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Active Not Recruiting
NCT06989463
Complementary Behavioral Interventions To Remediate Cognitive Impairment or Emotional Distress in Cancer Survivors
Conditions: Survivors of Childhood Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: St. Jude Children's Research Hospital
Location: St. Jude Children's Research Hospital Memphis Tennessee
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.
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 \=15/men or Drug Abuse Screen Test (DAST) -10\>3).
Source: ClinicalTrials.gov (NCT06989463). StuddyBuddy aggregates publicly available trial information.