Clinical trial NCT06989463: Complementary Behavioral Interventions To Remediate Cognitive Impairment or Emotional Distress in Cancer Survivors
Official title: Complementary Behavioral Interventions To Remediate Cognitive Impairment or Emotional Distress in Cancer Survivors: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Survivors of Childhood Cancer
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Enrollment rate (%)
timeFrame: Through study completion or an average of 24 months
measure: Follow up completion rate (%)
timeFrame: Through study completion or an average of 24 months
measure: Intervention adherence rate for those participants who complete the final follow up visit (%)
timeFrame: Through study completion or an average of 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Kirsten K Ness, PhD
role: PRINCIPAL_INVESTIGATOR
References: