Dyadic Co-learning Intervention for Patients With Prostate Cancer and Their Spouses
NCT ID: NCT07196488
Last Updated: 2025-09-29
Study Results
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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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-09-16
2026-07-31
Brief Summary
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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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Control Group
Participants in the control group will receive routine care.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
1. Diagnosed with another type of cancer.
2. Diagnosed with cognitive impairment or a psychiatric disorder, such as dementia, depression, or anxiety.
20 Years
90 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
National Taipei University of Nursing and Health Sciences
OTHER
Responsible Party
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Ching-Hui Chien
RN, PhD, Professor
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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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.
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.
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.
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.
Other Identifiers
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202202198B0C1002
Identifier Type: -
Identifier Source: org_study_id
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