Clinical trial NCT03132948: Quality of Life in Pediatric Patients With Acute Lymphoblastic Leukemia Receiving Maintenance Chemotherapy
Official title: Physical Activity and Quality of Life in Pediatric Patients With Acute Lymphoblastic Leukemia Receiving Maintenance Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Quality of Life
Keywords: ALL Cancer Patients
Quality of Life
Fitness
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 25
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life Outcomes
timeFrame: 1 year
Secondary outcomes:
measure: Physical Activity
timeFrame: 1 year
measure: Sleep
timeFrame: 1 year
measure: Fatigue
timeFrame: 1 year
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: Connecticut Children's Medical Center
name: Andrea Orsey, MD
role: PRINCIPAL_INVESTIGATOR
References: