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NCT Number: NCT07196488

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

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.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keelung Chang Gung Memorial Hospital, Keelung, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Family Resilience (patients and spouses)

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

    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.

Secondary outcomes

  1. Physical Symptoms and Distress (patients only)

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

    This study will use the Chinese version of the Expanded Prostate Cancer Index Composite (EPIC-26) to assess symptoms and related distress in patients with prostate cancer. The scale consists of 26 items covering four domains: urinary incontinence, urinary irritation/obstruction, bowel symptoms and distress, sexual function and distress, and vitality/hormonal function and distress. Total scores range from 0 to 100, which higher scores indicate fewer symptoms and less distress.

  2. Fatigue (patients only)

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

    The Taiwanese version of the Brief Fatigue Inventory (BFI) will be used to assess the severity of cancer-related fatigue over the past 24 hours and its impact on daily life in patients with prostate cancer. The instrument consists of 9 items; each rated on an 11-point scale ranging from 0 to 10. Higher scores indicate greater fatigue severity or greater interference with daily activities.

  3. Resilience (patients and spouses)

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

    he 10-item version of the Connor-Davidson Resilience Scale (CD-RISC-10) will be used to measure individual resilience among both prostate cancer patients and their spouses. Each item is scored on a scale from 0 to 4, with total scores ranging from 0 to 40. Higher scores indicate greater resilience.

  4. Loneliness (patients and spouses)

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

    The Chinese version of the Loneliness Scale will be used to assess the level of loneliness in both prostate cancer patients and their spouses. The scale consists of 9 items, covering two subscales: social loneliness and emotional loneliness. Each item is scored dichotomously (0 or 1), with total scores ranging from 0 to 9. Higher scores indicate a greater sense of loneliness.

  5. Subjective Well-Being (patients and spouses)

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

    The Chinese Happiness Inventory, developed specifically for Chinese populations, will be used to measure subjective well-being among patients and their spouses. The scale includes 10 items rated on a 4-point scale (0-3), with total scores ranging from 0 to 30. Higher scores indicate greater perceived well-being.

  6. Intervention Satisfaction (patients and spouses in intervention group)

    Time frame: 10th weeks after the pre-test

    This questionnaire consists of five items designed to assess participants' satisfaction with the intervention program, including the mobile application, multimedia videos, handbook, and professional support. Each item will be scored on a scale from 0 to 100, with higher scores indicating greater satisfaction.

Other outcomes

  1. Age (Patients and Spouses)

    Time frame: Before the intervention (pre-test)

    The demographic information form will be used to collect the ages of patients and their spouses; a higher value indicates older age.

  2. Education level (Patients and Spouses)

    Time frame: Before the intervention (pre-test)

    The demographic information form will be used to collect the education levels of patients and their spouses, categorized as: elementary school, junior high school, senior high school, college/university, and graduate degree.

  3. Religious belief (Patients and Spouses)

    Time frame: Before the intervention (pre-test)

    The demographic information form will be used to collect the religious belief of patients and their spouses, categorized as: None, Buddhism, Taoism, Christianity, Catholicism, folk religion, and others.

  4. Employment status (Patients and Spouses)

    Time frame: Before the intervention (pre-test)

    The demographic information form will be used to collect the employment status of patients and their spouses, categorized as: full-time employed, part-time employed, on medical leave (retaining employment), retired, unemployed, or other.

  5. Number of children (Patients and Spouses)

    Time frame: Before the intervention (pre-test)

    The demographic information form will be used to collect the ages of patients and their spouses; categorized as none, or number of sons and daughters (self-reported).

  6. Relationship status (Patients and Spouses)

    Time frame: Before the intervention (pre-test)

    The demographic information form will be used to collect the relationship status of patients and their spouses, categorized as married, single/never married, divorced, widowed, cohabiting, or remarried.

  7. Living arrangement (Patients)

    Time frame: Before the intervention (pre-test)

    The demographic information form will be used to collect the living arrangement of patients, categorized as living alone, living with spouse, living with spouse and children, living with spouse and grandchildren, living with grandchildren, or other.

  8. Cancer stage (Patients)

    Time frame: Before the intervention (pre-test)

    The disease-related information form will be used to collect the cancer stage of patients.

  9. Time since diagnosis (Patients)

    Time frame: Before the intervention (pre-test)

    The disease-related information form will be used to collect the time since diagnosis (in months) of patients.

  10. Most recent PSA level (ng/mL) (Patients)

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

    The disease-related information form will be used to collect the most recent PSA level (ng/mL) of patients.

  11. Initial PSA level (ng/mL) (Patients)

    Time frame: Before the intervention (pre-test)

    The disease-related information form will be used to collect the initial PSA level (ng/mL) of patients.

  12. Gleason score (Patients)

    Time frame: Before the intervention (pre-test)

    The disease-related information form will be used to collect the gleason score of patients.

  13. Primary treatment method (Patients)

    Time frame: Before the intervention (pre-test)

    Primary treatment method for prostate cancer will be collected using the disease-related information form.

  14. History of cancer recurrence (Patients)

    Time frame: Before the intervention (pre-test)

    The disease-related information form will be used to collect the history of cancer recurrence among patients.

  15. Chronic disease history (Patients and Spouses)

    Time frame: Before the intervention (pre-test)

    Presence of comorbidities, assessed using the disease-related information form; categorized as none, or specified conditions (diabetes mellitus, asthma, gastrointestinal ulcer, glaucoma, hypertension, bronchitis, gastroesophageal reflux disease, cataract, heart disease, stroke, arthritis/degenerative joint disease, or other).

  16. Perceived physical health status (Patients and Spouses)

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

    The disease-related information form will be used to collect the perceived physical health status of patients and their spouses, with higher scores indicating better perceived physical health.

  17. Menopausal status (Spouses)

    Time frame: Before the intervention (pre-test)

    Menopausal status (irregular menstruation but not complete cessation), assessed using the disease-related information form; categorized as yes/no.

  18. History of menopause (Spouses)

    Time frame: Before the intervention (pre-test)

    History of menopause, assessed using the disease-related information form; categorized as yes/no. For participants who responded "yes," the age at menopause (in years) will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Ching-Hui Chien, PhD

CONTACT

[email protected]

+886-2-28227101 ext. 3103

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Collaborators

  • Chang Gung Memorial Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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