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NCT Number: NCT04693910

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

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital at Linkou

Taoyuan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimedia-Based Hormone Therapy Information Program

Other

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 outcomes

  1. Functional Assessment of Cancer Therapy-Prostate (FACT-P)

    Time frame: 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

  2. Functional Assessment of Cancer Therapy-Prostate (FACT-P)

    Time frame: 8 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

  3. Functional Assessment of Cancer Therapy-Prostate (FACT-P)

    Time frame: 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

  4. The Positive Thinking Scale

    Time frame: 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

  5. The Positive Thinking Scale

    Time frame: 8 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

  6. The Positive Thinking Scale

    Time frame: 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

  7. The Hormonal Dimension of The Expanded Prostate Cancer Index Composite

    Time frame: pretest

    11 items were used, the score of each item ranges from 0 to 100 points. Higher scores indicate fewer hormonal symptoms.

  8. The Hormonal Dimension of The Expanded Prostate Cancer Index Composite

    Time frame: 8 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.

  9. The Hormonal Dimension of The Expanded Prostate Cancer Index Composite

    Time frame: 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 outcomes

  1. The General Self-Efficacy Scale

    Time frame: pretest

    The total scale contains 10 items and a 4-point (1-4) scoring method was adopted. Higher scores indicate higher self-efficacy

  2. The General Self-Efficacy Scale

    Time frame: 8 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

  3. The General Self-Efficacy Scale

    Time frame: 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

  4. The Social Support Scale

    Time frame: 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.

  5. The Social Support Scale

    Time frame: 8 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.

  6. The Social Support Scale

    Time frame: 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.

Other outcomes

  1. Basic and disease information list 1

    Time frame: pretest

    Age

  2. Basic and disease information list 2

    Time frame: pretest

    Education level

  3. Basic and disease information list 3

    Time frame: pretest

    Marital status

  4. Basic and disease information list 4

    Time frame: pretest

    Religion

  5. Basic and disease information list 5

    Time frame: pretest

    Occupation

  6. Basic and disease information list 6

    Time frame: pretest

    Annual family income (NTD)

  7. Basic and disease information list 7

    Time frame: pretest

    Number of children

  8. Basic and disease information list 8

    Time frame: pretest

    Join a support group

  9. Basic and disease information list 9

    Time frame: pretest

    Time since diagnosis (months)

  10. Basic and disease information list 10

    Time frame: pretest

    Tumor-node-metastasis Cancer stage

  11. Basic and disease information list 11

    Time frame: pretest

    Gleason score

  12. Basic and disease information list 12

    Time frame: pretest

    Treatment

  13. Basic and disease information list 13

    Time frame: pretest

    History of chronic disease

  14. Basic and disease information list 14

    Time frame: pretest

    Living status

  15. Basic and disease information list 15

    Time frame: pretest

    Height in centimetre

  16. Basic and disease information list 16

    Time frame: pretest

    Body Mass Index in kg/m2 will be computed from height and body weight

  17. Basic and disease information list 17

    Time frame: pretest

    Body weight in kilograms

  18. Basic and disease information list 18

    Time frame: pretest

    Waist circumference in centimetre

  19. Basic and disease information list 19

    Time frame: pretest

    Serum Prostatic Specific Antigen level

  20. Basic and disease information list 20

    Time frame: 8 weeks after the pretest

    Serum Prostatic Specific Antigen level

  21. Basic and disease information list 21

    Time frame: 12 weeks after the pretest

    Serum Prostatic Specific Antigen level

  22. Basic and disease information list 22

    Time frame: pretest

    Perceived health status. A 11-point (0-100) scoring method was used. Higher scores indicate better health condition.

  23. Basic and disease information list 23

    Time frame: 8 weeks after the pretest

    Perceived health status. A 11-point (0-100) scoring method was used. Higher scores indicate better health condition.

  24. Basic and disease information list 24

    Time frame: 12 weeks after the pretest

    Perceived health status. A 11-point (0-100) scoring method was used. Higher scores indicate better health condition.

  25. List of satisfaction with Program

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Collaborators

  • Chang Gung Memorial Hospital
  • Ministry of Science and Technology, Taiwan

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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