Quality of Life in Pediatric Patients With Acute Lymphoblastic Leukemia Receiving Maintenance Chemotherapy

NCT ID: NCT03132948

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to evaluate the impact of exercise on physical activity levels and quality of life in children with acute lymphoblastic leukemia (ALL) receiving maintenance chemotherapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Health-related quality of life is an important outcome of cancer treatment which encompasses physical, psychological, social, and functional well-being. In addition, quality of life includes one's overall ability to become a productive member of society and achieve personal fulfillment. Treatment of pediatric cancer is a highly stressful experience which can be challenging and disruptive to the lives of children and their families. Pediatric oncology patients receiving chemotherapy often experience a decline in quality of life due to decreased activity, fatigue, and psychological distress such as depression or anxiety when compared to healthy individuals. Preliminary data suggests that there is an association between physical activity and quality of life. Exercise has been show to improve mood, increase energy levels, and reduce stress. Although more research and clinical resources have been given to the effects of exercise on quality of life among adult cancer patients, there is a lack of research in these areas among children with cancer. The investigators know little about whether children with cancer would benefit from exercise.

The investigators have added a blood sample for biomarkers. Research in adult cancer patients have shown an association between different biomarkers and sleep quality which suggests that regulation of certain biomarkers may be affected through exercise in adults. Measures of biomarkers may provide insight into potential mediators between PA, sleep quality, or fatigue levels.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Physical Activity

Single arm study where patients choose from physical activities after baseline assessment by PT. Activities include the following: Nintendo WII fit console, Xbox Kinect fit console and other sport activities.

Group Type EXPERIMENTAL

Physical Activity

Intervention Type BEHAVIORAL

Nintendo WII fit console, Xbox console, sport activities (soccer, basketball, yoga, walking and other physical games)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical Activity

Nintendo WII fit console, Xbox console, sport activities (soccer, basketball, yoga, walking and other physical games)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pediatric oncology patients with ALL in the maintenance phase of chemotherapy during the time of study
* Ages 8-18 years of either gender (age limits due to reliability and validity of outcome assessment surveys)
* Have no documented or observable psychiatric or neurological disorders that would interfere with study participation
* Capable of speaking and reading English
* Having no contraindications to participate in moderate physical exercise as determined by the research staff and the patient's pediatric oncologist
* Currently living with their parents/legal guardians
* Consent obtained from legal guardians and assent obtained from patients to participate in the study

Exclusion Criteria

* Not a pediatric oncology patient with ALL in maintenance
* Not receiving chemotherapy during the time of study
* Age less than 8 years or greater than 18 years
* Not English-speaking Since not all outcome measures have been validated in Spanish and other languages, only English-speaking patients will be included.
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Connecticut Children's Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andrea Orsey

Hematologist/Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrea Orsey, MD

Role: PRINCIPAL_INVESTIGATOR

Connecticut Children's Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Andrea Orsey, MD

Role: CONTACT

860-545-9630

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Andrea Orsey, MD

Role: primary

860-545-9630

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10-086

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fit to Fight Childhood Cancer
NCT05867186 RECRUITING