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

NCT03489057 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2024-10-03

Study results available
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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).

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Lixin (Lee) Song, RN, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-30
Primary Completion
2022-07-06
Completion
2022-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03489057 on ClinicalTrials.gov