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

NCT04693910 | Completed

• 1 other identifier: 201602024B0C501
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

prostate cancer; hormonal therapy; multimedia; self-efficacy; positive thinking

Outcome Measures

Primary Outcomes (9)

• 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

  pretest

• 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

  8 weeks after the pretest

• 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

  12 weeks after the pretest

• 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

  pretest

• 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

  8 weeks after the pretest

• 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

  12 weeks after the pretest

• 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.

  pretest

• 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.

  8 weeks after the pretest

• 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.

  12 weeks after the pretest

Secondary Outcomes (6)

• The General Self-Efficacy Scale

  pretest

• The General Self-Efficacy Scale

  8 weeks after the pretest

• The General Self-Efficacy Scale

  12 weeks after the pretest

• The Social Support Scale

  pretest

• The Social Support Scale

  8 weeks after the pretest

Other Outcomes (25)

• Basic and disease information list 1

  pretest

• Basic and disease information list 2

  pretest

• Basic and disease information list 3

  pretest

Study Arms (2)

Multimedia information group

EXPERIMENTAL

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

Other: Multimedia-Based Hormone Therapy Information Program

Routine care group

NO INTERVENTION

The control group will receive routine care.

Interventions

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.

Multimedia information group

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Ministry of Science and Technology, Taiwan: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Chang Gung Memorial Hospital at Linkou

Taoyuan District, Taiwan

Location

Related Publications (18)

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  PMID: 38155164 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ching-Hui Chien, PhD

  National Taipei University of Nursing and Health Sciences, Taipei city, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN PhD Associate Professor

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 5, 2021
• Study Start: May 13, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)