N/A
Completed N=560
Efficacy of a Couple-Focused mHealth Symptom Self-management Program
Source: ClinicalTrials.gov NCT03489057 ↗Enrolled (actual)
560
Serious AEs
1.4%
Results posted
Oct 2024
Primary outcomePrimary: Change in Quality of Life Over Time as Assessed by Functional Assessment of Cancer Treatment (FACT-G) Scores — 89.48; 90.54; 90.29; 90.42 score on a scale — p=0.19
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quality of Life Over Time as Assessed by Functional Assessment of Cancer Treatment (FACT-G) Scores |
89.48; 90.54; 90.29; 90.42; 88.38; 90.18 | 0.19 |
| SECONDARY Change in Pain From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by Patient-Reported Outcome Measurement Information System (PROMIS) Scores |
48.88; 48.38; 49.25; 48.37; 49.68; 48.53 | — |
| SECONDARY 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 |
46.99; 45.78; 47.02; 45.77; 48.44; 47.38 | — |
| SECONDARY Change in Sleep Disturbance From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS Scores |
48.82; 48.54; 48.58; 47.43; 49.96; 50.08 | — |
| SECONDARY Change in Anxiety From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Emotional Distress-Anxiety Short Form |
45.15; 44.46; 44.32; 44.11; 46.09; 48.04 | — |
| SECONDARY Change in Depression From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Emotional Distress-Depression |
56.50; 56.31; 57.28; 56.54; 56.92; 56.48 | — |
| SECONDARY Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Urinary Symptom Score (Patient Only) |
67.50; 79.25; 82.58; 80.62; 68.14; 79.23 | — |
| SECONDARY Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Bowel Symptom Score (Patient Only) |
91.90; 93.89; 94.20; 95.23; 90.03; 93.23 | — |
| SECONDARY Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Sexual Symptom Score (Patients Only) |
22.96; 24.98; 27.65; 28.20; 21.51; 27.40 | — |
| SECONDARY Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Hormonal Symptom Score (Patient Only) |
87.57; 85.24; 86.69; 89.41; 85.62; 87.44 | — |
| SECONDARY Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Urine Symptom Score (Partners Only) |
76.95; 86.03; 90.44; 86.88; 78.60; 87.62 | — |
| SECONDARY Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Bowel Symptom (Partners Only) |
91.13; 96.78; 97.79; 95.00; 92.45; 96.00 | — |
| SECONDARY Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Hormonal Symptom Score Partners Only) |
76.42; 77.23; 73.53; 75.31; 76.98; 73.75 | — |
| SECONDARY Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Sexual Symptom Score Partners Only) |
65.11; 66.16; 64.06; 61.56; 63.22; 60.86 | — |
| SECONDARY Change in Self-efficacy Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by the Lewis Cancer Self-Efficacy Scale |
0.48; -0.75; -0.90; -0.76; -1.00; -1.94 | 0.48 |
| SECONDARY Change in Informational Support Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Informational Support Short Form |
57.24; 57.29; 58.27; 57.52; 57.07; 57.02 | — |
| SECONDARY Change in Instrumental Support Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Measured by PROMIS Instrumental Support-Short Form 8a |
60.38; 60.59; 60.30; 61.22; 60.81; 60.78 | — |
| SECONDARY Change in Appraisal of Illness Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Measured by Appraisal of Illness Scale |
3.73; 3.86; 3.83; 3.95; 3.81; 3.86 | — |
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).
Data sourced from ClinicalTrials.gov (NCT03489057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.