NCT06989463

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

Complementary Behavioral Interventions To Remediate Cognitive Impairment or Emotional Distress in Cancer Survivors: A Pilot Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Survivors of Childhood Cancer

Interventions

Type	Name	Description
OTHER	12 Week Exercise 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.
OTHER	Cognitive Training Intervention	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.
OTHER	Mindfulness practice intervention	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.

Timeline

• Start date: 2025-07-29
• Primary completion: 2026-05-01
• Completion: 2026-11-01
• First posted: 2025-05-25
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States