Behavioral Interventions for Childhood Cancer Survivors

(COPILOT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Pregnancy, PTSD, Major psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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 • To determine the acceptability of a two-component intervention (exercise (EX) plus cognitive training (CT) or exercise (EX) plus mindfulness practice (MP)) among survivors of childhood cancer with either cognitive impairment or emotional distress. Hypotheses: * 45% of those approached for participation in each arm of this study will enroll on the study. * Among those who enroll, 70% will complete the follow-up testing at 12 weeks. * Among those who completed the follow-up testing, the mean attendance to the intervention sessions will be 70% on each of their two interventions. That is, they will complete 70% of exercise sessions and 70% of either cognitive training or mindfulness practice. * To identify barriers and facilitators to intervention adherence. Hypotheses: * Participants will identify features of the study processes that either facilitate or discourage adherence. * Participants will identify features of the intervention technology and intervention components that either facilitate or discourage adherence. * Participants will identify personal factors that facilitate or discourage adherence.

Research Team

Kirsten K Ness, PhD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for adult survivors of childhood cancer who are part of the St. Jude Lifetime Cohort (SJLIFE) and may be experiencing cognitive impairment or emotional distress. Participants will engage in two interventions simultaneously over a 12-week period.

Inclusion Criteria

Participant verbalizing understanding of the directions to use the digital platform on provided laptop/tablet.

Participant self-reports participating in less than 150 minutes of moderate to vigorous physical activity per week (Centers for Disease Control Physical Activity Guidelines for Americans)

Participant medically cleared to participate in physical activity

Exclusion Criteria

Participant unable to speak, read, and/or understand English

Participant is a pregnant woman

Participant has an estimated intelligence score (FSIQ) less than 80

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week intervention of exercise plus cognitive training or exercise plus mindfulness practice

12 weeks

Remote assessments before and after the intervention period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Complementary Behavioral Interventions

Trial Overview The study tests the acceptability and effectiveness of combining exercise with either cognitive training or mindfulness practice to improve mental function and emotional well-being in cancer survivors. It aims to see if participants can adhere to both interventions at once.

Participant Groups

Group I: Exercise (EX) plus Cognitive Training (CT) Active Control 2 Interventions

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

Group II: Exercise (EX) plus Mindfulness Practice (MP) Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+