Chemotherapy Side EffectsNCT06791603
The Impact of Social Media-delivered Chemotherapy Side Effects Education for Breast Cancer Patients Receiving Chemotherapy
A study testing Standardized chemotherapy education + video in people with Chemotherapy Side Effects and Social Media, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Side Effects, Social Media, Education of Patients
- What is being tested?
- Standardized chemotherapy education + video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jan 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients aged 18 or older undergoing their first chemotherapy.
- Possess a smartphone and are able to watch videos on it.
Who cannot join
- Unable to read or complete questionnaires in Chinese.
- Cognitive impairments.
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Shuang Ho Hospital
New Taipei City
Pohung Lin, 02-2249-0088 #1168, 19365@s.tmu.edu.tw
About this study
Official title: 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).
Read more
Participants will:
- Received standardized chemotherapy education + video or chemotherapy handouts at the first and second chemotherapy section.
- Fill out a questionnaire for outcomes assessment.
Read the 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.
- Being tested
- Standardized chemotherapy education + video
- Keywords
- pharmacist, chemotherapy education, social media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized chemotherapy education + videoOther
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
| Study group | Role | What they receive |
|---|---|---|
| Standardized chemotherapy education + video | Experimental | Standardized chemotherapy education+ video Receives: Other: Standardized chemotherapy education + video |
| Chemotherapy handouts | No intervention | Chemotherapy handouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
A questionnaire with 5 questions of side effects management
Each question is a multiple choice with 4 options and 1 correct answer
Measured: 1. First time receiving chemotherapy 2. Second time receiving chemotherapy (3 to 4 weeks depend on schedule)
Secondary outcomes (1)
FACT-B, The Functional Assessment of Cancer Therapy - Breast
Measured: 1. First time receiving chemotherapy 2. Second time receiving chemotherapy (3 to 4 weeks depend on schedule)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start6 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Side EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pohung Lin, Taipei Medical University Shuang Ho Hospital
- Investigators
- Pohung Lin, PharmD, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791603
- Sponsor's protocol ID
- TMU-JIRB N202410024
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Social Media-delivered Chemotherapy-related Side Effects Education for Breast Cancer Patients Receiving First Time Chemotherapy
- ClinicalTrials.gov ID
- NCT06791603
- Acronym / sponsor ID
- TMU-JIRB N202410024
- Keywords
- pharmacist, chemotherapy education, social media
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized chemotherapy education + video | Experimental | Other: Standardized chemotherapy education + videoStandardized chemotherapy education+ video |
| Chemotherapy handouts | No intervention | –Chemotherapy handouts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Breast cancer patients aged 18 or older undergoing their first chemotherapy.
- Possess a smartphone and are able to watch videos on it.
Key exclusion criteria (3 listed)
- Unable to read or complete questionnaires in Chinese.
- Cognitive impairments.
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized chemotherapy education + videoVideos 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 | Other | Standardized chemotherapy education + video |
Primary outcome
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 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pohung Lin, PharmD principal investigator
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized chemotherapy education + video in people with Chemotherapy Side Effects and Social Media, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pohung Lin, PharmD (886-933-826-267, 19365@s.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.