Complementary Behavioral Interventions To Remediate Cognitive Impairment or Emotional Distress in Cancer Survivors: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Enrollment rate (%)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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) <
- •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).
研究组 & 干预措施
Exercise (EX) plus Cognitive Training (CT)
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
干预措施: 12 Week Exercise Intervention (Other)
Exercise (EX) plus Cognitive Training (CT)
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
干预措施: Cognitive Training Intervention (Other)
Exercise (EX) plus Mindfulness Practice (MP)
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.
干预措施: 12 Week Exercise Intervention (Other)
Exercise (EX) plus Mindfulness Practice (MP)
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.
干预措施: Mindfulness practice intervention (Other)
结局指标
主要结局
Enrollment rate (%)
时间窗: 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
Intervention adherence rate for those participants who complete the final follow up visit (%)
时间窗: Through study completion or an average of 24 months
The percentage of the intervention sessions attended v offered (n=24)
Follow up completion rate (%)
时间窗: 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
次要结局
未报告次要终点