- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06791603
The Impact of Social Media-delivered Chemotherapy Side Effects Education for Breast Cancer Patients Receiving Chemotherapy
The Impact of Social Media-delivered Chemotherapy-related Side Effects Education for Breast Cancer Patients Receiving First Time Chemotherapy
The goal of this clinical trial is to learn if a standardized pharmacists-provided education module by social media can improve patients' knowledge of chemotherapy-related side effects. The main questions it aims to answer is:
• Do patients who received a standardized pharmacists-provided education module by social media improve their knowledge of chemotherapy-related side effects? Researchers will compare standardized chemotherapy education +video (experimental group) versus chemotherapy handouts (control group).
Participants will:
- Received standardized chemotherapy education + video or chemotherapy handouts at the first and second chemotherapy section.
- Fill out a questionnaire for outcomes assessment.
Study Overview
Status
Intervention / Treatment
Detailed Description
The pharmacist-provided video education model for patients undergoing first time chemotherapy was developed. The content of the education video included the mechanism of side effects, its recognition, preventive measures, non-medical management, and further instructions when to visit hospital were included.
Patients were randomly assigned into two groups with different education strategies:
Standardized chemotherapy education +video (experimental group) versus chemotherapy handouts (control group). Every patient was asked to fill out a questionnaire prior to the implementation of the education model in both groups. The pre-test questionnaires consisted of baseline knowledge and personal information. Patients in the experimental group would receive standardized chemotherapy education by pharmacists, including chemotherapy regimen, the purpose of chemotherapy, the number of cycles, duration of chemotherapy and the common side effects of chemotherapy on the first day of chemotherapy cycle. Videos will be provided with patients and they will watch videos during the visit. The information regarding the prevention and management of side effects and further instructions when to visit hospital. Patients will have access to videos and watch videos after leaving the hospital for the entire treatment course. The education time will be last around 15 to 20 minutes. In terms of control group, pharmacists will briefly explain and provide chemotherapy handouts, including chemotherapy regimen, the purpose of chemotherapy, the number of cycles, duration of chemotherapy and the common side effects of chemotherapy. The duration of visit will be around 5 to 10 minutes. After the education section, patients will be asked to do a post-test questionnaire of their knowledge and quality of life.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pohung Lin, PharmD
- Phone Number: 886-933-826-267
- Email: 19365@s.tmu.edu.tw
Study Locations
-
-
-
New Taipei City, Taiwan
- Recruiting
- Shuang Ho Hospital
-
Contact:
- Pohung Lin
- Phone Number: 02-2249-0088 #1168
- Email: 19365@s.tmu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Breast cancer patients aged 18 or older undergoing their first chemotherapy.
- Possess a smartphone and are able to watch videos on it.
Exclusion Criteria:
- Unable to read or complete questionnaires in Chinese.
- Cognitive impairments.
- Pregnant women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Standardized chemotherapy education + video
Standardized chemotherapy education+ video
|
Videos will be provided with patients and they will watch videos during the visit.
The information regarding the prevention and management of side effects and further instructions when to visit hospital.
Patients will have access to videos and watch videos after leaving the hospital for the entire treatment course
|
|
No Intervention: Chemotherapy handouts
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A questionnaire with 5 questions of side effects management
Time Frame: 1. First time receiving chemotherapy 2. Second time receiving chemotherapy (3 to 4 weeks depend on schedule)
|
Each question is a multiple choice with 4 options and 1 correct answer
|
1. First time receiving chemotherapy 2. Second time receiving chemotherapy (3 to 4 weeks depend on schedule)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
FACT-B, The Functional Assessment of Cancer Therapy - Breast
Time Frame: 1. First time receiving chemotherapy 2. Second time receiving chemotherapy (3 to 4 weeks depend on schedule)
|
1. First time receiving chemotherapy 2. Second time receiving chemotherapy (3 to 4 weeks depend on schedule)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pohung Lin, PharmD, Taipei Medical University Shuang Ho Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TMU-JIRB N202410024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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