- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03489057
Efficacy of a Couple-Focused mHealth Symptom Self-management Program
August 31, 2023 updated by: UNC Lineberger Comprehensive Cancer Center
Testing the Efficacy of a Couple-Focused, Tailored mHealth Intervention for Symptom Self-Management Among Men With Prostate Cancer and Their Partners
In this study, the investigators propose to test the efficacy of a couple-focused, web-based tailored prostate cancer symptom management program, Prostate Cancer Education and Resources for Couples (PERC) in a randomized clinical trial.
A two-group (PERC versus National Cancer Institute (NCI) website plus treatment as usual) randomized controlled design will be used, and data will be collected at baseline (T1), 4 (T2), 8 (T3), and 12 months (T4) among 300 patients completing initial treatment for localized prostate cancer and their intimate partners (i.e., 600 participants in total).
Study Overview
Status
Completed
Conditions
Detailed Description
This randomized clinical trial aims to test the efficacy of a couple-focused, web-based tailored prostate cancer symptom management program, Prostate Cancer Education and Resources for Couples (PERC).
The study participants will include 300 patients completing initial treatment for localized prostate cancer and their intimate partners (i.e., 300 dyads and 600 individuals).
After informed consent, we will conduct baseline assessment (T1), randomly assign eligible participants to either PERC or the National Cancer Institute (NCI) website, and then collect data at 4 (T2), 8 (T3), and 12 months (T4) post-T1.
Study Type
Interventional
Enrollment (Actual)
560
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27559
- University of North Carolina at Chapel Hill
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
The eligible patients must
- be 40 to 75 years of age
- be within 16 weeks (4 months) after completing initial treatment for localized prostate cancer as confirmed by patient and biopsy pathology report) with curative intent, i.e., surgery or radiotherapy +/- hormonal treatment;
- have no previous cancer history within the past 2 years and not currently in treatment for cancer, or have a concurrent cancer (excluding non-melanomatous skin cancer);
- experience prostate cancer-specific and/or general symptoms;
- have a partner who is willing to participate.
The eligible partners must
- be 18 years or older
- be identified as the partner by the patient
- not have been diagnosed with cancer or receiving treatment for cancer within the past 12 months (non-melanomatous skin cancer diagnosis/treatment is acceptable) so that couples can focus their efforts on managing prostate cancer.
Exclusion Criteria:
Patients and their partners will be excluded from the study if they:
- Do not read and speak English (evidenced by their understanding and responses to screening questions and self-reported ability to read English);
- Have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PERC Program
Prostate Cancer Education and Resources for Couples (PERC) program.
Participants assigned to experimental condition will receive access to the PERC website.
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PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it.
PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.
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Active Comparator: usual care plus NCI website
Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage.
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The usual care plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life over time as assessed by Functional Assessment of Cancer Treatment (FACT-G) scores
Time Frame: Baseline, month 12
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FACT-G will be used to measure change in quality of life of patient and partner from baseline (T1) to T2 (4 months post-T1), T3 (8-months post-T1), and T4 (12-months post-T1).
Change from baseline is the post-Baseline values minus the Baseline value.
Functional assessment of Cancer Therapy-General (FACT-G) is a 27 item survey which 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.
Higher scores indicate better well-being.
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Baseline, month 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain from baseline to 4-, 8-, and 12-month post baseline as assessed by Patient-Reported Outcome Measurement Information System (PROMIS) scores
Time Frame: Baseline, month 4, 8, and 12
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PROMIS Pain Interference - Short Form 6b will be used to measure change in Pain Interference among patients and their partners from Baseline (T1) to T2 (4 months post-T1), T3 (8-mon post-T1), and T4 (12-mon post-T1).
Total raw scores will be 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.
Change from baseline is the post-Baseline values minus the Baseline value.
The pain subscale 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.
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Baseline, month 4, 8, and 12
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Change in Fatigue from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS scores
Time Frame: Baseline, month 4, 8, and 12
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PROMIS Fatigue -Short Form 7a will be used to measure change in Fatigue among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1).
Total raw scores will be 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.
Change from baseline is the post-Baseline values minus the Baseline value.The fatigue sub-scale will measure 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.
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Baseline, month 4, 8, and 12
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Change in sleep disturbance from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS scores
Time Frame: Baseline, month 4, 8, and 12
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PROMIS Sleep Disturbance Short Form 8b will be used to examine change in sleep quality of patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1).
Total raw scores will be 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.
Change from baseline is the post-Baseline values minus the Baseline value.The sleep disturbance sub-scale measures the extent to which participant experience sleep disturbance over the past 7 days using a 5-point Likert scale.
Higher scores reflect greater sleep disturbance.
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Baseline, month 4, 8, and 12
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Change in Anxiety from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS-Emotional Distress-Anxiety Short Form
Time Frame: Baseline, month 4, 8, and 12
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PROMIS-Emotional Distress-Anxiety Short Form 7a will be used to examine change in anxiety among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1).
Total raw scores will be 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.
Change from baseline is the post-Baseline values minus the Baseline value.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, where higher scores reflect higher anxiety.
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Baseline, month 4, 8, and 12
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Change in depression from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS-Emotional Distress-Depression
Time Frame: Baseline, month 4, 8, and 12
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PROMIS-Emotional Distress-Depression Short From 8b will be used to measure change in depression scores among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1).
Total raw scores will be 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.
Change from baseline is the post-Baseline values minus the Baseline value.
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, where higher scores indicate greater depressive symptoms.
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Baseline, month 4, 8, and 12
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Change in prostate cancer patient function and bother scores from baseline to 4-, 8-, and 12-month post baseline as assessed by the Expanded Prostate Cancer Index Composite (EPIC)
Time Frame: Baseline, month 4, 8, and 12
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The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment.
EPIC will be used to measure change in health related quality of life scores among patients from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1).
Change from baseline is the post-Baseline value minus the Baseline value.
It contains 26 items within 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal.
Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life.
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Baseline, month 4, 8, and 12
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Change in caregiver ratings of how patient's prostate cancer related symptoms affect their own life from baseline to 4-, 8-, and 12-month post baseline as assessed by the Prostate Cancer Related Symptoms Caregiver Short Form
Time Frame: Baseline, month 4, 8, and 12
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The Prostate Cancer Related Symptoms Caregiver Short Form will be used to measure changes in caregiver scores from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1).
Change from baseline is the post-Baseline value minus the Baseline value.The questionnaire is a 4-item assessment about how the patient's hormone, sexual, bowel, and urinary function has affected the caregiver over the past 4 weeks.
Items are ranked on a 5-point Likert Scale where higher scores indicate greater bother associated with the patient's symptoms.
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Baseline, month 4, 8, and 12
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Change in self-efficacy scores from baseline to 4-, 8-, and 12-month post baseline as assessed by the Lewis Cancer Self-Efficacy scale
Time Frame: Baseline, month 4, 8, and 12
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The Lewis Cancer Self-Efficacy will be used to measure change in patient and partner feelings of self-efficacy in dealing with the patient's cancer diagnosis and treatment from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1).
Change from baseline is the post-Baseline values minus the Baseline value.
Patients will rate statements about how confident they feel on a scale from 1 to 10, where higher scores indicate higher self-efficacy.
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Baseline, month 4, 8, and 12
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Change in Informational Support scores from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS-Informational Support Short Form
Time Frame: Baseline, month 4, 8, and 12
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PROMIS Informational Support Short Form 8a will be used to assess changes in patient and partner reported informational support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1).
Change from baseline is the post-Baseline values minus the Baseline value.
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Baseline, month 4, 8, and 12
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Change in Emotional Support System scores from baseline to 4-, 8-, and 12-month post baseline as measured by PROMIS-Emotional support
Time Frame: Baseline, month 4, 8, and 12
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The PROMIS Emotional Support System-Short Form 8a will be used to assess changes in the self-reported emotional support system of patients and their partners using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1).
Change from baseline is the post-Baseline values minus the Baseline value.
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Baseline, month 4, 8, and 12
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Change in Instrumental Support scores from baseline to 4-, 8-, and 12-month post baseline as measured by PROMIS Instrumental Support-Short Form 8a
Time Frame: Baseline, month 4, 8, and 12
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The PROMIS Instrumental Support-Short Form 8a will be used to assess changes in patient and partner reported instrumental support system from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1).
Change from baseline is the post-Baseline values minus the Baseline value.
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Baseline, month 4, 8, and 12
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Change in Interpersonal Support scores from baseline to 4-, 8-, and 12-month post baseline as measured by Interpersonal Support Evaluation List -12 (ISEL-12)
Time Frame: Baseline, month 4, 8, and 12
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The ISEL-12 will be used to measure change in social support from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1) among patients and their partners.
The ISEL-12 is a 12 item measure, where higher scores indicate greater social support.
Change from baseline is the post-Baseline values minus the Baseline value.
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Baseline, month 4, 8, and 12
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Change in Appraisal of Illness scores from baseline to 4-, 8-, and 12-month post baseline as measured by Appraisal of Illness scale
Time Frame: Baseline, month 4, 8, and 12
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Appraisal of Illness scale will be used to measure change in perception of prostate cancer and related issues among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1).
Change from baseline is the post-Baseline values minus the Baseline value.The Appraisal of Illness scale is a 20 item measure that uses Likert Scales ranging from Very False to Very True.
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Baseline, month 4, 8, and 12
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Change in Dietary Risk Assessment scores from baseline to 4-, 8-, and 12-month post baseline as measured by Dietary Risk Assessment scale
Time Frame: Baseline, month 4, 8, and 12
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Change in Dietary Risk Assessment scores will be used to measure changes in dietary risk from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1).
Change from baseline is the post-Baseline values minus the Baseline value.
Patients and their partners will be asked how often they consume different foods over the past month or week and will respond using a Likert Scale to report how much of each food item they have consumed.
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Baseline, month 4, 8, and 12
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Change in Older Adult's Sedentary Time from baseline to 4-, 8-, and 12-month post baseline as measured by Measure of Older Adult's Sedentary Time (MOST)
Time Frame: Baseline, month 4, 8, and 12
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The Measure of Older Adult's Sedentary Time will be used to measure change in self-reported sedentary time from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1).
Change from baseline is the post-Baseline values minus the Baseline value.
Participants will self-report how much time they spend doing various sedentary activities during the past week.
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Baseline, month 4, 8, and 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Lixin (Lee) Song, RN, PhD, University of North Carolina, Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2018
Primary Completion (Actual)
July 6, 2022
Study Completion (Actual)
July 31, 2022
Study Registration Dates
First Submitted
March 13, 2018
First Submitted That Met QC Criteria
March 28, 2018
First Posted (Actual)
April 5, 2018
Study Record Updates
Last Update Posted (Actual)
September 1, 2023
Last Update Submitted That Met QC Criteria
August 31, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC 1713
- 1R01NR016990-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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