Prostate Cancer (Adenocarcinoma)NCT07196488
Dyadic Co-learning Intervention for Patients With Prostate Cancer and Their Spouses
A study testing Dyadic Co-learning Intervention in people with Prostate Cancer (Adenocarcinoma), run by National Taipei University of Nursing and Health Sciences at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- Dyadic Co-learning Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 13 Oct 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Not yet recruiting
Keelung Chang Gung Memorial Hospital
Keelung
Kuanlin Liu, +886-2-24313131, kuanlin@cgmh.org.tw
- Recruiting
LinKou Chang Gung Memorial Hospital
Taoyuan, 333
Kuanlin Liu, +886-2-24313131, kuanlin@cgmh.org.tw
About this study
Official title: Development and Exploring the Efficacy of a 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.
Read the detailed 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.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Being tested
- Dyadic Co-learning Intervention
- Keywords
- Prostate cancer, emotional well-being, physical symptoms
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic Co-learning InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Dyadic Co-learning Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
Fatigue (patients only)
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.
Measured: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
Resilience (patients and spouses)
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.
Measured: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
Loneliness (patients and spouses)
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.
Measured: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
Subjective Well-Being (patients and spouses)
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.
Measured: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
Intervention Satisfaction (patients and spouses in intervention group)
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.
Measured: 10th weeks after the pre-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start13 Oct 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Principal investigator, Ching-Hui Chien, National Taipei University of Nursing and Health Sciences
- Investigators
- Ching-Hui Chien, Principal investigator, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196488
- Sponsor's protocol ID
- 202202198B0C1002
- Status last verified
- May 2026
- First submitted
- 6 Sep 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data supporting this study's findings are available from the corresponding author upon reasonable request. The data are not publicly available due to the consideration of ethics, the researchers shall maintain the privacy of the participants, and research data should be used only for academic articles.
Publications
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.
PubMed 16824985Szymanski 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.
PubMed 20350762Wang 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.
PubMed 35195282Meng 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.
PubMed 31214071Chien CH, Chuang CK, Wu CT, Pang ST, Yu KJ, Lin PH, Liu KL. Theory-based dyadic co-learning intervention to enhance family resilience in men with prostate cancer and their spouses in Taiwan: protocol for a randomised controlled trial. BMJ Open. 2026 Jun 28;16(6):e118902. doi: 10.1136/bmjopen-2026-118902.
PubMed 42366001
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Exploring the Efficacy of a Dyadic Co-learning Intervention for Patients With Prostate Cancer and Their Spouses
- ClinicalTrials.gov ID
- NCT07196488
- Acronym / sponsor ID
- 202202198B0C1002
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- Prostate cancer, emotional well-being, physical symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants in the control group will receive routine care. |
| Dyadic Co-learning Intervention Group | Experimental | Other: Dyadic Co-learning InterventionParticipants in the experimental group will receive routine care plus an 8-week Dyadic Co-learning Intervention. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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.
Key exclusion criteria (3 listed)
- Diagnosed with another type of cancer.
- Diagnosed with cognitive impairment or a psychiatric disorder, such as dementia, depression, or anxiety.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic Co-learning InterventionParticipants 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. | Other | Dyadic Co-learning Intervention Group |
Primary outcome
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.
6 secondary outcomes
Physical Symptoms and Distress (patients only)
Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
Fatigue (patients only)
Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
Resilience (patients and spouses)
Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
Loneliness (patients and spouses)
Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
Subjective Well-Being (patients and spouses)
Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
Intervention Satisfaction (patients and spouses in intervention group)
Time frame: 10th weeks after the pre-test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Background: PubMed 16824985Lin 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.
- Background: PubMed 20350762Szymanski 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.
- Background: PubMed 35195282Wang 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.
- Background: PubMed 31214071Meng 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.
- Derived from this study: PubMed 42366001Chien CH, Chuang CK, Wu CT, Pang ST, Yu KJ, Lin PH, Liu KL. Theory-based dyadic co-learning intervention to enhance family resilience in men with prostate cancer and their spouses in Taiwan: protocol for a randomised controlled trial. BMJ Open. 2026 Jun 28;16(6):e118902. doi: 10.1136/bmjopen-2026-118902.
- Individual participant dataSharing planned: No. Data supporting this study's findings are available from the corresponding author upon reasonable request. The data are not publicly available due to the consideration of ethics, the researchers shall maintain the privacy of the participants, and research data should be used only for academic articles.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ching-Hui Chien principal investigator
National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic Co-learning Intervention in people with Prostate Cancer (Adenocarcinoma), run by National Taipei University of Nursing and Health Sciences at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ching-Hui Chien, PhD (+886-2-28227101 ext. 3103, chinghui@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Resilience (patients and spouses) (time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07196488, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.