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

NCT07196488 | Recruiting

• 1 other identifier: 202202198B0C1002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

Prostate cancer; emotional well-being; physical symptoms

Outcome Measures

Primary Outcomes (1)

• Family Resilience (patients and spouses)

  This study will adopt the Chinese version of the Walsh Family Resilience Questionnaire to assess family resilience in patients with prostate cancer and their spouses. The scale uses a 5-point Likert rating, ranging from 1 (Never) to 5 (Always). Total scores range from 26 to 130, with higher scores indicating greater levels of family resilience.

  Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test

Secondary Outcomes (6)

• Physical Symptoms and Distress (patients only)

  Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test

• Fatigue (patients only)

  Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test

• Resilience (patients and spouses)

  Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test

• Loneliness (patients and spouses)

  Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test

• Subjective Well-Being (patients and spouses)

  Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test

Other Outcomes (18)

• Age (Patients and Spouses)

  Before the intervention (pre-test)

• Education level (Patients and Spouses)

  Before the intervention (pre-test)

• Religious belief (Patients and Spouses)

  Before the intervention (pre-test)

Study Arms (2)

Control Group

NO INTERVENTION

Participants in the control group will receive routine care.

Dyadic Co-learning Intervention Group

EXPERIMENTAL

Participants in the experimental group will receive routine care plus an 8-week Dyadic Co-learning Intervention.

Other: Dyadic Co-learning Intervention

Interventions

Dyadic Co-learning Intervention OTHER

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.

Dyadic Co-learning Intervention Group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: collaborator
• National Taipei University of Nursing and Health Sciences: lead

Study Sites (2)

Keelung Chang Gung Memorial Hospital

Keelung, Taiwan

NOT YET RECRUITING

LinKou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Ching-Hui Chien

  National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching-Hui Chien, PhD

CONTACT

+886-2-28227101; chinghui@ntunhs.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD, Professor

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 29, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)