Efficacy of a Couple-Focused mHealth Symptom Self-management Program

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: Prostate Cancer
• Intervention / Treatment: Behavioral: Prostate Cancer Education and Resources for Couples (PERC); Behavioral: usual care plus NCI website

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

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27559
      • University of North Carolina At Chapel Hill

Participation Criteria

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

1. be 40 to 75 years of age
2. 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;
3. 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);
4. experience prostate cancer-specific and/or general symptoms;
5. have a partner who is willing to participate.

The eligible partners must

1. be 18 years or older
2. be identified as the partner by the patient
3. 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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

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.	Behavioral: Prostate Cancer Education and Resources for Couples (PERC); 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.
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.	Behavioral: usual care plus NCI website; 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.

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	The Functional Assessment of Cancer Therapy - General (FACT-G) is 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 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. 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.	Baseline, month 4, 8 and 12

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	PROMIS Pain Interference - Short Form 6b is 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). Required by 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, month 4, 8, and 12
Change in Fatigue From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G) Scores	FACT-G is used to measure the change in the quality of life of patients and 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. Functional Assessment of Cancer Therapy-General 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.	Baseline, month 4, 8, and 12
Change in Sleep Disturbance From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS Scores	PROMIS Sleep Disturbance Short Form 8b is 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). 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 sleep disturbance sub-scale measured the extent to which participants experienced sleep disturbance over the past 7 days using a 5-point Likert scale. Higher scores reflect greater sleep disturbance. Score value ranges between 28.9-76.5.	Baseline, month 4, 8, and 12
Change in Anxiety From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Emotional Distress-Anxiety Short Form	PROMIS-Emotional Distress-Anxiety Short Form 7a is 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). 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, month 4, 8, and 12
Change in Depression From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Emotional Distress-Depression	PROMIS-Emotional Distress-Depression Short From 8b is used to measure the change in depression scores among patients from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Required by the PROMIS scoring instrument, for all PROMIS 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, month 4, 8, and 12
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Urinary Symptom Score (Patient Only)	Urinary symptom scores change by time were measured using patients' self-assessed urinary symptoms subscale of the Expanded Prostate Cancer Index Composite Short Form (EPIC 26) which is designed to evaluate patient urinary function and bother after prostate cancer treatment. EPIC26 was used at Baseline (T1) to T2 (4 months post-T1), T3 (8 months post-T1), and T4 (12 months post-T1). EPIC26 evaluates patients' functional and symptom-specific issues, including urinary, bowel, sexual, and hormonal symptoms and bother. The patient self-report contains 26 items, and the score range is 0-100. Higher scores represent fewer prostate cancer symptoms and better prostate cancer-related quality of life.	Baseline, month 4, 8, and 12
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Bowel Symptom Score (Patient Only)	Bowel symptom scores change by time and were measured using patients' self-assessed bowel symptoms subscale of the Expanded Prostate Cancer Index Composite Short Form (EPIC 26) which is designed to evaluate patient function and bother after prostate cancer treatment. EPIC was used at Baseline (T1) to T2 (4 months post-T1), T3 (8 months post-T1), and T4 (12 months post-T1). EPIC26 evaluates patients' functional and symptom-specific issues, including urinary, bowel, sexual, and hormonal symptoms and bother. The patient self-report contains 26 items, and the score range is 0-100. Higher scores represent fewer prostate cancer symptoms and better prostate cancer-related quality of life.	Baseline, month 4, 8, and 12
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Sexual Symptom Score (Patients Only)	Sexual symptom scores change by time were measured using patients' self-assessed sexual symptoms subscale of the Expanded Prostate Cancer Index Composite Short Form (EPIC 26) which is designed to evaluate patient function and bother after prostate cancer treatment. EPIC was used at Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). EPIC26 evaluates patients' functional and symptom-specific issues, including urinary, bowel, sexual, and hormonal symptoms and bother. The patient self-report contains 26 items, and the score range is 0-100. Higher scores represent fewer prostate cancer symptoms and better prostate cancer-related quality of life.	Baseline, month 4, 8, and 12
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Hormonal Symptom Score (Patient Only)	Hormonal symptom scores change by time were measured using patients' self-assessed hormonal subscale of the Expanded Prostate Cancer Index Composite Short Form (EPIC 26) which is designed to evaluate patient function and bother after prostate cancer treatment. EPIC was used at Baseline (T1) to T2 (4 months post-T1), T3 (8 months post-T1), and T4 (12 months post-T1). EPIC26 evaluates patients' functional and symptom-specific issues, including urinary, bowel, sexual, and hormonal symptoms and bother. The patient self-report contains 26 items, and the score range is 0-100. Higher scores represent fewer prostate cancer symptoms and better prostate cancer-related quality of life.	Baseline, month 4, 8, and 12
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Urine Symptom Score (Partners Only)	Urinary symptom scores change by time were measured using caregiver assessed urinary symptoms subscale of the 4-item caregiver version of the Expanded Prostate Cancer Index Composite Short Form which is designed to assess how much of a bother/burden patients' prostate cancer symptoms were for the partners themselves. EPIC-caregiver was used Baseline (T1) to T2 (4 months post-T1), T3 (8 months post-T1), and T4 (12 months post-T1). The partner reported how patients' urinary and bowel, sexual, and hormonal symptoms bothered the caregivers. The score range is 0-100. Higher scores represent fewer bother partners reported and better prostate cancer-related quality of life.	Baseline, month 4, 8, and 12
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Bowel Symptom (Partners Only)	Bowel symptom scores change by time were measured using caregiver-assessed bowel symptoms subscale of the 4-item caregiver version of the Expanded Prostate Cancer Index Composite Short Form which is designed to assess how much of a bother/burden patients' prostate cancer symptoms were for the partners themselves. EPIC-caregiver was used Baseline (T1) to T2 (4 months post T1), T3 (8 months post-T1), and T4 (12 months post-T1). The partner reported how patients' urinary and bowel, sexual, and hormonal symptoms bothered the caregivers. The score range is 0-100. Higher scores represent fewer bother partners reported and better prostate cancer-related quality of life.	Baseline, month 4, 8, and 12
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Hormonal Symptom Score Partners Only)	Hormonal symptom scores change by time were measured using caregiver-assessed hormonal subscale of the 4-item caregiver version of the Expanded Prostate Cancer Index Composite Short Form which is designed to assess how much of a bother/burden patients' prostate cancer symptoms were for the partners themselves. EPIC-caregiver was used Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12 months post-T1). The partner reported how patients' urinary and bowel, sexual, and hormonal symptoms bothered the caregivers. The score range is 0-100. Higher scores represent fewer bother partners reported and better prostate cancer-related quality of life.	Baseline, month 4, 8, and 12
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Sexual Symptom Score Partners Only)	Sexual symptom scores change by time were measured using caregiver assessed sexual symptoms subscale of the 4-item caregiver version of the Expanded Prostate Cancer Index Composite Short Form which is designed to assess how much of a bother/burden patients' prostate cancer symptoms were for the partners themselves. EPIC-caregiver was used Baseline (T1) to T2 (4 months post T1), T3 (8 months post-T1), and T4 (12 months post-T1). The partner reported how patients' urinary and bowel, sexual, and hormonal symptoms bothered the caregivers. The score range is 0-100. Higher scores represent fewer bother partners reported and better prostate cancer-related quality of life.	Baseline, month 4, 8, and 12
Change in Self-efficacy Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by the Lewis Cancer Self-Efficacy Scale	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.	Baseline, month 4, 8, and 12
Change in Informational Support Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Informational Support Short Form	The Patient-Reported Outcomes Measurement Information System (PROMIS) 8a is a National Institute of Health-funded initiative to develop and validate patient-reported outcomes (PROs) for clinical research and practice. PROMISE is a set of measures that evaluates and monitors physical, mental, and social health. It uses a 5-point Likert scale. The scoring process involved collecting PROMIS data from participants and calculating the PROMIS score as the sum of responses to each question. Then Health Measures Scoring Service was used to calculate the PROMIS T-score - the standardized score. Specifically, PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population (T-scores have a mean of 50 and a standard deviation (SD) of 10). On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.	Baseline, month 4, 8, and 12
Change in Instrumental Support Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Measured by PROMIS Instrumental Support-Short Form 8a	The Patient-Reported Outcomes Measurement Information System (PROMIS) 8a is a National Institute of Health-funded initiative to develop and validate patient-reported outcomes (PROs) for clinical research and practice. PROMISE is a set of measures that evaluates and monitors physical, mental, and social health. It uses a 5-point Likert scale. The scoring process involved collecting PROMIS data from participants and calculating the PROMIS score as the sum of responses to each question. Then Health Measures Scoring Service was used to calculate the PROMIS T-score - the standardized score. Specifically, PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population (T-scores have a mean of 50 and a standard deviation (SD) of 10). On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.	Baseline, month 4, 8, and 12
Change in Appraisal of Illness Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Measured by Appraisal of Illness Scale	The appraisal of Illness scale is used to measure changes in perception of prostate cancer and related issues among patients and their partners. The Appraisal of Illness scale is a 20-item measure that uses Likert Scales ranging from 1 to 5 (very false to very true). The score range is 1-5. The higher score indicated a better cognitive appraisal of the illness the patient or partner had. The score is calculated by the Prorated mean scale scores. The formula is prorated scale score =[SUM OF ITEM SCORES]x[N OF ITEMS IN SCALE]/[N OF ITEMS ANSWERED]. Measurements were performed at 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. Higher scores indicate better support.	Baseline, month 4, 8, and 12

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Lixin (Lee) Song, RN, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Song L, Nielsen ME, Chen RC, Rini C, Keyserling TC, Idiagbonya E, Fuller GP, Northouse L, Palmer MH, Tan X. Testing the efficacy of a couple-focused, tailored eHealth intervention for symptom self-management among men with prostate cancer and their partners: the study protocol. Trials. 2022 Jan 4;23(1):12. doi: 10.1186/s13063-021-05948-5.

Helpful Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

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): October 3, 2024
• Last Update Submitted That Met QC Criteria: September 9, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; self-management; caregiving; mHealth; care transition; social support; self-efficacy; symptom; family research; healthy behavior
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• 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