Clinical trial · Interventional
Efficacy of a Couple-Focused mHealth Symptom Self-management Program
Testing the Efficacy of a Couple-Focused, Tailored mHealth Intervention for Symptom Self-Management Among Men With Prostate Cancer and Their Partners
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate Cancer Education and Resources for Couples (PERC) | Behavioral | — | UNRESOLVED |
| usual care plus NCI website | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PERC Program
- description
- Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to experimental condition will receive access to the PERC website.
- interventionNames
- Behavioral: Prostate Cancer Education and Resources for Couples (PERC)
- type
- ACTIVE_COMPARATOR
- label
- usual care plus NCI website
- 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.
- interventionNames
- Behavioral: usual care plus NCI website
Primary outcomes (1)
- measure
- Change in Quality of Life Over Time as Assessed by Functional Assessment of Cancer Treatment (FACT-G) Scores
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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).
References
Publications (2)
- DERIVEDMa C, Adler RH, Neidre DB, Chen RC, Northouse LL, Rini C, Tan X, Song L. Challenges and Approaches to Recruitment for and Retention in a Dyad-Focused eHealth Intervention During COVID-19: Randomized Controlled Trial. J Med Internet Res. 2024 Dec 3;26:e51877. doi: 10.2196/51877. PMID 39625741
- DERIVEDSong 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. PMID 34983621