NCT05763290

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
46mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Mar 2023Feb 2030

First Submitted

Initial submission to the registry

February 22, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

March 22, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

February 22, 2023

Last Update Submit

April 21, 2026

Conditions

ALL, ChildhoodAcute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

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.

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Ware, MS, PhD

CONTACT

888-226-4343referralinfo@stjude.org

Kirsten Ness, PhD

CONTACT

888-226-4343referralinfo@stjude.org

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 10, 2023

Study Start

March 22, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2030

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

US(1)