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
2 other identifiers
interventional
560
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started May 2018
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2018
CompletedFirst Posted
Study publicly available on registry
April 5, 2018
CompletedStudy Start
First participant enrolled
May 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedResults Posted
Study results publicly available
October 3, 2024
CompletedOctober 3, 2024
September 1, 2024
4.1 years
March 13, 2018
February 29, 2024
September 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
Change in Pain From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by Patient-Reported Outcome Measurement Information System (PROMIS) Scores
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
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
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
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
Baseline, month 4, 8, and 12
- +12 more secondary outcomes
Study Arms (2)
PERC Program
EXPERIMENTALProstate Cancer Education and Resources for Couples (PERC) program. Participants assigned to experimental condition will receive access to the PERC website.
usual care plus NCI website
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27559, United States
Related Publications (2)
Ma C, Adler RH, Neidre DB, Chen RC, Northouse LL, Rini C, Tan X, Song L. Challenges and Approaches to Recruitment for and Retention in a Dyad-Focused eHealth Intervention During COVID-19: Randomized Controlled Trial. J Med Internet Res. 2024 Dec 3;26:e51877. doi: 10.2196/51877.
PMID: 39625741DERIVEDSong 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.
PMID: 34983621DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
1\) North Carolina experienced extreme weather events, including storms and flooding (2018, 2019, and 2022), Hurricanes Florence (Category 4, 2018) and Isaias (Category 1, 2020), and Tropical Storm Michael (2018); 2) the control group was exposed to an improved standard of care as the NCI website became substantially more interactive, user-friendly, and sophisticated; 3) the COVID-19 brought ubiquitous online communication and mental distress. All might have affected the study outcomes.
Results Point of Contact
- Title
- Xianming Tan, PhD
- Organization
- University of North Carolina Lineberger Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Lixin (Lee) Song, RN, PhD
University of North Carolina, Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The investigator and data collectors will be masked to intervention.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2018
First Posted
April 5, 2018
Study Start
May 30, 2018
Primary Completion
July 6, 2022
Study Completion
July 31, 2022
Last Updated
October 3, 2024
Results First Posted
October 3, 2024
Record last verified: 2024-09