Clinical trial NCT03489057: Efficacy of a Couple-Focused mHealth Symptom Self-management Program
Official title: Testing the Efficacy of a Couple-Focused, Tailored mHealth Intervention for Symptom Self-Management Among Men With Prostate Cancer and Their Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: symptom
family research
self-management
caregiving
social support
mHealth
healthy behavior
self-efficacy
quality of life
care transition
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-04-05
Enrollment: 560
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Quality of Life Over Time as Assessed by Functional Assessment of Cancer Treatment (FACT-G) Scores
timeFrame: Baseline, month 4, 8 and 12
Secondary outcomes:
measure: Change in Pain From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by Patient-Reported Outcome Measurement Information System (PROMIS) Scores
timeFrame: Baseline, month 4, 8, and 12
measure: 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
timeFrame: Baseline, month 4, 8, and 12
measure: Change in Sleep Disturbance From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS Scores
timeFrame: Baseline, month 4, 8, and 12
measure: Change in Anxiety From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Emotional Distress-Anxiety Short Form
timeFrame: Baseline, month 4, 8, and 12
measure: Change in Depression From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Emotional Distress-Depression
timeFrame: Baseline, month 4, 8, and 12
measure: Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Urinary Symptom Score (Patient Only)
timeFrame: Baseline, month 4, 8, and 12
measure: Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Bowel Symptom Score (Patient Only)
timeFrame: Baseline, month 4, 8, and 12
measure: Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Sexual Symptom Score (Patients Only)
timeFrame: Baseline, month 4, 8, and 12
measure: Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Hormonal Symptom Score (Patient Only)
timeFrame: Baseline, month 4, 8, and 12
measure: Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Urine Symptom Score (Partners Only)
timeFrame: Baseline, month 4, 8, and 12
measure: Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Bowel Symptom (Partners Only)
timeFrame: Baseline, month 4, 8, and 12
measure: Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Hormonal Symptom Score Partners Only)
timeFrame: Baseline, month 4, 8, and 12
measure: Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Sexual Symptom Score Partners Only)
timeFrame: Baseline, month 4, 8, and 12
measure: Change in Self-efficacy Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by the Lewis Cancer Self-Efficacy Scale
timeFrame: Baseline, month 4, 8, and 12
measure: Change in Informational Support Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Informational Support Short Form
timeFrame: Baseline, month 4, 8, and 12
measure: Change in Instrumental Support Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Measured by PROMIS Instrumental Support-Short Form 8a
timeFrame: Baseline, month 4, 8, and 12
measure: Change in Appraisal of Illness Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Measured by Appraisal of Illness Scale
timeFrame: Baseline, month 4, 8, and 12
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Lixin (Lee) Song, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.