Clinical trial NCT04693910: Multimedia-based Hormonal Therapy Information Program for Patients With Prostate Cancer
Official title: Development and Evaluation of the Effectiveness of a Multimedia-based Hormonal Therapy Information Program for Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: prostate cancer
hormonal therapy
multimedia
self-efficacy
positive thinking
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
name: Chang Gung Memorial Hospital
First posted: 2021-01-05
Enrollment: 80
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy-Prostate (FACT-P)
timeFrame: pretest
measure: Functional Assessment of Cancer Therapy-Prostate (FACT-P)
timeFrame: 8 weeks after the pretest
measure: Functional Assessment of Cancer Therapy-Prostate (FACT-P)
timeFrame: 12 weeks after the pretest
measure: The Positive Thinking Scale
timeFrame: pretest
measure: The Positive Thinking Scale
timeFrame: 8 weeks after the pretest
measure: The Positive Thinking Scale
timeFrame: 12 weeks after the pretest
measure: The Hormonal Dimension of The Expanded Prostate Cancer Index Composite
timeFrame: pretest
measure: The Hormonal Dimension of The Expanded Prostate Cancer Index Composite
timeFrame: 8 weeks after the pretest
measure: The Hormonal Dimension of The Expanded Prostate Cancer Index Composite
timeFrame: 12 weeks after the pretest
Secondary outcomes:
measure: The General Self-Efficacy Scale
timeFrame: pretest
measure: The General Self-Efficacy Scale
timeFrame: 8 weeks after the pretest
measure: The General Self-Efficacy Scale
timeFrame: 12 weeks after the pretest
measure: The Social Support Scale
timeFrame: pretest
measure: The Social Support Scale
timeFrame: 8 weeks after the pretest
measure: The Social Support Scale
timeFrame: 12 weeks after the pretest
Other outcomes:
measure: Basic and disease information list 1
timeFrame: pretest
measure: Basic and disease information list 2
timeFrame: pretest
measure: Basic and disease information list 3
timeFrame: pretest
measure: Basic and disease information list 4
timeFrame: pretest
measure: Basic and disease information list 5
timeFrame: pretest
measure: Basic and disease information list 6
timeFrame: pretest
measure: Basic and disease information list 7
timeFrame: pretest
measure: Basic and disease information list 8
timeFrame: pretest
measure: Basic and disease information list 9
timeFrame: pretest
measure: Basic and disease information list 10
timeFrame: pretest
measure: Basic and disease information list 11
timeFrame: pretest
measure: Basic and disease information list 12
timeFrame: pretest
measure: Basic and disease information list 13
timeFrame: pretest
measure: Basic and disease information list 14
timeFrame: pretest
measure: Basic and disease information list 15
timeFrame: pretest
measure: Basic and disease information list 16
timeFrame: pretest
measure: Basic and disease information list 17
timeFrame: pretest
measure: Basic and disease information list 18
timeFrame: pretest
measure: Basic and disease information list 19
timeFrame: pretest
measure: Basic and disease information list 20
timeFrame: 8 weeks after the pretest
measure: Basic and disease information list 21
timeFrame: 12 weeks after the pretest
measure: Basic and disease information list 22
timeFrame: pretest
measure: Basic and disease information list 23
timeFrame: 8 weeks after the pretest
measure: Basic and disease information list 24
timeFrame: 12 weeks after the pretest
measure: List of satisfaction with Program
timeFrame: 8 weeks after the pretest
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital at Linkou
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences, Taipei city, Taiwan
name: Ching-Hui Chien, PhD
role: PRINCIPAL_INVESTIGATOR
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