ALL, ChildhoodNCT05763290
Childhood Cancer Survivors' Affective Response to Exercise
An observational study of ALL, Childhood and Acute Lymphoblastic Leukemia, run by St. Jude Children's Research Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- ALL, Childhood, Acute Lymphoblastic Leukemia
- What is being tested?
- Affective Response to Exercise
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2023to Feb 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- ALL, Childhood, Acute Lymphoblastic Leukemia
- Being tested
- Affective Response to Exercise
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affective Response to ExerciseOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Implicit Association Bias Testing
Participants' implicit associations with exercise will be measured using the Personalized Single-Category Implicit Association test (PSC-IAT).
Measured: Before and after Cardiovascular Stress Testing at Baseline
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.
Measured: Before and after Cardiovascular Stress Testing at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start22 Mar 2023
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALL, ChildhoodStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten Ness, PhD, Principal investigator, St. Jude Children's Research HospitalDeo Srivastava, PhD, Principal investigator, St. Jude Children's Research HospitalLisa Jacola, PhD, ABPP-CN2, Principal investigator, St. Jude Children's Research HospitalRachel Webster, PhD, Principal investigator, St. Jude Children's Research HospitalTara Brinkman, PhD, Principal investigator, St. Jude Children's Research HospitalKevin Krull, PhD, Principal investigator, St. Jude Children's Research HospitalMelissa Hudson, MD, Principal investigator, St. Jude Children's Research HospitalLeslie Robinson, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763290
- Sponsor's protocol ID
- CAREX
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No