An interventional study of 12 Week Exercise Intervention and Cognitive Training Intervention in Survivors of Childhood Cancer, sponsored by St. Jude Children's Research Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by St. Jude Children's Research Hospital · Not applicable, Interventional, and Supportive care
Childhood cancer survivors are at risk for accelerated aging due to the specific treatments they have received to cure their cancer. Several interventions, including exercise, cognitive training, and mindfulness practice, have been developed and studied for effectiveness among participants in the St. Jude Lifetime Cohort (SJLIFE) to mitigate these effects. The interventions offered thus far have not included two components at the same time.
The purpose of this study is to determine whether or not adult cancer survivors enrolled in SJLIFE will participate in two interventions at the same time. The combined interventions will include exercise plus cognitive training or exercise plus mindfulness practice. Each intervention will be conducted over a 12-week period. Participants will also be asked to complete follow-up testing after the 12-week intervention period is completed.
Primary Objectives
Hypotheses:
Hypotheses:
The study will recruit survivors from the SJLIFE cohort who have completed a recent SJLIFE campus visit and were pre-identified as either cognitively (by self-report on Childhood Cancer Survivor Study (CCSS) NCQ) or emotionally impaired (by self-report on the BSI). We plan to recruit 10 survivors from each impairment group. All survivors will be at least five years from diagnosis.
Participants will be assigned to one of two interventions - 1) (exercise (EX) plus cognitive training (CT) or 2) exercise (EX) plus mindfulness practice (MP).
Those pre-identified as cognitively impaired will be assigned to the EX+CT arm and those pre-identified as emotionally impaired will be assigned to the EX+MP arm.
The make up in each of the two study interventions will include 3 survivors aged 18-29 years, 4 survivors aged 30-39 years, and 3 survivors aged 40 years or older. Additionally, each intervention will include 5 males and 5 females and at least 4 survivors that report either non-Hispanic black or Hispanic race/ethnicity.
Potentially eligible participants have already been screened for physical, cognitive, and emotional impairments based on data previously collected at a recent SJLIFE campus visit. All participants identified will engage in \<150-minutes/week of moderate/vigorous physical activity and are either cognitively or emotionally impaired (as indicated on a recently completed neurocognitive or emotional health questionnaire).
Each arm will participate in a 12-week intervention period. All participants will receive the necessary equipment to complete the remote assessments (e.g., pregnancy test if female, laptop configured with access to exercise platform, cognitive training and mindfulness practice materials, pulse oximeter, blood pressure monitor, etc.) as well as exercise equipment (e.g., exercise mat, resistance bands). Each participant will complete a remote assessment before and after the intervention period.
All participants will receive an individually tailored exercise prescription, written by an exercise specialist and approved by the study physician. The prescription will include aerobic and strengthening components designed to progress the participants gradually to 150-300 minutes of the equivalent of moderate aerobic activity and twice weekly strengthening over 12 weeks.
Participants assigned to cognitive training will use a computer-based training which consists of games focused on specific executive function skills (shifting attention, working memory, verbal fluency, problem solving). Participants will be prescribed three 20-minute sessions each week for 12-weeks.
St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adult survivor of childhood cancer enrolled in St. Jude Life Cohort (SJLIFE) at least five years from diagnosis. Participants pre-identified as cognitively impaired will be assigned to the EX+CT arm
Other: 12 Week Exercise Intervention · Other: Cognitive Training Intervention
Adult survivor of childhood cancer enrolled in St. Jude Life Cohort (SJLIFE) at least five years from diagnosis. Participants pre-identified as emotionally impaired will be assigned to the EX+MP arm.
Other: 12 Week Exercise Intervention · Other: Mindfulness practice intervention
Participants will be provided with the results of their physical functioning and fitness assessments and will receive an individually tailored exercise prescription, written by an exercise specialist and approved by the study physician. The prescription will include aerobic and strengthening components designed to progress persons gradually to 150-300 minutes of the equivalent of moderate aerobic activity and twice weekly strengthening106 over 12 weeks.
Participants will complete cognitive training with Lumosity (Lumos Labs, Inc.; San Francisco, California; cognitive training program). This computer-based training consists of games focused on specific executive function skills (shifting attention, working memory, verbal fluency, problem solving). Each 20-minute session includes five games focused specifically on these executive functioning skills. Participants will be prescribed three 20-minute sessions each week for 12-weeks.
The mindfulness practice intervention is a modified version of the University of California at Los Angeles Mindfulness Awareness Research Center's Mindful Awareness Practices designated to be remotely delivered. during odd weeks, participants will watch the educational lecture video once and practice meditation daily. During even weeks, they will review the educational video as needed and continue daily meditation practice.
Enrollment rate (%)
The percentage of the number of participants approached for participation compared to those who enroll on study
Time frame: Through study completion or an average of 24 months
Follow up completion rate (%)
The percentage of the number of participants who complete the 12-week testing compared to who enroll on study
Time frame: Through study completion or an average of 24 months
Intervention adherence rate for those participants who complete the final follow up visit (%)
The percentage of the intervention sessions attended v offered (n=24)
Time frame: Through study completion or an average of 24 months
Plan to share: Yes — Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the ClinicalTrials.gov (CTG) website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Supporting information: Study protocol, Sap, Icf
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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St. Jude Children's Research Hospital