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

Connecticut Children's Medical Center

Status: Enrolling

Conditions: Quality of Life

Treatments: Behavioral: Physical Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT03132948

10-086

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Physical Activity

Experimental group

Description:

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.

Treatment:

Behavioral: Physical Activity