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

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Prostate Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03489057

LCCC 1713

1R01NR016990-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

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.

Enrollment: 560 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

560 participants in 2 patient groups

PERC Program

Experimental group

Description:

Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to experimental condition will receive access to the PERC website.

Treatment:

Behavioral: Prostate Cancer Education and Resources for Couples (PERC)

usual care plus NCI website

Active Comparator group

Description:

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.

Treatment:

Behavioral: usual care plus NCI website