Multimedia-based Hormonal Therapy Information Program for Patients With Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

Development and Evaluation of the Effectiveness of a Multimedia-based Hormonal Therapy Information Program for Patients With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693910
• Other study ID #: 201602024B0C501
• Status: Completed
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: March 2021
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study takes place in the Divisions of Urology. Patients who have only received hormonal therapy will be enrolled. Patients will be randomly sorted into an experimental group and a control group after completing a pretest questionnaire. The experimental group will receive the the multimedia hormone therapy information program once per week for 6 consecutive weeks, while the control group will receive routine care. The follow-up data collections will be completed at 8 and 12 weeks after the pretest. For quantitative measurement, the main variables will be social support, self-efficacy, quality of life, and positive thinking.

Description:

This study takes place in the Divisions of Urology at Chang Gung Memorial Hospitals. Patients who have only received hormonal therapy will be enrolled. With reference to past research findings, self-efficacy theory, and experts' advice, a multimedia hormone therapy information program was developed. The multimedia hormone therapy information program covered 6 topics, namely the recognition of hormone therapy and multimedia information programs, mindfulness, exercise, stress relief, positive thinking, and prevention or reduction of fatigue. A pilot study will be conducted to check the feasibility of intervention study design and the effectiveness of the program will be tested. Patients will be randomly sorted into an experimental group (multimedia information group, n = 36 to 40) and a control group (routine care group, n = 36 to 40) after completing a pretest questionnaire. The experimental group will receive the multimedia information intervention once per week for 6 consecutive weeks, while the control group will receive routine care. The follow-up data collections will be completed at 8 and 12 weeks after the pretest. For quantitative measurement, the main variables will be social support, self-efficacy, quality of life, positive thinking, and satisfaction with program. Generalized Estimating Equations (GEEs) will be used to o analyze data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. patients with prostate cancer who were receiving hormonal therapy

2. patients were at least 20 years old

3. patients were ability to communicate in Chinese or Taiwanese

4. the married partner agrees to study together, or the single patient has a cohabitation partner who agrees to study together.

5. patients or family have a smart phone or tablet and can connect to the Internet.

Exclusion Criteria:

1. having a history of other cancers

2. unknown diagnosis of prostate cancer or unknown disease status

3. patients who received chemotherapy, radiotherapy, radical prostatectomy or other treatments for prostate cancer in the past

4. having history of mental disorder, e.g., phobia, obsessive-compulsive disorder, generalized anxiety, , major depression, mania, manic-depressive psychosis, or dementia

5. the score of Eastern Cooperative Oncology Group performance is ? 2

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Other:
• Multimedia-Based Hormone Therapy Information Program
The multimedia hormone therapy information program lasted 6 weeks and covered 6 topics, namely the recognition of hormone therapy and multimedia information programs, mindfulness, exercise, stress relief, positive thinking, and prevention or reduction of fatigue.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital at Linkou	Taoyuan

Sponsors (3)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences	Chang Gung Memorial Hospital, Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (17)

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Basic and disease information list 1	Age	pretest
Other	Basic and disease information list 2	Education level	pretest
Other	Basic and disease information list 3	Marital status	pretest
Other	Basic and disease information list 4	Religion	pretest
Other	Basic and disease information list 5	Occupation	pretest
Other	Basic and disease information list 6	Annual family income (NTD)	pretest
Other	Basic and disease information list 7	Number of children	pretest
Other	Basic and disease information list 8	Join a support group	pretest
Other	Basic and disease information list 9	Time since diagnosis (months)	pretest
Other	Basic and disease information list 10	Tumor-node-metastasis Cancer stage	pretest
Other	Basic and disease information list 11	Gleason score	pretest
Other	Basic and disease information list 12	Treatment	pretest
Other	Basic and disease information list 13	History of chronic disease	pretest
Other	Basic and disease information list 14	Living status	pretest
Other	Basic and disease information list 15	Height in centimetre	pretest
Other	Basic and disease information list 16	Body Mass Index in kg/m2 will be computed from height and body weight	pretest
Other	Basic and disease information list 17	Body weight in kilograms	pretest
Other	Basic and disease information list 18	Waist circumference in centimetre	pretest
Other	Basic and disease information list 19	Serum Prostatic Specific Antigen level	pretest
Other	Basic and disease information list 20	Serum Prostatic Specific Antigen level	8 weeks after the pretest
Other	Basic and disease information list 21	Serum Prostatic Specific Antigen level	12 weeks after the pretest
Other	Basic and disease information list 22	Perceived health status. A 11-point (0-100) scoring method was used. Higher scores indicate better health condition.	pretest
Other	Basic and disease information list 23	Perceived health status. A 11-point (0-100) scoring method was used. Higher scores indicate better health condition.	8 weeks after the pretest
Other	Basic and disease information list 24	Perceived health status. A 11-point (0-100) scoring method was used. Higher scores indicate better health condition.	12 weeks after the pretest
Other	List of satisfaction with Program	Five items were self-designed to understand the satisfaction of men in the experimental group. A 11-point (0-100) scoring method was used. Higher scores indicate higher satisfaction.	8 weeks after the pretest
Primary	Functional Assessment of Cancer Therapy-Prostate (FACT-P)	A total of 39 items, including five subdimensions, namely, physical well-being, social/family well-being, emotional well-being, functional well-being, and prostate cancer subscales. A 5-point scoring method was adopted. Higher scores indicate higher quality of life	pretest
Primary	Functional Assessment of Cancer Therapy-Prostate (FACT-P)	A total of 39 items, including five subdimensions, namely, physical well-being, social/family well-being, emotional well-being, functional well-being, and prostate cancer subscales. A 5-point scoring method was adopted. Higher scores indicate higher quality of life	8 weeks after the pretest
Primary	Functional Assessment of Cancer Therapy-Prostate (FACT-P)	A total of 39 items, including five subdimensions, namely, physical well-being, social/family well-being, emotional well-being, functional well-being, and prostate cancer subscales. A 5-point scoring method was adopted. Higher scores indicate higher quality of life	12 weeks after the pretest
Primary	The Positive Thinking Scale	A total of 18 items, including two subscales of personal satisfaction and goal pursuit. A five-point (1-5) scoring method was used. Higher scores indicate a higher level of positive thinking	pretest
Primary	The Positive Thinking Scale	A total of 18 items, including two subscales of personal satisfaction and goal pursuit. A five-point (1-5) scoring method was used. Higher scores indicate a higher level of positive thinking	8 weeks after the pretest
Primary	The Positive Thinking Scale	A total of 18 items, including two subscales of personal satisfaction and goal pursuit. A five-point (1-5) scoring method was used. Higher scores indicate a higher level of positive thinking	12 weeks after the pretest
Primary	The Hormonal Dimension of The Expanded Prostate Cancer Index Composite	11 items were used, the score of each item ranges from 0 to 100 points. Higher scores indicate fewer hormonal symptoms.	pretest
Primary	The Hormonal Dimension of The Expanded Prostate Cancer Index Composite	11 items were used, the score of each item ranges from 0 to 100 points. Higher scores indicate fewer hormonal symptoms.	8 weeks after the pretest
Primary	The Hormonal Dimension of The Expanded Prostate Cancer Index Composite	11 items were used, the score of each item ranges from 0 to 100 points. Higher scores indicate fewer hormonal symptoms.	12 weeks after the pretest
Secondary	The General Self-Efficacy Scale	The total scale contains 10 items and a 4-point (1-4) scoring method was adopted. Higher scores indicate higher self-efficacy	pretest
Secondary	The General Self-Efficacy Scale	The total scale contains 10 items and a 4-point (1-4) scoring method was adopted. Higher scores indicate higher self-efficacy	8 weeks after the pretest
Secondary	The General Self-Efficacy Scale	The total scale contains 10 items and a 4-point (1-4) scoring method was adopted. Higher scores indicate higher self-efficacy	12 weeks after the pretest
Secondary	The Social Support Scale	A total of 16 items, including four sub-scales of emotional, informational, appraisal, and instrumental support. A 4-point scoring method (0-3) was used. Higher scores indicate stronger support.	pretest
Secondary	The Social Support Scale	A total of 16 items, including four sub-scales of emotional, informational, appraisal, and instrumental support. A 4-point scoring method (0-3) was used. Higher scores indicate stronger support.	8 weeks after the pretest
Secondary	The Social Support Scale	A total of 16 items, including four sub-scales of emotional, informational, appraisal, and instrumental support. A 4-point scoring method (0-3) was used. Higher scores indicate stronger support.	12 weeks after the pretest