- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06099899
Qualitative Study on Factors Impeding Physical Activity During the Post-discharge Period After Hematopoietic Stem Cell Transplantation in Children
October 24, 2023 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The purpose is to gain a deep understanding of the hindering factors in physical activities during the home period after pediatric hematopoietic stem cell transplantation, in order to provide references for developing targeted intervention measures.
Study Overview
Detailed Description
From October 2023 to September 2024, a purposive sampling method will be used to select 10 post-pediatric hematopoietic stem cell transplant patients and 10 family members receiving treatment at Sun Yat-sen Memorial Hospital, Zhongshan University, as the subjects for the study.
The phenomenological approach in qualitative research will be employed to conduct in-depth interviews with them, and data analysis will be performed using the Colaizzi analysis method.
Study Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: QIAN HAO
- Phone Number: 13560462080
- Email: qianh5@mail.sysu.edu.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Children during the post-hematopoietic stem cell transplantation period at home
Description
Inclusion Criteria:
- The child's age ranges from 8 to 18 years old.
- They have undergone hematopoietic stem cell transplantation for at least one month.
- They do not have any mental disorders or consciousness impairments.
- The child is capable of independent walking.
- The interviewees are able to express their thoughts clearly.
- Both the child and their family members are informed about and have given consent to participate in this study.
Exclusion Criteria:
- Relapse or the presence of other tumors
- Physical activity prohibitions, such as movement disorders, platelet count <20×10⁹, -acute bleeding, hemoglobin level <80g/L
- Fever with a temperature of 38.8℃ or higher due to infection
- Pain score of 4 or higher
- Other severe complications, such as heart failure or severe malnutrition.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
child
The child's age ranges from 8 to 18 years old.
They have undergone hematopoietic stem cell transplantation for at least one month.
They do not have any mental disorders or consciousness impairments.
The child is capable of independent walking.
The interviewees are able to express their thoughts clearly.
|
conduct in-depth interviews
|
|
parent
The primary caregivers during the home care period for these children.
|
conduct in-depth interviews
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the hindering factors in physical activities interview
Time Frame: 2 month
|
Colaizzi analysis method
|
2 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: QIAN HAO, nurse, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 30, 2023
Primary Completion (Estimated)
October 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
October 20, 2023
First Submitted That Met QC Criteria
October 24, 2023
First Posted (Actual)
October 25, 2023
Study Record Updates
Last Update Posted (Actual)
October 25, 2023
Last Update Submitted That Met QC Criteria
October 24, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- SYSKY-2023-972-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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