Clinical trial NCT05763290: Childhood Cancer Survivors' Affective Response to Exercise
Official title: Childhood Cancer Survivors' Affective Response to Exercise
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ALL, Childhood
Acute Lymphoblastic Leukemia
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Implicit Association Bias Testing
timeFrame: Before and after Cardiovascular Stress Testing at Baseline
measure: Behavioral Regulation of Exercise Questionnaire (BREQ-2):
timeFrame: Before and after Cardiovascular Stress Testing at Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Megan Ware, MS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Jude Children's Research Hospital
name: Deo Srivastava, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Jude Children's Research Hospital
name: Lisa Jacola, PhD, ABPP-CN2
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Jude Children's Research Hospital
name: Rachel Webster, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Jude Children's Research Hospital
name: Tara Brinkman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Jude Children's Research Hospital
name: Kevin Krull, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Jude Children's Research Hospital
name: Melissa Hudson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Jude Children's Research Hospital
name: Leslie Robinson, PhD
role: PRINCIPAL_INVESTIGATOR
References: