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

NCT ID: NCT07196488

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-16

Study Completion Date

2026-07-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer (Adenocarcinoma)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control Group

Participants in the control group will receive routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Dyadic Co-learning Intervention Group

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

Group Type EXPERIMENTAL

Dyadic Co-learning Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

For Patients:

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

For Spouses:

1. Must be a cohabiting spouse of the prostate cancer patient and aged 20 years or older.
2. 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:

1. Diagnosed with another type of cancer.
2. Diagnosed with cognitive impairment or a psychiatric disorder, such as dementia, depression, or anxiety.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role collaborator

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ching-Hui Chien

RN, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ching-Hui Chien

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

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Ching-Hui Chien, PhD

Role: CONTACT

+886-2-28227101 ext. 3103

References

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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.

Reference Type BACKGROUND
PMID: 16824985 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20350762 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35195282 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31214071 (View on PubMed)

Other Identifiers

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202202198B0C1002

Identifier Type: -

Identifier Source: org_study_id

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