because of the strong evidence documenting symptom burden in PC survivors, the investigators believe that providing control subjects with some information about symptom self-management is warranted. The investigators further believe, based on the investigators' prior experience conducting RCTs, that offering some type of educational material for Veterans randomized to the control arm will increase their willingness to enroll in the study (as opposed to a pure usual care arm where they would not receive any such materials). Therefore, survivors randomized to the control condition will receive written material at the time of enrollment designed to educate them about PC symptoms and symptom management. Material will be approximately six pages in length, also written at or below an 8th grade reading level, and will include a summary of common symptoms experienced by prostate cancer survivors. | 3 | 278 | 1 | 278 | 0 | 278 |
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| Subdural hematoma | Nervous system disorders | Non-systematic Assessment | Patient was admitted to hospital with a subdural hematoma. |
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| Kidney Failure | Renal and urinary disorders | Non-systematic Assessment | Patient reported that he had been hospitalized for kidney failure. |
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| Stroke | Vascular disorders | Non-systematic Assessment | Patient suffered a stroke rendering him unable to speak. |
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Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |