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

Sponsor

National Taipei University of Nursing and Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT04693910

Collaborator

Ministry of Science and Technology, Taiwan (Other), Chang Gung Memorial Hospital (Other)

Enrollment

Location

Arms

20.7

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Other: Multimedia-Based Hormone Therapy Information Program	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

May 13, 2019

Actual Primary Completion Date :

Jan 31, 2021

Actual Study Completion Date :

Jan 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multimedia information group The experimental group received a weekly multimedia hormone therapy information program for 6 weeks.	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.
No Intervention: Routine care group The control group will receive routine care.

Arm

Intervention/Treatment

Experimental: Multimedia information group

The experimental group received a weekly multimedia hormone therapy information program for 6 weeks.

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.

No Intervention: Routine care group

The control group will receive routine care.

Outcome Measures

Primary Outcome Measures

Functional Assessment of Cancer Therapy-Prostate (FACT-P) [pretest]
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
Functional Assessment of Cancer Therapy-Prostate (FACT-P) [8 weeks after the pretest]
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
Functional Assessment of Cancer Therapy-Prostate (FACT-P) [12 weeks after the pretest]
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
The Positive Thinking Scale [pretest]
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
The Positive Thinking Scale [8 weeks after the pretest]
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
The Positive Thinking Scale [12 weeks after the pretest]
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
The Hormonal Dimension of The Expanded Prostate Cancer Index Composite [pretest]
11 items were used, the score of each item ranges from 0 to 100 points. Higher scores indicate fewer hormonal symptoms.
The Hormonal Dimension of The Expanded Prostate Cancer Index Composite [8 weeks after the pretest]
11 items were used, the score of each item ranges from 0 to 100 points. Higher scores indicate fewer hormonal symptoms.
The Hormonal Dimension of The Expanded Prostate Cancer Index Composite [12 weeks after the pretest]
11 items were used, the score of each item ranges from 0 to 100 points. Higher scores indicate fewer hormonal symptoms.

Secondary Outcome Measures

The General Self-Efficacy Scale [pretest]
The total scale contains 10 items and a 4-point (1-4) scoring method was adopted. Higher scores indicate higher self-efficacy
The General Self-Efficacy Scale [8 weeks after the pretest]
The total scale contains 10 items and a 4-point (1-4) scoring method was adopted. Higher scores indicate higher self-efficacy
The General Self-Efficacy Scale [12 weeks after the pretest]
The total scale contains 10 items and a 4-point (1-4) scoring method was adopted. Higher scores indicate higher self-efficacy
The Social Support Scale [pretest]
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.
The Social Support Scale [8 weeks after the pretest]
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.
The Social Support Scale [12 weeks after the pretest]
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.

Other Outcome Measures

Basic and disease information list 1 [pretest]
Age
Basic and disease information list 2 [pretest]
Education level
Basic and disease information list 3 [pretest]
Marital status
Basic and disease information list 4 [pretest]
Religion
Basic and disease information list 5 [pretest]
Occupation
Basic and disease information list 6 [pretest]
Annual family income (NTD)
Basic and disease information list 7 [pretest]
Number of children
Basic and disease information list 8 [pretest]
Join a support group
Basic and disease information list 9 [pretest]
Time since diagnosis (months)
Basic and disease information list 10 [pretest]
Tumor-node-metastasis Cancer stage
Basic and disease information list 11 [pretest]
Gleason score
Basic and disease information list 12 [pretest]
Treatment
Basic and disease information list 13 [pretest]
History of chronic disease
Basic and disease information list 14 [pretest]
Living status
Basic and disease information list 15 [pretest]
Height in centimetre
Basic and disease information list 16 [pretest]
Body Mass Index in kg/m2 will be computed from height and body weight
Basic and disease information list 17 [pretest]
Body weight in kilograms
Basic and disease information list 18 [pretest]
Waist circumference in centimetre
Basic and disease information list 19 [pretest]
Serum Prostatic Specific Antigen level
Basic and disease information list 20 [8 weeks after the pretest]
Serum Prostatic Specific Antigen level
Basic and disease information list 21 [12 weeks after the pretest]
Serum Prostatic Specific Antigen level
Basic and disease information list 22 [pretest]
Perceived health status. A 11-point (0-100) scoring method was used. Higher scores indicate better health condition.
Basic and disease information list 23 [8 weeks after the pretest]
Perceived health status. A 11-point (0-100) scoring method was used. Higher scores indicate better health condition.
Basic and disease information list 24 [12 weeks after the pretest]
Perceived health status. A 11-point (0-100) scoring method was used. Higher scores indicate better health condition.
List of satisfaction with Program [8 weeks after the pretest]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with prostate cancer who were receiving hormonal therapy
patients were at least 20 years old
patients were ability to communicate in Chinese or Taiwanese
the married partner agrees to study together, or the single patient has a cohabitation partner who agrees to study together.
patients or family have a smart phone or tablet and can connect to the Internet.

Exclusion Criteria:

having a history of other cancers
unknown diagnosis of prostate cancer or unknown disease status
patients who received chemotherapy, radiotherapy, radical prostatectomy or other treatments for prostate cancer in the past
having history of mental disorder, e.g., phobia, obsessive-compulsive disorder, generalized anxiety, , major depression, mania, manic-depressive psychosis, or dementia
the score of Eastern Cooperative Oncology Group performance is ≧ 2