Complementary Behavioral Interventions To Remediate Cognitive Impairment or Emotional Distress in Cancer Survivors

NCT06989463 | Active Not Recruiting

• 2 other identifiers: COPILOTNCI-2025-05387
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Survivors of Childhood Cancer

Outcome Measures

Primary Outcomes (3)

• Enrollment rate (%)

  The percentage of the number of participants approached for participation compared to those who enroll on study

  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

  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)

  Through study completion or an average of 24 months

Study Arms (2)

Exercise (EX) plus Cognitive Training (CT)

ACTIVE COMPARATOR

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

Exercise (EX) plus Mindfulness Practice (MP)

ACTIVE COMPARATOR

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

Interventions

Cognitive Training Intervention OTHER

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.

Exercise (EX) plus Cognitive Training (CT)

Mindfulness practice intervention OTHER

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.

Exercise (EX) plus Mindfulness Practice (MP)

12 Week Exercise Intervention OTHER

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.

Exercise (EX) plus Cognitive Training (CT); Exercise (EX) plus Mindfulness Practice (MP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants enrolled in St. Jude Lifetime Cohort (SJLIFE) \>18 years of age.
• Participant has been pre-identified as both physically impaired (T score ≤45 on the physical function and/or role physical subscales of the Medical Outcomes Survey Short Form 36 (SF-36)), and either cognitively (standard score \>84th percentile on the Childhood Cancer Survivor Study Neurocognitive Questionnaire) or emotionally impaired (T scored score ≥ 63 on the Brief Symptom Inventory) from the most recently completed SJLIFE survey questionnaires.
• Participant self-reports participating in \<150 minutes of moderate to vigorous physical activity per week (Centers for Disease Control Physical Activity Guidelines for Americans).
• Participant has been medically cleared to participate in physical activity.
• Participant verbalizing understanding of the directions to use the digital platform on provided laptop/tablet.

You may not qualify if:

• Participant cannot speak, read, and/or understand English.
• Participant is a woman and currently pregnant.
• Participant reports engaging in mindfulness-based training or continuously practiced mindfulness techniques over the past 6 weeks.
• Participant has an estimated intelligence score (FSIQ) \<80.
• Participant has a diagnosis of post-traumatic stress disorder, major psychiatric condition, and/or history of suicidal ideation or self-harm.
• Participant reports alcohol or drug abuse in the past year (Alcohol Use Disorders Identification Test (AUDIT) \>=13/women and \>=15/men or Drug Abuse Screen Test (DAST) -10\>3).

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• Description Clinical Trials Open at St. Jude

Study Officials

• Kirsten K Ness, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 25, 2025
• Study Start: July 29, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available at the time of article publication.
• Access Criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

Locations

US (1)