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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Corporal Michael J. Crescenz VA Medical Center | FED |
| Fox Chase Cancer Center | OTHER |
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The purpose of this study is to develop a preference based decision aid to assess the treatment preferences of prostate cancer patients, and to analyze the interaction of treatment preferences, type of treatment received and their relationship with health related quality of life, satisfaction with care, decision regret, and psychological health of men with localized prostate cancer.
The objective is to test the comparative effectiveness of a conjoint analysis decision aid intervention compared to usual care. The investigators will identify preferred attributes of prostate cancer treatments that will help in designing a conjoint analysis decision aid to help patients weigh treatment attributes. The investigators will employ values markers to represent clusters of values for particular aspects of treatments that are valued most by individual patients. The investigators will test if the concordance between values markers and treatment received is predictive of objective outcomes and subjective outcomes. The study hypothesis is that conjoint task may help in treatment choice and prostate cancer patients whose treatment is more concordant with their values markers will have improved outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preference Based Decision Aid | Experimental | The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment. |
|
| Usual Care | No Intervention | Participants randomized into this group will have usual care from their doctors without any intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preference Based Decision Aid | Other | The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Satisfaction With Care | The investigators will measure Satisfaction with Care (PSQ-18). : The PSQ-18 scale measures satisfaction with care at baseline 3, 6, 12, and 24 months. Higher score indicates better satisfaction with care. Positive change indicates improvement in satisfaction with care. | baseline, 3, 6, 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Generic Health Related Quality of Life (HRQoL) | Generic HRQoL data is obtained from Medical Outcome Study Short Form (SF-36) that assesses 8 health domains. Scores on each domain range from 0 to 100, higher scores indicating better generic HRQoL. Change in SF-36 domain scores between baseline to 24 month will be calculated as score at 24 month-score minus score at baseline. Positive change value indicates improvement in HRQoL from baseline to 24 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Preference for Participation in Treatment Decision | The Control Preferences Scale (CPS) assesses the role that patients want to play and perceive playing in treatment decisions. | baseline, 3, 6, 12, and 24 months |
| Decision Conflict |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ravishankar Jayadevappa, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philadelphia Veteran's Affairs Medical Center | Philadelphia | Pennsylvania | 19104 | United States | ||
| University of Pennsylvania Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29587805 | Derived | Chhatre S, Jefferson A, Cook R, Meeker CR, Kim JH, Hartz KM, Wong YN, Caruso A, Newman DK, Morales KH, Jayadevappa R. Patient-centered recruitment and retention for a randomized controlled study. Trials. 2018 Mar 27;19(1):205. doi: 10.1186/s13063-018-2578-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Preference Based Decision Aid | The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment. Preference Based Decision Aid: The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes. |
| FG001 | Usual Care | Participants randomized into this group will have usual care from their doctors without any intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline analysis includes all participants that were randomized to the intervention group or to the usual care group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Preference Based Decision Aid | The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment. Preference Based Decision Aid: The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Satisfaction With Care | The investigators will measure Satisfaction with Care (PSQ-18). : The PSQ-18 scale measures satisfaction with care at baseline 3, 6, 12, and 24 months. Higher score indicates better satisfaction with care. Positive change indicates improvement in satisfaction with care. | All participants from both groups who were analyzed at end of 24 month follow-up. | Posted | Mean | Standard Error | units on a scale | baseline, 3, 6, 12 and 24 months |
|
24 months
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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 | Preference Based Decision Aid | The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment. Preference Based Decision Aid: The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ravishankar Jayadevappa | University of Pennsylvania | 215-898-3798 | jravi@pennmedicine.upenn.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 | Jul 30, 2014 | Aug 7, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| baseline to 24 month |
| Anxiety | Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale | baseline, 3, 6, 12, and 24 months |
| Urinary Symptoms | The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms | baseline, 3, 6, 12, and 24 months |
| Treatment Choice | The investigators will obtain data on primary and secondary treatments received, such as active surveillance, radical prostatectomy (RP), robotic-assisted laparoscopic prostatectomy (RALP), external beam radiation therapy (EBRT), brachytherapy (BT) or proton therapy (PT) via self report and verified from medical chart review. | 6 months |
| Depression | The Center for Epidemiologic Studies Depression (CES-D) scale will be used to measure depression. | baseline, 3, 6, 12, and 24 months |
| Satisfaction With Decision | The Satisfaction with Decision (SWD) will be used to measure satisfaction with decision at 3, 6, 12 and 24 months. | baseline, 3, 6, 12, and 24 months |
| Prostate Specific Health Related Quality of Life (HRQoL) | Prostate specific HRQoL data is obtained from Expanded Prostate Cancer Index (EPIC), and measures four broad domains of urinary, bowel, sexual and hormonal symptoms. Scores on each sub-scale range from 0 to 100, with higher scores indicating better prostate cancer HRQoL. Proportion of participants returning to baseline scores will be calculated by comparing scores at baseline and at 24 month. Higher proportion indicates higher number of participants recovering baseline function by 24 month. | Baseline to 24 month |
The Decision Conflict Scale (DCS) will be used to measure decision conflict.
| 12 and 24 months |
| Physician Trust | The Patient Trust-Wake Forest Physician Trust Scale will be used to measure trust | baseline |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| BG001 | Usual Care | Participants randomized into this group will have usual care from their doctors without any intervention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Satisfaction with care | In the Patient Satisfaction Questionnaire (PSQ-18) survey, 18 items are consolidated into seven subscales to assess satisfaction with medical care and six aspects of care. The subscale score ranges between 1 and 5, with a higher score indicating higher satisfaction. The PSQ-18 has demonstrated good internal consistency (Cronbach's a, .86) and excellent test-retest reliability (r, 0.92). | Mean | Standard Deviation | units on a scale |
|
| OG001 | Usual Care | Participants randomized into this group will have usual care from their doctors without any intervention |
|
|
| Secondary | Generic Health Related Quality of Life (HRQoL) | Generic HRQoL data is obtained from Medical Outcome Study Short Form (SF-36) that assesses 8 health domains. Scores on each domain range from 0 to 100, higher scores indicating better generic HRQoL. Change in SF-36 domain scores between baseline to 24 month will be calculated as score at 24 month-score minus score at baseline. Positive change value indicates improvement in HRQoL from baseline to 24 month. | All participants from both groups were analyzed at 24 month. Change in scores on domain of Physical Function is reported below. | Posted | Mean | Standard Deviation | score on a scale | baseline to 24 month |
|
|
|
| Secondary | Anxiety | Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale | Not Posted | baseline, 3, 6, 12, and 24 months | Participants |
| Secondary | Urinary Symptoms | The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms | Not Posted | baseline, 3, 6, 12, and 24 months | Participants |
| Secondary | Treatment Choice | The investigators will obtain data on primary and secondary treatments received, such as active surveillance, radical prostatectomy (RP), robotic-assisted laparoscopic prostatectomy (RALP), external beam radiation therapy (EBRT), brachytherapy (BT) or proton therapy (PT) via self report and verified from medical chart review. | Not Posted | 6 months | Participants |
| Secondary | Depression | The Center for Epidemiologic Studies Depression (CES-D) scale will be used to measure depression. | Not Posted | baseline, 3, 6, 12, and 24 months | Participants |
| Secondary | Satisfaction With Decision | The Satisfaction with Decision (SWD) will be used to measure satisfaction with decision at 3, 6, 12 and 24 months. | Not Posted | baseline, 3, 6, 12, and 24 months | Participants |
| Secondary | Prostate Specific Health Related Quality of Life (HRQoL) | Prostate specific HRQoL data is obtained from Expanded Prostate Cancer Index (EPIC), and measures four broad domains of urinary, bowel, sexual and hormonal symptoms. Scores on each sub-scale range from 0 to 100, with higher scores indicating better prostate cancer HRQoL. Proportion of participants returning to baseline scores will be calculated by comparing scores at baseline and at 24 month. Higher proportion indicates higher number of participants recovering baseline function by 24 month. | All participants from both groups were analyzed at 24 month. Proportion returning to baseline scores is reported for domain of urinary function below. | Posted | Number | Proportion of participants | Baseline to 24 month |
|
|
|
| Other Pre-specified | Preference for Participation in Treatment Decision | The Control Preferences Scale (CPS) assesses the role that patients want to play and perceive playing in treatment decisions. | Not Posted | baseline, 3, 6, 12, and 24 months | Participants |
| Other Pre-specified | Decision Conflict | The Decision Conflict Scale (DCS) will be used to measure decision conflict. | Not Posted | 12 and 24 months | Participants |
| Other Pre-specified | Physician Trust | The Patient Trust-Wake Forest Physician Trust Scale will be used to measure trust | Not Posted | baseline | Participants |
| 4 |
| 371 |
| 0 |
| 371 |
| 0 |
| 371 |
| EG001 | Usual Care | Participants randomized into this group will have usual care from their doctors without any intervention | 4 | 372 | 0 | 372 | 0 | 372 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |