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

NCT03132948 | Suspended

• 1 other identifier: 10-086
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Quality of Life

Keywords

ALL Cancer Patients; Quality of Life; Fitness

Outcome Measures

Primary Outcomes (1)

• Quality of Life Outcomes

  PedsQL

  1 year

Secondary Outcomes (3)

• Physical Activity

  1 year

• Sleep

  1 year

• Fatigue

  1 year

Study Arms (1)

Physical Activity

EXPERIMENTAL

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.

Behavioral: Physical Activity

Interventions

Physical Activity BEHAVIORAL

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

Physical Activity

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Andrea Orsey, MD

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hematologist/Oncologist

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: April 28, 2017
• Study Start: November 9, 2009
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: following completion of study for 5 years
• Access Criteria: Researchers may contact PI

Locations

US (1)