Prostatic Neoplasms
Conditions
Keywords
prostate cancer, hormonal therapy, multimedia, self-efficacy, positive thinking
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.
Interventions
OTHERMultimedia-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.
Sponsors
Ministry of Science and Technology, Taiwan
Chang Gung Memorial Hospital
National Taipei University of Nursing and Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 1 | pretest | Age |
| Basic and disease information list 8 | pretest | Join a support group |
| 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 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. |
| Basic and disease information list 2 | pretest | Education level |
| 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 |
Countries
Taiwan
Outcome results
None listed