NCT06099899

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 20, 2023

Last Update Submit

October 24, 2023

Conditions

Keywords

hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • the hindering factors in physical activities interview

    Colaizzi analysis method

    2 month

Study Arms (2)

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.

Other: interview

parent

The primary caregivers during the home care period for these children.

Other: interview

Interventions

conduct in-depth interviews

childparent

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children during the post-hematopoietic stem cell transplantation period at home

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • QIAN HAO, nurse

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 25, 2023

Study Start

October 30, 2023

Primary Completion

October 30, 2024

Study Completion

December 31, 2024

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share