Childhood Cancer Survivors' Affective Response to Exercise

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Childhood Cancer Survivors' Affective Response to Exercise

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763290
• Other study ID #: CAREX
• Status: Recruiting
• Start date: March 22, 2023
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: St. Jude Children's Research Hospital
• Contact: Megan Ware, MS, PhD
• Phone: 866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• ALL, Childhood
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• Affective Response to Exercise
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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implicit Association Bias Testing	Participants' implicit associations with exercise will be measured using the Personalized Single-Category Implicit Association test (PSC-IAT).	Before and after Cardiovascular Stress Testing at Baseline
Primary	Behavioral Regulation of Exercise Questionnaire (BREQ-2):	The Behavioral Regulation of Exercise Questionnaire (BREQ-2) will be administered once to participants in this study to assess trait-level affective motivation.	Before and after Cardiovascular Stress Testing at Baseline