Survivors of Childhood CancerCOPILOTNCT06989463
Complementary Behavioral Interventions To Remediate Cognitive Impairment or Emotional Distress in Cancer Survivors
A study testing 12 Week Exercise Intervention, Cognitive Training Intervention and Mindfulness practice intervention in people with Survivors of Childhood Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Survivors of Childhood Cancer
- What is being tested?
- 12 Week Exercise Intervention, Cognitive Training Intervention and Mindfulness practice intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Complementary Behavioral Interventions To Remediate Cognitive Impairment or Emotional Distress in Cancer Survivors: A Pilot Study
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.
Read more
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.
Read the 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
- Being tested
- 12 Week Exercise Intervention, Cognitive Training Intervention, Mindfulness practice intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 Week Exercise InterventionOther
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.
Cognitive Training InterventionOther
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.
Mindfulness practice interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: 12 Week Exercise Intervention; Other: Mindfulness practice intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate (%)
The percentage of the number of participants approached for participation compared to those who enroll on study
Measured: 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
Measured: 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)
Measured: Through study completion or an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start29 Jul 2025
- Primary completion17 Apr 2026
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survivors of Childhood CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten K Ness, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989463
- Sponsor's protocol ID
- COPILOT
- Other IDs
- NCI-2025-05387
- Acronym
- COPILOT
- Status last verified
- Jun 2026
- First submitted
- 8 May 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the ClinicalTrials.gov (CTG) website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Behavioral Interventions To Remediate Cognitive Impairment or Emotional Distress in Cancer Survivors: A Pilot Study
- ClinicalTrials.gov ID
- NCT06989463
- Acronym / sponsor ID
- COPILOT / COPILOT
- Conditions
- Survivors of Childhood Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise (EX) plus Cognitive Training (CT) | Active comparator | Other: 12 Week Exercise Intervention, Other: Cognitive Training InterventionAdult 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 |
| Exercise (EX) plus Mindfulness Practice (MP) | Active comparator | Other: 12 Week Exercise Intervention, Other: Mindfulness practice interventionAdult 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12 Week Exercise InterventionParticipants 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 | Exercise (EX) plus Cognitive Training (CT), Exercise (EX) plus Mindfulness Practice (MP) |
| Cognitive Training InterventionParticipants 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 | Exercise (EX) plus Cognitive Training (CT) |
| Mindfulness practice interventionThe 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. | Other | Exercise (EX) plus Mindfulness Practice (MP) |
Primary outcome
Enrollment rate (%)
Time frame: Through study completion or an average of 24 months
The percentage of the number of participants approached for participation compared to those who enroll on study
Follow up completion rate (%)
Time frame: Through study completion or an average of 24 months
The percentage of the number of participants who complete the 12-week testing compared to who enroll on study
Intervention adherence rate for those participants who complete the final follow up visit (%)
Time frame: Through study completion or an average of 24 months
The percentage of the intervention sessions attended v offered (n=24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Description Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the ClinicalTrials.gov (CTG) website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten K Ness, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 Week Exercise Intervention, Cognitive Training Intervention and Mindfulness practice intervention in people with Survivors of Childhood Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (%) (time frame: Through study completion or an average of 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.