Dyadic Co-learning Intervention for Patients With Prostate Cancer and Their Spouses

Official title

Development and Exploring the Efficacy of a Dyadic Co-learning Intervention for Patients With Prostate Cancer and Their Spouses

Overview

This study aims to help patients with prostate cancer and their spouses cope better with the challenges of cancer by learning and supporting each other together. The investigators will test an 8-week "Dyadic Co-learning Intervention," which includes weekly learning topics, a mobile app, and professional support. The goal is to improve their physical symptoms, emotional well-being, and resilience. Participants will be randomly assigned to one of two groups. One group will receive regular care, while the other group will receive regular care plus the new co-learning program. The investigators will ask both patients and their spouses to complete questionnaires at the beginning of the study, and again at 10 and 16 weeks, to understand how the program affects their health and well-being.

Detailed description

Objective:

To evaluate the effectiveness of a Dyadic Co-learning Intervention for patients with prostate cancer and their spouses, focusing on physical symptoms, emotional well-being, and resilience.

Study Design:

An experimental, two-group, randomized controlled design will be adopted. Participants will be recruited through convenience sampling from the urology outpatient department and inpatient wards of a hospital. Patients diagnosed with prostate cancer and their cohabiting spouses who agree to participate will provide written informed consent prior to data collection.

Procedures:

Baseline data (Time 0) will be collected using structured questionnaires. After completing the pretest assessment, patient-spouse dyads will be randomly assigned to either the intervention group or the control group in a 1:1 ratio.

The intervention group will receive routine care plus an 8-week Dyadic Co-learning Intervention, while the control group will receive routine care only.

Follow-up assessments will be conducted at the 10th week (Time 1) and the 16th week (Time 2) after the baseline to evaluate intervention outcomes.

Interventions

• Other Dyadic Co-learning Intervention
  Participants in the experimental group will receive routine care plus an 8-week Dyadic Co-learning Intervention, which will consist of three components: (1) a co-learning handbook, (2) a co-learning mobile app, and (3) professional support.

Primary outcome measures

• Family Resilience (patients and spouses) [Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test]

Secondary outcome measures (6)

• Physical Symptoms and Distress (patients only) [Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test]
• Fatigue (patients only) [Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test]
• Resilience (patients and spouses) [Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test]
• Loneliness (patients and spouses) [Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test]
• Subjective Well-Being (patients and spouses) [Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test]
• Intervention Satisfaction (patients and spouses in intervention group) [Time frame: 10th weeks after the pre-test]

Eligibility criteria

Inclusion criteria

For Patients:

• Diagnosed with prostate cancer by a board-certified urologist.
• Has either decided on a treatment plan or completed treatment within the past two years.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

For Spouses:

• Must be a cohabiting spouse of the prostate cancer patient and aged 20 years or older.
• Must have a Barthel Index score of 91 or above, indicating good functional independence.

Exclusion criteria

Either the patient or the spouse will be excluded if:

• Diagnosed with another type of cancer.
• Diagnosed with cognitive impairment or a psychiatric disorder, such as dementia, depression, or anxiety.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Taiwan · 2 centers

• Keelung Chang Gung Memorial Hospital — Keelung
• LinKou Chang Gung Memorial Hospital — Taoyuan

Publications

• Lin CC, Chang AP, Chen ML, Cleeland CS, Mendoza TR, Wang XS. Validation of the Taiwanese version of the Brief Fatigue Inventory. J Pain Symptom Manage. 2006 Jul;32(1):52-9. doi: 10.1016/j.jpainsymman.2005.12.019. PMID 16824985
• Szymanski KM, Wei JT, Dunn RL, Sanda MG. Development and validation of an abbreviated version of the expanded prostate cancer index composite instrument for measuring health-related quality of life among prostate cancer survivors. Urology. 2010 Nov;76(5):1245-50. doi: 10.1016/j.urology.2010.01.027. Epub 2010 Mar 28. PMID 20350762
• Wang A, Lu J. Validation of the Chinese version of the Walsh Family Resilience Questionnaire. Fam Process. 2023 Mar;62(1):368-386. doi: 10.1111/famp.12751. Epub 2022 Feb 23. PMID 35195282
• Meng M, He J, Guan Y, Zhao H, Yi J, Yao S, Li L. Factorial Invariance of the 10-Item Connor-Davidson Resilience Scale Across Gender Among Chinese Elders. Front Psychol. 2019 May 31;10:1237. doi: 10.3389/fpsyg.2019.01237. eCollection 2019. PMID 31214071
• Chien CH, Chuang CK, Wu CT, Pang ST, Yu KJ, Lin PH, Liu KL. Theory-based dyadic co-learning intervention to enhance family resilience in men with prostate cancer and their spouses in Taiwan: protocol for a randomised controlled trial. BMJ Open. 2026 Jun 28;16(6):e118902. doi: 10.1136/bmjopen-2026-118902. PMID 42366001

Identifiers

NCT: NCT07196488 · 202202198B0C1002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗