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

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Multimedia-Based Hormone Therapy Information Program
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostatic Neoplasms focused on measuring prostate cancer, hormonal therapy, multimedia, self-efficacy, positive thinking

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital at Linkou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multimedia information group

Routine care group

Arm Description

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

The control group will receive routine care.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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.
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.
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.

Secondary Outcome Measures

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
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
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
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.
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.
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.

Full Information

First Posted
December 23, 2020
Last Updated
March 3, 2021
Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Ministry of Science and Technology, Taiwan, Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04693910
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Ministry of Science and Technology, Taiwan, Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
prostate cancer, hormonal therapy, multimedia, self-efficacy, positive thinking

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multimedia information group
Arm Type
Experimental
Arm Description
The experimental group received a weekly multimedia hormone therapy information program for 6 weeks.
Arm Title
Routine care group
Arm Type
No Intervention
Arm Description
The control group will receive routine care.
Intervention Type
Other
Intervention Name(s)
Multimedia-Based Hormone Therapy Information Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Description
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
Time Frame
pretest
Title
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Description
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
Time Frame
8 weeks after the pretest
Title
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Description
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
Time Frame
12 weeks after the pretest
Title
The Positive Thinking Scale
Description
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
Time Frame
pretest
Title
The Positive Thinking Scale
Description
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
Time Frame
8 weeks after the pretest
Title
The Positive Thinking Scale
Description
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
Time Frame
12 weeks after the pretest
Title
The Hormonal Dimension of The Expanded Prostate Cancer Index Composite
Description
11 items were used, the score of each item ranges from 0 to 100 points. Higher scores indicate fewer hormonal symptoms.
Time Frame
pretest
Title
The Hormonal Dimension of The Expanded Prostate Cancer Index Composite
Description
11 items were used, the score of each item ranges from 0 to 100 points. Higher scores indicate fewer hormonal symptoms.
Time Frame
8 weeks after the pretest
Title
The Hormonal Dimension of The Expanded Prostate Cancer Index Composite
Description
11 items were used, the score of each item ranges from 0 to 100 points. Higher scores indicate fewer hormonal symptoms.
Time Frame
12 weeks after the pretest
Secondary Outcome Measure Information:
Title
The General Self-Efficacy Scale
Description
The total scale contains 10 items and a 4-point (1-4) scoring method was adopted. Higher scores indicate higher self-efficacy
Time Frame
pretest
Title
The General Self-Efficacy Scale
Description
The total scale contains 10 items and a 4-point (1-4) scoring method was adopted. Higher scores indicate higher self-efficacy
Time Frame
8 weeks after the pretest
Title
The General Self-Efficacy Scale
Description
The total scale contains 10 items and a 4-point (1-4) scoring method was adopted. Higher scores indicate higher self-efficacy
Time Frame
12 weeks after the pretest
Title
The Social Support Scale
Description
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.
Time Frame
pretest
Title
The Social Support Scale
Description
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.
Time Frame
8 weeks after the pretest
Title
The Social Support Scale
Description
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.
Time Frame
12 weeks after the pretest
Other Pre-specified Outcome Measures:
Title
Basic and disease information list 1
Description
Age
Time Frame
pretest
Title
Basic and disease information list 2
Description
Education level
Time Frame
pretest
Title
Basic and disease information list 3
Description
Marital status
Time Frame
pretest
Title
Basic and disease information list 4
Description
Religion
Time Frame
pretest
Title
Basic and disease information list 5
Description
Occupation
Time Frame
pretest
Title
Basic and disease information list 6
Description
Annual family income (NTD)
Time Frame
pretest
Title
Basic and disease information list 7
Description
Number of children
Time Frame
pretest
Title
Basic and disease information list 8
Description
Join a support group
Time Frame
pretest
Title
Basic and disease information list 9
Description
Time since diagnosis (months)
Time Frame
pretest
Title
Basic and disease information list 10
Description
Tumor-node-metastasis Cancer stage
Time Frame
pretest
Title
Basic and disease information list 11
Description
Gleason score
Time Frame
pretest
Title
Basic and disease information list 12
Description
Treatment
Time Frame
pretest
Title
Basic and disease information list 13
Description
History of chronic disease
Time Frame
pretest
Title
Basic and disease information list 14
Description
Living status
Time Frame
pretest
Title
Basic and disease information list 15
Description
Height in centimetre
Time Frame
pretest
Title
Basic and disease information list 16
Description
Body Mass Index in kg/m2 will be computed from height and body weight
Time Frame
pretest
Title
Basic and disease information list 17
Description
Body weight in kilograms
Time Frame
pretest
Title
Basic and disease information list 18
Description
Waist circumference in centimetre
Time Frame
pretest
Title
Basic and disease information list 19
Description
Serum Prostatic Specific Antigen level
Time Frame
pretest
Title
Basic and disease information list 20
Description
Serum Prostatic Specific Antigen level
Time Frame
8 weeks after the pretest
Title
Basic and disease information list 21
Description
Serum Prostatic Specific Antigen level
Time Frame
12 weeks after the pretest
Title
Basic and disease information list 22
Description
Perceived health status. A 11-point (0-100) scoring method was used. Higher scores indicate better health condition.
Time Frame
pretest
Title
Basic and disease information list 23
Description
Perceived health status. A 11-point (0-100) scoring method was used. Higher scores indicate better health condition.
Time Frame
8 weeks after the pretest
Title
Basic and disease information list 24
Description
Perceived health status. A 11-point (0-100) scoring method was used. Higher scores indicate better health condition.
Time Frame
12 weeks after the pretest
Title
List of satisfaction with Program
Description
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.
Time Frame
8 weeks after the pretest

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Hui Chien, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences, Taipei city, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital at Linkou
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data of this study will be kept and managed by PI of Ching-Hui Chien.
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Multimedia-based Hormonal Therapy Information Program for Patients With Prostate Cancer

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