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

N

National Taipei University of Nursing and Health Sciences

Status

Not yet enrolling

Conditions

Prostate Cancer (Adenocarcinoma)

Treatments

Other: Dyadic Co-learning Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT07196488
202202198B0C1002

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Control Group
No Intervention group
Description:
Participants in the control group will receive routine care.
Dyadic Co-learning Intervention Group
Experimental group
Description:
Participants in the experimental group will receive routine care plus an 8-week Dyadic Co-learning Intervention.
Treatment:
Other: Dyadic Co-learning Intervention

Trial contacts and locations

0

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Central trial contact

Ching-Hui Chien, PhD

Data sourced from clinicaltrials.gov

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