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

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

Interventions

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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Kirsten K Ness, PhD · St. Jude Children's Research Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-29

Primary Completion

2026-05-31

Completion

2026-11-30

Countries

• United States

Study Locations