Prostatic NeoplasmsNCT05335967

Effectiveness Evaluation of a Self-management Program for Prostate Cancer Survivors

A study testing Self-management program and Information package in people with Prostatic Neoplasms and Self-Management, run by National Taipei University of Nursing and Health Sciences at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Objectives: This project aims to develop a self-management program for survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy and determine its effectiveness. Read more about this study

Who is it for?: Ages 20 to 80 years, men only
Conditions the study is for: Prostatic Neoplasms, Self-Management
What is being tested?: Self-management program and Information package
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 2 sitesTaiwan
Study dates: 20 May 2022to 31 Jul 2024
Phase: Interventional
Are there results?: None posted in the registry

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 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Prostate cancer survivors will include if they fit the following:
Received radical prostatectomy and suffering from urinary incontinence for at least one week
Eastern Cooperative Oncology Group 0-1 point, able to walk entirely independently
Have a smartphone or a tablet with a wireless network
Their intimate partner or one of the family members willing to learn together
Agreed to participate in the study and completed the informed consent form

Who cannot join

Prostate cancer survivors will be excluded if they had one or more of the following:
A request, with the consideration of family members, that the medical team not tell the patient about the diagnosis or condition of the disease
A history of psychiatric illness, such as dementia, depression; schizophrenia, or bipolar disorder
Suffer from other types of cancer and actively undergoing treatment

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

Chang Gung Memorial Hospital at Keelung
Keelung
Chang Gung Memorial Hospital at Linkou
Taoyuan, 33305

Other trials in Taiwan

About this study

Official title: Development and Effectiveness Evaluation of a Self-management Program for Prostate Cancer Survivors

Read the detailed description

Methods: The investigators will develop a self-management program and conduct a study on survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy. And the investigators will test the effectiveness of the self-management program. After completing a pretest, participants will be randomly assigned to the experimental or control group. The self-management group will receive the self-management program for 12 weeks, whereas the information group will receive an information package on a healthy diet. The self-management program is included a self-management application, a self-management manual, and professional support. The information package consists of a manual on a healthy diet and a multimedia film on a healthy diet. Posttests will be administered 12 and 16 weeks after the pretest. The study variables will include physical symptoms and bothers, cancer-related self-efficacy, social participation, demoralization, and resilience. The statistical analyses will consist of independent sample t-tests, Chi-squire, and generalized estimating equation analysis.

Conditions: Prostatic Neoplasms, Self-Management
Being tested: Self-management program, Information package
Keywords: Prostate cancer, Self-Management, Social participation, Resilience, Rear of cancer recurrence, Self-efficacy, Demoralization
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Self-management programBehavioural
The self-management group will receive the self-management program for 12 weeks, including a self-management application, a self-management manual, and Professional support.
Information packageOther
The patients in this group will receive an information package on a healthy diet.

Study groups in NCT05335967
Study group	Role	What they receive
Self-management group	Experimental	The experimental group will receive the self-management program for 12 weeks. Receives: Behavioral: Self-management program
Information group	Other	The control group will receive an information package on a healthy diet. Receives: Other: Information package

What is being measured

The primary outcome is the main question the study is designed to answer.

Cancer related self-efficacy
The Mandarin version of the Cancer Survivors' Self-Efficacy Scale (CSSES) will be used to evaluate the cancer-specific self-efficacy of participants.The total score ranges from 11 to 110; the lower the score, the worse the self-efficacy.
Measured: Pre-test
Cancer related self-efficacy
The Mandarin version of the Cancer Survivors' Self-Efficacy Scale (CSSES) will be used to evaluate the cancer-specific self-efficacy of participants.The total score ranges from 11 to 110; the lower the score, the worse the self-efficacy.
Measured: 12 weeks after the pretest
Cancer related self-efficacy
The Mandarin version of the Cancer Survivors' Self-Efficacy Scale (CSSES) will be used to evaluate the cancer-specific self-efficacy of participants.The total score ranges from 11 to 110; the lower the score, the worse the self-efficacy.
Measured: 16 weeks after the pretest

Secondary outcomes (12)

Urinary symptoms and bothers
The Mandarin version of the Expanded Prostate Cancer Index Composite (EPIC) will be used to measure the urinary symptoms and bother of the participants. Total 7 items and each question is linearly scaled from 0 (worst) to 100 (best).
Measured: Pre-test
Urinary symptoms and bothers
The Mandarin version of the Expanded Prostate Cancer Index Composite (EPIC) will be used to measure the urinary symptoms and bother of the participants. Total 7 items and each question is linearly scaled from 0 (worst) to 100 (best).
Measured: 12 weeks after the pretest
Urinary symptoms and bothers
The Mandarin version of the Expanded Prostate Cancer Index Composite (EPIC) will be used to measure the urinary symptoms and bother of the participants. Total 7 items and each question is linearly scaled from 0 (worst) to 100 (best).
Measured: 16 weeks after the pretest
Social participation
1. The Mandarin version of the Older Adults Social Participation Scale will be used to assess participants' social participation. The scale includes 12 items with a score range of 12 to 60. A higher score shows a higher degree of social participation.
2. Self-designed items will be used to assess participants' willingness to participate in social activities (1 item) and their satisfaction with social activities (1 item). Each item will have a score range of 0 to 10, with higher scores indicating a greater willingness to participate or higher satisfaction.
Measured: Pre-test
Social participation
1. The Mandarin version of the Older Adults Social Participation Scale will be used to assess participants' social participation. The scale includes 12 items with a score range of 12 to 60. A higher score shows a higher degree of social participation.
2. Self-designed items will be used to assess participants' willingness to participate in social activities (1 item) and their satisfaction with social activities (1 item). Each item will have a score range of 0 to 10, with higher scores indicating a greater willingness to participate or higher satisfaction.
Measured: 12 weeks after the pretest
Social participation
1. The Mandarin version of the Older Adults Social Participation Scale will be used to assess participants' social participation. The scale includes 12 items with a score range of 12 to 60. A higher score shows a higher degree of social participation.
2. Self-designed items will be used to assess participants' willingness to participate in social activities (1 item) and their satisfaction with social activities (1 item). Each item will have a score range of 0 to 10, with higher scores indicating a greater willingness to participate or higher satisfaction.
Measured: 16 weeks after the pretest
Demoralization
The Mandarin version of the Demoralization Scale will be used to assess participants' demoralization. The scale includes 24 items, and the score range is 0-96. A higher score means higher demoralization.
Measured: Pre-test
Demoralization
The Mandarin version of the Demoralization Scale will be used to assess participants' demoralization. The scale includes 24 items, and the score range is 0-96. A higher score means higher demoralization.
Measured: 12 weeks after the pretest
Demoralization
The Mandarin version of the Demoralization Scale will be used to assess participants' demoralization. The scale includes 24 items, and the score range is 0-96. A higher score means higher demoralization.
Measured: 16 weeks after the pretest
Resilience
The Mandarin version of the Connor-Davidson Resilience Scale will be used to measure the psychological resilience of participants. The scale has 10 items, and the score range is 0-100. A higher score reflects better resilience.
Measured: Pre-test
Resilience
The Mandarin version of the Connor-Davidson Resilience Scale will be used to measure the psychological resilience of participants. The scale has 10 items, and the score range is 0-100. A higher score reflects better resilience.
Measured: 12 weeks after the pretest
Resilience
The Mandarin version of the Connor-Davidson Resilience Scale will be used to measure the psychological resilience of participants. The scale has 10 items, and the score range is 0-100. A higher score reflects better resilience.
Measured: 16 weeks after the pretest

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 202231 Jul 2024

First posted20 Apr 2022
Study start20 May 2022
Primary completion31 Jul 2024
Study completion31 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Prostatic NeoplasmsStudies 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: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05335967
Sponsor's protocol ID: 201902235B0C601
Status last verified: Sep 2023
First submitted: 4 Apr 2022
Last updated: 3 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chien CH, Liu KL, Wu CT, Chuang CK, Yu KJ, Lin PH, Huang XY, Pang ST. Development and assessment of a self-management intervention for urinary incontinence among patients with prostate cancer: protocol for a randomized feasibility study. BMC Urol. 2023 Nov 18;23(1):193. doi: 10.1186/s12894-023-01367-7.
PubMed 37980490
Agochukwu NQ, Skolarus TA, Wittmann D. Telemedicine and prostate cancer survivorship: a narrative review. Mhealth. 2018 Oct 8;4:45. doi: 10.21037/mhealth.2018.09.08. eCollection 2018.
PubMed 30505843
An E, Lo C, Hales S, Zimmermann C, Rodin G. Demoralization and death anxiety in advanced cancer. Psychooncology. 2018 Nov;27(11):2566-2572. doi: 10.1002/pon.4843. Epub 2018 Aug 20.
PubMed 30053317
Baker H, Wellman S, Lavender V. Functional Quality-of-Life Outcomes Reported by Men Treated for Localized Prostate Cancer: A Systematic Literature Review. Oncol Nurs Forum. 2016 Mar;43(2):199-218. doi: 10.1188/16.ONF.199-218.
PubMed 26906131
Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
PubMed 847061
Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.
PubMed 18157881
Chien CH, Chuang CK, Liu KL, Huang XY, Liu HE. Psychosocial adjustments in patients with prostate cancer from pre-diagnosis to 6 months post-treatment. Int J Nurs Pract. 2016 Feb;22(1):70-8. doi: 10.1111/ijn.12360. Epub 2014 Oct 13.
PubMed 25307968
Chien CH, Chung HJ, Liu KL, Pang ST, Wu CT, Chang YH, Huang XY, Chang YH, Lin TP, Lin WY, Chuang CK. Effectiveness of a couple-based psychosocial intervention on patients with prostate cancer and their partners: A quasi-experimental study. J Adv Nurs. 2020 Oct;76(10):2572-2585. doi: 10.1111/jan.14471. Epub 2020 Aug 3.
PubMed 32744426
Chou MC, Chien CH, Chung HJ, Chuang CK, Wu CT, Pang ST, Liu KL, Chang YH. The Psychometric Properties of Taiwanese Version of the Memorial Anxiety Scale for Prostate Cancer. J Pain Symptom Manage. 2021 Apr;61(4):824-830. doi: 10.1016/j.jpainsymman.2020.10.013. Epub 2020 Oct 24.
PubMed 33198956
Cockle-Hearne J, Faithfull S. Self-management for men surviving prostate cancer: a review of behavioural and psychosocial interventions to understand what strategies can work, for whom and in what circumstances. Psychooncology. 2010 Sep;19(9):909-22. doi: 10.1002/pon.1657.
PubMed 20119934
Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
PubMed 12964174
Crafoord MT, Fjell M, Sundberg K, Nilsson M, Langius-Eklof A. Engagement in an Interactive App for Symptom Self-Management during Treatment in Patients With Breast or Prostate Cancer: Mixed Methods Study. J Med Internet Res. 2020 Aug 10;22(8):e17058. doi: 10.2196/17058.
PubMed 32663140
Faithfull S, Cockle-Hearne J, Khoo V. Self-management after prostate cancer treatment: evaluating the feasibility of providing a cognitive and behavioural programme for lower urinary tract symptoms. BJU Int. 2011 Mar;107(5):783-790. doi: 10.1111/j.1464-410X.2010.09588.x. Epub 2010 Oct 13.
PubMed 20942826
Foster C, Breckons M, Cotterell P, Barbosa D, Calman L, Corner J, Fenlon D, Foster R, Grimmett C, Richardson A, Smith PW. Cancer survivors' self-efficacy to self-manage in the year following primary treatment. J Cancer Surviv. 2015 Mar;9(1):11-9. doi: 10.1007/s11764-014-0384-0. Epub 2014 Jul 16.
PubMed 25028218
Foster C, Fenlon D. Recovery and self-management support following primary cancer treatment. Br J Cancer. 2011 Nov 8;105 Suppl 1(Suppl 1):S21-8. doi: 10.1038/bjc.2011.419.
PubMed 22048029

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma

All Prostatic Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Effectiveness Evaluation of a Self-management Program for Prostate Cancer Survivors
ClinicalTrials.gov ID: NCT05335967
Acronym / sponsor ID: 201902235B0C601
Conditions: Prostatic Neoplasms, Self-Management
Keywords: Prostate cancer, Self-Management, Social participation, Resilience, Rear of cancer recurrence, Self-efficacy, Demoralization
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: National Taipei University of Nursing and Health SciencesUniversity, hospital or other
Collaborators: Chang Gung Memorial Hospital, National Science and Technology Council
Study start: 20 May 2022 (actual)
Primary completion: 31 Jul 2024 (actual)
Study completion: 31 Jul 2024 (actual)
First posted: 20 Apr 2022 (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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Self-management group	Experimental	Behavioral: Self-management programThe experimental group will receive the self-management program for 12 weeks.
Information group	Other	Other: Information packageThe control group will receive an information package on a healthy diet.

Who may qualify

Ages: 20 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Received radical prostatectomy and suffering from urinary incontinence for at least one week
Eastern Cooperative Oncology Group 0-1 point, able to walk entirely independently
Have a smartphone or a tablet with a wireless network
Their intimate partner or one of the family members willing to learn together
Agreed to participate in the study and completed the informed consent form

Key exclusion criteria (4 listed)

A request, with the consideration of family members, that the medical team not tell the patient about the diagnosis or condition of the disease
A history of psychiatric illness, such as dementia, depression; schizophrenia, or bipolar disorder
Suffer from other types of cancer and actively undergoing treatment

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
Self-management programThe self-management group will receive the self-management program for 12 weeks, including a self-management application, a self-management manual, and Professional support.	Behavioural	Self-management group
Information packageThe patients in this group will receive an information package on a healthy diet.	Other	Information group

Primary outcome

Cancer related self-efficacy
Time frame: Pre-test
The Mandarin version of the Cancer Survivors' Self-Efficacy Scale (CSSES) will be used to evaluate the cancer-specific self-efficacy of participants.The total score ranges from 11 to 110; the lower the score, the worse the self-efficacy.
Cancer related self-efficacy
Time frame: 12 weeks after the pretest
The Mandarin version of the Cancer Survivors' Self-Efficacy Scale (CSSES) will be used to evaluate the cancer-specific self-efficacy of participants.The total score ranges from 11 to 110; the lower the score, the worse the self-efficacy.
Cancer related self-efficacy
Time frame: 16 weeks after the pretest
The Mandarin version of the Cancer Survivors' Self-Efficacy Scale (CSSES) will be used to evaluate the cancer-specific self-efficacy of participants.The total score ranges from 11 to 110; the lower the score, the worse the self-efficacy.

12 secondary outcomes

Urinary symptoms and bothers
Time frame: Pre-test
Urinary symptoms and bothers
Time frame: 12 weeks after the pretest
Urinary symptoms and bothers
Time frame: 16 weeks after the pretest
Social participation
Time frame: Pre-test
Social participation
Time frame: 12 weeks after the pretest
Social participation
Time frame: 16 weeks after the pretest
Demoralization
Time frame: Pre-test
Demoralization
Time frame: 12 weeks after the pretest
Demoralization
Time frame: 16 weeks after the pretest
Resilience
Time frame: Pre-test
Resilience
Time frame: 12 weeks after the pretest
Resilience
Time frame: 16 weeks after the pretest

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
Background: PubMed 37980490Chien CH, Liu KL, Wu CT, Chuang CK, Yu KJ, Lin PH, Huang XY, Pang ST. Development and assessment of a self-management intervention for urinary incontinence among patients with prostate cancer: protocol for a randomized feasibility study. BMC Urol. 2023 Nov 18;23(1):193. doi: 10.1186/s12894-023-01367-7.
Background: PubMed 30505843Agochukwu NQ, Skolarus TA, Wittmann D. Telemedicine and prostate cancer survivorship: a narrative review. Mhealth. 2018 Oct 8;4:45. doi: 10.21037/mhealth.2018.09.08. eCollection 2018.
Background: PubMed 30053317An E, Lo C, Hales S, Zimmermann C, Rodin G. Demoralization and death anxiety in advanced cancer. Psychooncology. 2018 Nov;27(11):2566-2572. doi: 10.1002/pon.4843. Epub 2018 Aug 20.
Background: PubMed 26906131Baker H, Wellman S, Lavender V. Functional Quality-of-Life Outcomes Reported by Men Treated for Localized Prostate Cancer: A Systematic Literature Review. Oncol Nurs Forum. 2016 Mar;43(2):199-218. doi: 10.1188/16.ONF.199-218.
Background: PubMed 847061Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
Background: PubMed 18157881Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.
Background: PubMed 25307968Chien CH, Chuang CK, Liu KL, Huang XY, Liu HE. Psychosocial adjustments in patients with prostate cancer from pre-diagnosis to 6 months post-treatment. Int J Nurs Pract. 2016 Feb;22(1):70-8. doi: 10.1111/ijn.12360. Epub 2014 Oct 13.
Background: PubMed 32744426Chien CH, Chung HJ, Liu KL, Pang ST, Wu CT, Chang YH, Huang XY, Chang YH, Lin TP, Lin WY, Chuang CK. Effectiveness of a couple-based psychosocial intervention on patients with prostate cancer and their partners: A quasi-experimental study. J Adv Nurs. 2020 Oct;76(10):2572-2585. doi: 10.1111/jan.14471. Epub 2020 Aug 3.
Background: PubMed 33198956Chou MC, Chien CH, Chung HJ, Chuang CK, Wu CT, Pang ST, Liu KL, Chang YH. The Psychometric Properties of Taiwanese Version of the Memorial Anxiety Scale for Prostate Cancer. J Pain Symptom Manage. 2021 Apr;61(4):824-830. doi: 10.1016/j.jpainsymman.2020.10.013. Epub 2020 Oct 24.
Background: PubMed 20119934Cockle-Hearne J, Faithfull S. Self-management for men surviving prostate cancer: a review of behavioural and psychosocial interventions to understand what strategies can work, for whom and in what circumstances. Psychooncology. 2010 Sep;19(9):909-22. doi: 10.1002/pon.1657.
Background: PubMed 12964174Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
Background: PubMed 32663140Crafoord MT, Fjell M, Sundberg K, Nilsson M, Langius-Eklof A. Engagement in an Interactive App for Symptom Self-Management during Treatment in Patients With Breast or Prostate Cancer: Mixed Methods Study. J Med Internet Res. 2020 Aug 10;22(8):e17058. doi: 10.2196/17058.
Individual participant dataSharing planned: No

Related trials for Prostatic Neoplasms

RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma

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. This study is not recruiting at the moment.

Ching-Hui Chien, PhD 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?

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 6 inclusion and 4 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: finished, as of the sponsor's last update on 3 Jan 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cancer related self-efficacy (time frame: Pre-test). The study lists 3 primary outcomes in all. 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 NCT05335967, which also lists 26 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 3 Jan 2025.