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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR016990 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
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This is a proof-of-concept pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition.
In this proof-of-concept study, our multidisciplinary team will conduct a pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition. We will randomly assign 21 cancer patients with newly created ostomies for cancer treatment with curative intent and their primary caregivers to the PRISMS or usual care groups (21 patient-caregiver dyads, a total of 42 individuals). PRISMS is defined as a personalized psychoeducational website including monitoring and personal feedback. We will conduct pre- and post-assessments of QOL and PRO (symptoms) at baseline upon enrollment and 2 months later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRISMS | Experimental | In addition to usual care, participants assigned to this arm will have access to our Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) program. |
|
| Usual Care | No Intervention | Participants assigned to this arm will receive the standard of care that is provided to all patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) | Behavioral | Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications (e.g., skin infection, fatigue) from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through videoconferencing/telephone from the research nurse and also their healthcare providers at the hospital(s) if they experience moderate to severe symptoms and/or abnormal sign (e.g., body temperature is greater than 98.6 C |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Number | The enrollment rate is defined as the number of potentially eligible couples (dyads) who have consented to participate in the study. 1 Dyad = 1 participant + their caregiver. Potentially eligible dyads (subjects and their caregivers) were approached and informed about the study. then the number of dyads who consented and completed. | Baseline |
| Number of Potentially Eligible Dyads Participants Actually Enrolled in the Study | Potentially Eligible Dyads Participants Actually Enrolled in the Study will be evaluated by the number of dyads who successfully consented and completed the baseline survey among all people approached for the study. 1 Dyad = 1 participant + their caregiver. | Baseline, after consent |
| Number of Dyads Remained in the Study and Completed the Post-Intervention Follow-Up Survey. | The number of dyad Participants Enrolled who Remained in the Study and Completed the Post-Intervention Follow-Up Survey was assessed by the number of enrolled dyad participants who completed the 2-month follow-up survey at the end of the study period. | Up to 3 months (2-month follow up survey) |
| Usability of Reported Outcomes - Patient Reported Outcomes - Informed Symptom Management System (PRISMS) | Usability of Reported Outcomes - Patient Reported Outcomes - Informed Symptom Management System (PRISMS) evaluates three aspects: General, content, and navigation, contains 19 items on a 5-point Likert scale, where 1 is "strongly disagree" and 5 is "strongly agree". The score for each aspect was calculated as the sum of the scores from all items in this aspect. The scores ranged between 5 and 25 for General and Content, and the Navigation score ranged between 9 and 45. The higher score of the specific aspect that patients and their caregivers reported indicates the better usability of the aspect. This survey was offered separately at the follow-up visit to patients and their caregivers. Participants who completed at least 80.00% of the questions were included in the analysis. Usual Care and Informed Symptom Management System (PRISMS) group scores were compared. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of Quality of Life Change Over Time as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G). | Quality of Life Change Over Time as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G) at baseline and follow-up visit to patients and their caregivers separately. Change from baseline is the post-baseline value minus the Baseline value. FACT-G is a 27-item survey that assesses physical, social/family, emotional, and functional well-being on a 5-point Likert scale, with 0 indicating "not at all" and 4 indicating "very much" in response to item questions. The total FACT-G score is calculated as the sum of four sub-scores including physical, social/family, emotional, and functional well-being. Total scores range between 0-108. Higher scores indicated better well-being. It has also demonstrated sensitivity to change over time Mean FACT-G difference between baseline and 2 months were presented. |
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Inclusion Criteria:
Patients must:
Caregivers must:
Exclusion Criteria:
Patients and their caregivers will be excluded if they:
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| Name | Affiliation | Role |
|---|---|---|
| Lixin Song, RN, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37301841 | Derived | Xu S, Tan X, Ma C, McElyea RS, Shieh K, Stover AM, Smith A, Stitzenberg K, Basch E, Song L. An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial. BMC Cancer. 2023 Jun 10;23(1):532. doi: 10.1186/s12885-023-10919-x. |
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This is a pilot study with very small sample size and specific inclusion criteria. Sharing data with others may increase the risk to patient confidentiality.
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In total 46 participants, 23 patients, and 23 patients' caregivers were started to the study. Patients and their caregivers were graded as dyed; 16 dyed in the PRISM arm and 7 dyed in the control arm were enrolled in the study.
Participants were enrolled in the study between 11/02/2020 - 8/10/2021 at one cancer center in North Carolina.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Participants assigned to this arm will receive the standard of care that is provided to all patients. |
| FG001 | Caregiver-Usual Care | The primary caregiver of the participants assigned to this arm will receive the standard of care that is provided to all patients. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Aug 23, 2019 |
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|
| Up to 2 months (Follow up survey) |
| Satisfaction With the PRISMS Program | The satisfaction survey evaluates satisfaction with various aspects, contains 9 items on a 5-point Likert scale of 1 to 5, and higher scores reflect better satisfaction. Questions: Q1. The amount of time to review the program every time. Q2. Ease of navigating. Q3. Information I received. Q4. Quality of the information I received. Q5. The program has increased my knowledge about managing my symptoms and complications. Q6. The program has improved how I manage my symptoms and complications. Q7. The program has improved how I communicate with my family about sensitive topics related to my cancer care. Q8. The time and effort took me to complete. Q9. My knowledge about how my cancer has affected my partner and our relationship was improved. This survey was offered at the follow-up visit to patients and their caregivers separately. More than 80.00% of the questions answered were included in the analysis. The mean score for each question for Usual Care and PRISMS were compared. | 2-month followup survey |
| baseline , 2 months |
| Difference of Anxiety Change Over Time as Assessed by PROMIS-Emotional Distress-Anxiety Short Form 7a | Difference of Anxiety Change Over Time as Assessed by PROMIS-Emotional Distress-Anxiety Short Form 7a used to examine the change in anxiety among patients and their caregivers separately, from Baseline to follow up (2 months). For all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The anxiety sub-scale of the PROMIS item bank measures the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with the total scores range from 36.3 to 82.7 with higher scores reflect higher anxiety. | Baseline and 2 months |
| Difference of Depression Change Over Time as Assessed by PROMIS-Emotional Distress-Depression Short From 8b | Change of Depression Change Over Time as Assessed by PROMIS-Emotional Distress-Depression Short From 8b will be assessed by PROMIS-Emotional Distress-Depression Short From 8b. It is used to measure the change in depression scores among patients and their partners from Baseline (T1) to T2 (2 months post-T1). Required by the PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The depression sub-scale of the PROMIS item bank measures the extent to which participants experience depressive symptoms in the past 7 days using a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with the total scores range from 24.7 to 63.5 with higher scores indicate greater depressive symptoms. | Baseline, 2 months |
| Difference Pain Score Over Time as Assessed by PROMIS Pain Interference - Short Form 6b | Change Pain Score Over Time as Assessed by PROMIS Pain Interference - Short Form 6b will be assessed by PROMIS Pain Interference - Short Form 6b. It is used to measure the change in Pain. It was offered to patients and their caregivers separately. Required by the PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The pain measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater Pain Interference. The score value ranges between 41-78.3. | Baseline, 2 months |
| Difference of Fatigue Change Over Time as Assessed by PROMIS Fatigue -Short Form 7a | PROMIS Fatigue -Short Form 7a is used to measure the change in Fatigue among patients and their caregivers separately, from Baseline (T1) to T2 (2 months post-T1). Required by the PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The fatigue scale measures the extent to which patients and their partners experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue. Score value ranges between 29.4 - 83.2. | Baseline, 2 months |
| Change in Sleep Among Caregivers. | Change in Sleep among caregivers. was assessed by the 22-item version of the Zarit Burden Interview is a caregiver self-reported instrument. It is used to assess caregiving burden change among caregivers from Baseline (T1) to T2 (2 months post-T1). Each item on the interview is a statement that the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Higher scores reflect more severe burden, 0-21: no to mild burden; 21-40: mild to moderate burden; 41-60: moderate to severe burden; ≥ 61: severe burden. The score value ranges between 0-88. | Baseline, 2 months |
| FG002 | PRISMS | Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s). |
| FG003 | Caregiver-PRISMS | The primary caregiver of the participants assigned to receive eceive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s). |
| COMPLETED |
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| NOT COMPLETED |
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|
Subjects started to study interventions.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Participants assigned to this arm will receive the standard of care that is provided to all patients. |
| BG001 | Caregiver-Usual Care | The primary caregiver of the participants assigned to this arm will receive the standard of care that is provided to all patients. |
| BG002 | PRISMS | Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s). |
| BG003 | Caregiver-PRISMS | The primary caregiver of the participants assigned to receive eceive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
| 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 | Enrollment Number | The enrollment rate is defined as the number of potentially eligible couples (dyads) who have consented to participate in the study. 1 Dyad = 1 participant + their caregiver. Potentially eligible dyads (subjects and their caregivers) were approached and informed about the study. then the number of dyads who consented and completed. | Potentially eligible dyads (subjects and their caregivers) were approached and informed about the study. A total of 29 dyads were approached and were eligible and 25 dyads were consented. | Posted | Number | Number of dyad participants | Baseline |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Potentially Eligible Dyads Participants Actually Enrolled in the Study | Potentially Eligible Dyads Participants Actually Enrolled in the Study will be evaluated by the number of dyads who successfully consented and completed the baseline survey among all people approached for the study. 1 Dyad = 1 participant + their caregiver. | 25 dyads were consented. | Posted | Number | Number of dyad participants | Baseline, after consent |
|
| |||||||||||||||||||||||||||
| Primary | Number of Dyads Remained in the Study and Completed the Post-Intervention Follow-Up Survey. | The number of dyad Participants Enrolled who Remained in the Study and Completed the Post-Intervention Follow-Up Survey was assessed by the number of enrolled dyad participants who completed the 2-month follow-up survey at the end of the study period. | The number of dyads who started to study completed baseline and post-intervention survey. Twenty-five dyads consented, and 23 of them completed the baseline survey. | Posted | Number | Number of dyad participants | Up to 3 months (2-month follow up survey) |
|
| |||||||||||||||||||||||||||
| Primary | Usability of Reported Outcomes - Patient Reported Outcomes - Informed Symptom Management System (PRISMS) | Usability of Reported Outcomes - Patient Reported Outcomes - Informed Symptom Management System (PRISMS) evaluates three aspects: General, content, and navigation, contains 19 items on a 5-point Likert scale, where 1 is "strongly disagree" and 5 is "strongly agree". The score for each aspect was calculated as the sum of the scores from all items in this aspect. The scores ranged between 5 and 25 for General and Content, and the Navigation score ranged between 9 and 45. The higher score of the specific aspect that patients and their caregivers reported indicates the better usability of the aspect. This survey was offered separately at the follow-up visit to patients and their caregivers. Participants who completed at least 80.00% of the questions were included in the analysis. Usual Care and Informed Symptom Management System (PRISMS) group scores were compared. | Thirty -four participants (17 patients and 17 caregivers) who completed the survey questionnaires were included. | Posted | Mean | Standard Deviation | score on a scale | Up to 2 months (Follow up survey) |
| |||||||||||||||||||||||||||
| Primary | Satisfaction With the PRISMS Program | The satisfaction survey evaluates satisfaction with various aspects, contains 9 items on a 5-point Likert scale of 1 to 5, and higher scores reflect better satisfaction. Questions: Q1. The amount of time to review the program every time. Q2. Ease of navigating. Q3. Information I received. Q4. Quality of the information I received. Q5. The program has increased my knowledge about managing my symptoms and complications. Q6. The program has improved how I manage my symptoms and complications. Q7. The program has improved how I communicate with my family about sensitive topics related to my cancer care. Q8. The time and effort took me to complete. Q9. My knowledge about how my cancer has affected my partner and our relationship was improved. This survey was offered at the follow-up visit to patients and their caregivers separately. More than 80.00% of the questions answered were included in the analysis. The mean score for each question for Usual Care and PRISMS were compared. | Thirty -four participants (17 patients and 17 caregivers) who completed the survey questionnaires were included. | Posted | Mean | Standard Deviation | score on a scale | 2-month followup survey |
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| Secondary | Difference of Quality of Life Change Over Time as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G). | Quality of Life Change Over Time as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G) at baseline and follow-up visit to patients and their caregivers separately. Change from baseline is the post-baseline value minus the Baseline value. FACT-G is a 27-item survey that assesses physical, social/family, emotional, and functional well-being on a 5-point Likert scale, with 0 indicating "not at all" and 4 indicating "very much" in response to item questions. The total FACT-G score is calculated as the sum of four sub-scores including physical, social/family, emotional, and functional well-being. Total scores range between 0-108. Higher scores indicated better well-being. It has also demonstrated sensitivity to change over time Mean FACT-G difference between baseline and 2 months were presented. | Thirty -four participants (17 patients and 17 caregivers) who completed the survey questionnaires were included. | Posted | Mean | Standard Deviation | score on a scale | baseline , 2 months |
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| Secondary | Difference of Anxiety Change Over Time as Assessed by PROMIS-Emotional Distress-Anxiety Short Form 7a | Difference of Anxiety Change Over Time as Assessed by PROMIS-Emotional Distress-Anxiety Short Form 7a used to examine the change in anxiety among patients and their caregivers separately, from Baseline to follow up (2 months). For all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The anxiety sub-scale of the PROMIS item bank measures the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with the total scores range from 36.3 to 82.7 with higher scores reflect higher anxiety. | Thirty -four participants (17 patients and 17 caregivers) who completed the survey questionnaires were included. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 months |
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| Secondary | Difference of Depression Change Over Time as Assessed by PROMIS-Emotional Distress-Depression Short From 8b | Change of Depression Change Over Time as Assessed by PROMIS-Emotional Distress-Depression Short From 8b will be assessed by PROMIS-Emotional Distress-Depression Short From 8b. It is used to measure the change in depression scores among patients and their partners from Baseline (T1) to T2 (2 months post-T1). Required by the PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The depression sub-scale of the PROMIS item bank measures the extent to which participants experience depressive symptoms in the past 7 days using a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with the total scores range from 24.7 to 63.5 with higher scores indicate greater depressive symptoms. | Participants who completed the survey | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months |
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| Secondary | Difference Pain Score Over Time as Assessed by PROMIS Pain Interference - Short Form 6b | Change Pain Score Over Time as Assessed by PROMIS Pain Interference - Short Form 6b will be assessed by PROMIS Pain Interference - Short Form 6b. It is used to measure the change in Pain. It was offered to patients and their caregivers separately. Required by the PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The pain measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater Pain Interference. The score value ranges between 41-78.3. | Thirty -four participants (17 patients and 17 caregivers) who completed the survey questionnaires were included. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months |
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| Secondary | Difference of Fatigue Change Over Time as Assessed by PROMIS Fatigue -Short Form 7a | PROMIS Fatigue -Short Form 7a is used to measure the change in Fatigue among patients and their caregivers separately, from Baseline (T1) to T2 (2 months post-T1). Required by the PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The fatigue scale measures the extent to which patients and their partners experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue. Score value ranges between 29.4 - 83.2. | Thirty -four participants (17 patients and 17 caregivers) who completed the survey questionnaires were included. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months |
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| Secondary | Change in Sleep Among Caregivers. | Change in Sleep among caregivers. was assessed by the 22-item version of the Zarit Burden Interview is a caregiver self-reported instrument. It is used to assess caregiving burden change among caregivers from Baseline (T1) to T2 (2 months post-T1). Each item on the interview is a statement that the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Higher scores reflect more severe burden, 0-21: no to mild burden; 21-40: mild to moderate burden; 41-60: moderate to severe burden; ≥ 61: severe burden. The score value ranges between 0-88. | Patients' caregivers participants responded to the survey questionnaire. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 months |
|
Not available, Adverse Events were not collected.
The protocol does not require Adverse Event Collections and/or All-Cause Mortality data. Deaths and adverse events were not assessed.Since this study is a minimum risk educational intervention study. No Adverse Event happened during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Participants assigned to this arm will receive the standard of care that is provided to all patients. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Caregiver-Usual Care | The primary caregiver of the participants assigned to this arm will receive the standard of care that is provided to all patients. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | PRISMS | Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Caregiver-PRISMS | The primary caregiver of the participants assigned to receive eceive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s). | 0 | 0 | 0 | 0 | 0 | 0 |
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Investigators' joint publication is required.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xianming Tan PhD | University of North Carolina Lineberger Comprehensive Cancer Center | 919-966-8450 | xianming@email.unc.edu |
| May 7, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D010051 | Ovarian Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| OG002 | PRISMS Patients | Patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s). |
| OG003 | PRISMS- Caregivers | Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s). |
|
|
| OG002 | PRISMS | Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s). |
| OG003 | PRISMS -Caregivers | Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s). |
|
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| OG002 | PRISMS | Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s). |
| OG003 | PRISMS- Caregivers | Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s). |
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| PRISMS |
Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s). |
| OG003 | PRISMS - Caregivers | Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s). |
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Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s). |
| OG003 | PRISMS -Caregivers | Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s). |
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Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and also their healthcare providers at the hospital(s).
| OG003 | PRISMS - Caregivers | Caregivers of patient participants will receive personalized self-care information and guidance based on their symptoms and signs of complications from the web-based telehealth PRISMS program. They will also have access through this website to a peer support online forum that is moderated by a research nurse as well as professional support through video conferencing/telephone from the research nurse and their healthcare providers at the hospital(s). |
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