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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Other: Multimedia-Based Hormone Therapy Information Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimedia information group<br>The experimental group received a weekly multimedia hormone therapy information program for 6 weeks. | Other: Multimedia-Based Hormone Therapy Information Program<br>* 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.<br>|
| No Intervention: Routine care group<br>The control group will receive routine care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, hormonal therapy, multimedia, self-efficacy, positive thinking