Prostate Cancer Clinical Trial

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

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).

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Full 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.

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Eligibility Criteria

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 is for people with:

Prostate Cancer

Estimated Enrollment:

560

Study ID:

NCT03489057

Recruitment Status:

Completed

Sponsor:

UNC Lineberger Comprehensive Cancer Center

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There is 1 Location for this study

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University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27559, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

560

Study ID:

NCT03489057

Recruitment Status:

Completed

Sponsor:


UNC Lineberger Comprehensive Cancer Center

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