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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03132948
• Other study ID #: Physical Activity and QOL
• Status: Recruiting
• Phase: N/A
• Start date: October 2010
• Est. completion date: December 2028

Study information

• Verified date: February 2024
• Source: Connecticut Children's Medical Center
• Contact: Andrea Orsey, MD
• Phone: 860-545-9630
• Email: aorsey[@]ccmckids.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Quality of Life

Intervention

Behavioral:
• Physical Activity
Nintendo WII fit console, Xbox console, sport activities (soccer, basketball, yoga, walking and other physical games)

Locations

Country	Name	City	State
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life Outcomes	PedsQL	1 year
Secondary	Physical Activity	Actigraphy	1 year
Secondary	Sleep	Diary	1 year
Secondary	Fatigue	Childhood Fatigue Scale	1 year