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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adult survivors of childhood cancer can engage in two activities simultaneously to benefit their health. The activities combine exercise with either brain training or mindfulness, which focuses on being present. These interventions complement each other behaviorally. The trial targets individuals experiencing mental or emotional challenges after cancer treatment. Participants should belong to the St. Jude Lifetime Cohort, not be currently very active, and be able to use a digital platform for the activities. As an unphased trial, this study provides a unique opportunity to explore innovative methods for enhancing mental and emotional well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these behavioral interventions are safe for childhood cancer survivors?

Research has shown that exercise programs, combined with either brain training or mindfulness, are safe for children who have survived cancer. Studies have found that exercise can boost both physical and mental health. For instance, one study discovered that exercise improved muscle strength and was well-received by participants. Another study showed that physical activity enhanced both physical and emotional well-being for those who had cancer as children.

Mindfulness practices, like meditation, have also been researched in this group. They are considered safe and can help reduce stress and feelings like anxiety and sadness. Research has found that mindfulness can be especially helpful for managing tiredness and emotional distress.

Overall, combining exercise with either brain training or mindfulness has been well-received. Previous studies have reported no major safety issues. This suggests that these activities are safe for childhood cancer survivors who want to improve their health and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these behavioral interventions for childhood cancer survivors because they uniquely combine exercise with cognitive or mindfulness training to target cognitive and emotional impairments, which are common challenges for survivors. Unlike standard treatments that might focus solely on medication or counseling, these interventions aim to enhance brain function and emotional well-being through physical activity and mental exercises. By integrating exercise with cognitive training, the approach could improve memory and attention, while the combination with mindfulness practice may help reduce stress and enhance emotional resilience. This holistic approach offers a promising alternative to traditional therapies, potentially leading to more comprehensive and lasting improvements in quality of life for survivors.

What evidence suggests that this trial's interventions could be effective for childhood cancer survivors?

This trial will compare two different behavioral interventions for adult survivors of childhood cancer. One treatment arm involves Exercise (EX) combined with Cognitive Training (CT), which research shows can improve thinking skills, such as memory, focus, and decision-making. Exercise alone also reduces cancer-related fatigue, a common issue for survivors.

The other treatment arm involves Exercise (EX) combined with Mindfulness Practice (MP). Practicing mindfulness, especially with exercise, helps people manage stress better, become more resilient, and improve their overall quality of life. Mindfulness programs have successfully lowered stress and anxiety in cancer patients. Combining exercise and mindfulness may offer a comprehensive approach to addressing both mental and emotional challenges that survivors face. ^{2 5 6 7 8}

Who Is on the Research Team?

Kirsten K Ness, PhD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7556245/

Effects of Cognitive Training and Exergaming in Pediatric ... Home-based computerized working memory training programs are feasible and effective in improving cognitive skills in pediatric cancer survivors (11,12).

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352464222002863

Physical activity and exercise for cancer-related cognitive ... Systematic reviews have shown that physical activity interventions might improve physical and psychosocial outcomes in individuals affected by childhood cancer, ...

3. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-017-3933-x

The Brainfit study: efficacy of cognitive training ... - BMC Cancer The aim of the present clinical trial is to extend empirical evidence about efficacy of cognitive and physical training in pediatric cancer survivors.

4. journals.lww.com journals.lww.com/cancerjournal/fulltext/2022/18070/meta_analysis_of_neurocognitive_rehabilitation_for.31.aspx

Meta-analysis of neurocognitive rehabilitation for cognitive ... This meta-analysis found that neurocognitive rehabilitation interventions improve the working memory, attention, and executive functioning of pediatric cancer ...

5. link.springer.com link.springer.com/article/10.1007/s11764-020-00981-w

Physical activity for pediatric cancer survivors: a systematic ... The study found that the program was effective in reducing cancer-related fatigue among Chinese pediatric cancer survivors [33].

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10048410/

Effects of Exercise and Physical Activity Levels on Childhood ... Exercise interventions had a positive effect on many physiological and psychological health outcomes in pediatric cancer patients and survivors.

7. cancer.jmir.org cancer.jmir.org/2016/1/e6/

The Effects of Physical Activity on Health and Quality of Life in ... Behavioral and social outcomes in adolescent survivors of childhood cancer: a report from the childhood cancer survivor study. J Clin Oncol ...

8. mdpi.com mdpi.com/2227-9067/9/6/824

Supervised Exercise Interventions in Childhood Cancer ... The results demonstrated that supervised exercise interventions had high retention and adherence rates, which could significantly improve muscle ...