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Trial Title:
Childhood Cancer Survivors' Affective Response to Exercise
NCT ID:
NCT05763290
Condition:
ALL, Childhood
Acute Lymphoblastic Leukemia
Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Affective Response to Exercise
Description:
Participants will perform a total of three trials of a cognitive task before and after
their scheduled SJLIFE cardiovascular stress testing. Participants will then be asked to
participate in a qualitative interview about the cognitive task tool and body sensations
and emotions experienced during exercise.
Summary:
The primary objective of this study is to assess the feasibility of administering the
Personalized Single-Category Implicit Association Test (PSC-IAT) to young adult survivors
of childhood cancer.
Participants will perform a total of three trials of a cognitive task before and after
their scheduled SJLIFE cardiovascular stress testing. Participants will then be asked to
participate in a qualitative interview about the cognitive task tool and body sensations
and emotions experienced during exercise.
Detailed description:
Researchers at St. Jude Children's Research Hospital want to learn about the measurement
of implicit association bias towards or against exercise in childhood cancer survivors.
Additionally, researchers want to learn more about the physical and emotional experience
of exercise from our survivors.
The plan for this study is to administer single category implicit association tests
(PSC-IAT's) to participants during on campus SJLIFE testing and use this data to
determine the feasibility of this tool's use in survivors of childhood cancer without
cognitive impairment. This study will also administer the Behavioral Regulations in
Exercise Questionnaire (BREQ-2)37 to participants as a construct validity check to the
PSC-IAT.
The procedures include PSC-IAT and BREQ-2 tests (before and after strenuous exercise as
part of the SJLIFE protocol) and a qualitative interview. These will be in addition to
standard components of the SJLIFE on-campus visit.
Criteria for eligibility:
Study pop:
The study population will include survivors from the SJLIFE cohort from the ALL
diagnostic group (treated without cranial radiation therapy (CRT). This group was chosen
because of the prevalence of ALL in childhood cancer diagnoses, and to attempt to prevent
potential difficulties with the cognitive task due to cognitive impairment from CRT.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Participants enrolled in St. Jude Lifetime Cohort (SJLIFE) aged 18-39 years at
completion of on campus visit
- Primary diagnosis of acute lymphoblastic leukemia (ALL)
- No cranial radiation therapy (CRT) as part of treatment for ALL
- Identify as physically inactive (do not meet Centers for Disease Control and
Prevention (CDC) guidelines of 150 minutes of moderate physical activity per week or
75 minutes of vigorous physical activity per week)
- Women who are not currently pregnant
Exclusion Criteria:
- Individuals who cannot speak, read, and/or understand English.
- Individuals with an estimated IQ of <70 and/or per PI discretion
- Individuals with any contraindication to stress testing (i.e. cardiovascular
complications)
- Women who are currently pregnant
Gender:
All
Minimum age:
18 Years
Maximum age:
39 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Megan Ware, MS, PhD
Phone:
866-278-5833
Email:
referralinfo@stjude.org
Start date:
March 22, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
St. Jude Children's Research Hospital
Agency class:
Other
Source:
St. Jude Children's Research Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05763290
