Skip to content

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

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

Status
Suspended
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03132948
Enrollment
25
Registered
2017-04-28
Start date
2009-11-09
Completion date
2031-12-31
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

Keywords

ALL Cancer Patients, Quality of Life, Fitness

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.

Detailed description

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.

Interventions

BEHAVIORALPhysical Activity

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

Sponsors

Connecticut Children's Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life Outcomes1 yearPedsQL

Secondary

MeasureTime frameDescription
Physical Activity1 yearActigraphy
Sleep1 yearDiary
Fatigue1 yearChildhood Fatigue Scale

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAndrea Orsey, MD

Connecticut Children's Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026