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

Not Applicable

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Other: Multimedia-Based Hormone Therapy Information Program

• Registration Number: NCT04693910
• Lead Sponsor: National Taipei University of Nursing and Health Sciences

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.

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 Timeline

• Study Start: 2019-05-13
• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimedia information group	Multimedia-Based Hormone Therapy Information Program	The experimental group received a weekly multimedia hormone therapy information program for 6 weeks.

Primary Outcome Measures

Name	Time	Method
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	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	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

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital at Linkou; 🇨🇳 Taoyuan, Taiwan