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

Primary Purpose

Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
Connecticut Children's Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Quality of Life focused on measuring ALL Cancer Patients, Quality of Life, Fitness

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Connecticut Children's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical Activity

Arm 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.

Outcomes

Primary Outcome Measures

Quality of Life Outcomes
PedsQL

Secondary Outcome Measures

Physical Activity
Actigraphy
Sleep
Diary
Fatigue
Childhood Fatigue Scale

Full Information

First Posted
January 31, 2017
Last Updated
February 7, 2023
Sponsor
Connecticut Children's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03132948
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Connecticut Children's Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life
Keywords
ALL Cancer Patients, Quality of Life, Fitness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
Nintendo WII fit console, Xbox console, sport activities (soccer, basketball, yoga, walking and other physical games)
Primary Outcome Measure Information:
Title
Quality of Life Outcomes
Description
PedsQL
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Physical Activity
Description
Actigraphy
Time Frame
1 year
Title
Sleep
Description
Diary
Time Frame
1 year
Title
Fatigue
Description
Childhood Fatigue Scale
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Orsey, MD
Phone
860-545-9630
Email
aorsey@ccmckids.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Orsey, MD
Organizational Affiliation
Connecticut Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Orsey, MD
Phone
860-545-9630
Email
aorsey@ccmckids.org
First Name & Middle Initial & Last Name & Degree
Eileen Gillan, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
data will be de-identified to protect PHI
IPD Sharing Time Frame
following completion of study for 5 years
IPD Sharing Access Criteria
Researchers may contact PI

Learn more about this trial

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

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