Childhood Cancer Survivors' Affective Response to Exercise

Sponsor
St. Jude Children's Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05763290
Collaborator
(none)
125
1
8
15.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Affective Response to 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
125 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Childhood Cancer Survivors' Affective Response to Exercise
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Implicit Association Bias Testing [Before and after Cardiovascular Stress Testing at Baseline]

    Participants' implicit associations with exercise will be measured using the Personalized Single-Category Implicit Association test (PSC-IAT).

  2. Behavioral Regulation of Exercise Questionnaire (BREQ-2): [Before and after Cardiovascular Stress Testing at Baseline]

    The Behavioral Regulation of Exercise Questionnaire (BREQ-2) will be administered once to participants in this study to assess trait-level affective motivation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 IQ of <70 (measured at using the Wechsler Abbreviated Scale of Intelligence (WASI-II)

  • Individuals with any contraindication to stress testing (i.e. cardiovascular complications)

  • Women who are currently pregnant

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Jude Children's Research Hospital Memphis Tennessee United States 38105

Sponsors and Collaborators

  • St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Megan Ware, MS, PhD, St. Jude Children's Research Hospital
  • Principal Investigator: Deo Srivastava, PhD, St. Jude Children's Research Hospital
  • Principal Investigator: Lisa Jacola, PhD, ABPP-CN2, St. Jude Children's Research Hospital
  • Principal Investigator: Rachel Webster, PhD, St. Jude Children's Research Hospital
  • Principal Investigator: Tara Brinkman, PhD, St. Jude Children's Research Hospital
  • Principal Investigator: Kevin Krull, PhD, St. Jude Children's Research Hospital
  • Principal Investigator: Melissa Hudson, MD, St. Jude Children's Research Hospital
  • Principal Investigator: Leslie Robinson, PhD, St. Jude Children's Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT05763290
Other Study ID Numbers:
  • CAREX
First Posted:
Mar 10, 2023
Last Update Posted:
Mar 10, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2023