Pilot Evaluation of a Healthy Lifestyle Intervention for Adolescent and Young Adult Survivors of Pediatric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Change in Physical activity knowledge as assessed by the Knowledge of American Heart Association Physical Activity Recommendations Questionnaire
研究概览
简要总结
This is a feasibility and acceptability trial to test a newly developed healthy lifestyle intervention for adolescent and young adult survivors of pediatric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be adolescents and young adults (15-25 years of age) who have completed cancer treatment at Johns Hopkins All Children's Hospital any time in the last five years. This age range was chosen because it corresponds to the recommended age range for cancer-related adolescents and young adult studies
- •If the adolescent or young adult patient lives with a parent, other adult family member, or adult romantic/platonic partner, that person will also be invited to participate in the intervention as a support to the patient.
- •If the adolescent or young adult patient lives with a parent or romantic partner, the parent or romantic partner will also be invited to participate in the intervention as a support to the patient. A parent or romantic partner is eligible to participate if the patient lives with them at least 50% of the time. The parent or romantic partner will not receive separate financial compensation for participation. Herein, we use the word "parent" only because we expect the vast majority of patients will live with a parent instead of a romantic partner. Patients who do not live with a parent or romantic partner will participate alone.
- •The patient's cancer treatment must have included chemotherapy and/or radiation.
- •If a patient's cancer relapses during the study period, the patient's oncologist must agree to the patient continuing in this intervention.
排除标准
- •Potential participants who appear to have cognitive, motor, or language delays, as observed by research personnel or documented in the medical record, will be excluded from this study if delays preclude informed consent and/or study completion. Participants may request that research personnel read all assessment, education, and intervention materials aloud in a structured interview format, in which case participants could respond to items verbally and/or by pointing to visual aids. Because of this option, participants' ability to read and write are not requirements for participation.
- •Because the motivational interviewing component of the intervention is language-dependent and requires significant time and training for certification in another language, non-English speaking patients will only be included in this study if the psychology postdoctoral fellow hired in this study is a native Spanish speaker and can demonstrate motivational interviewing proficiency in Spanish.
结局指标
主要结局
Change in Physical activity knowledge as assessed by the Knowledge of American Heart Association Physical Activity Recommendations Questionnaire
时间窗: Pre-intervention and 2 months after the intervention concludes
Knowledge of physical activity recommendations, as evidenced by scores on the Knowledge of American Heart Association Physical Activity Recommendations Questionnaire (higher scores indicate greater knowledge).
Change in Physical activity as assessed by Fitbit data
时间窗: Pre-intervention and 2 months after the intervention concludes
Physical activity total weekly minutes, as evidenced by weekly Fitbit data (activity measured in minutes).
Change in Nutrition knowledge as assessed by the General Nutrition Knowledge Questionnaire
时间窗: Pre-intervention and 2 months after the intervention concludes
Knowledge of nutrition recommendations, as evidenced by scores on the General Nutrition Knowledge Questionnaire - Revised (higher scores indicate greater knowledge).
Change in Nutrition as assessed by the Rapid Eating Assessment for Patients score
时间窗: Pre-intervention and 2 months after the intervention concludes
Adherence to United States Department of Agriculture recommendations, as evidenced by the Rapid Eating Assessment for Patients (higher scores indicate better adherence to recommendations).
Intervention acceptability as assessed by the Abbreviated Acceptability Rating Profile
时间窗: Immediately following intervention
Patient and caregiver acceptability of the newly developed intervention, as evidenced by the Abbreviated Acceptability Rating Profile (higher scores indicate greater acceptability, with scores equal to or greater than 30 indicating good acceptability per published standards).
Intervention feasibility as assessed by the fidelity rating
时间窗: Immediately following intervention
Feasibility of conducting the intervention with high clinician fidelity, as evidenced by fidelity ratings for each session (fidelity represented as a percentage based on the extent to which the clinician covered all planned information for each session). Average intervention fidelity ratings should meet or exceed 80% fidelity.
次要结局
- Change in Healthy lifestyle self-efficacy as assessed by the Healthy Promoting Lifestyle Profile II(Pre-intervention and 2 months after the intervention concludes)
- Change in Healthy lifestyle self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire Short Form(Pre-intervention and 2 months after the intervention concludes)
- Change in Body satisfaction as assessed by the Body Esteem Scale for Adults and Adolescents(Pre-intervention and 2 months after the intervention concludes)
- Change in Anxiety as assessed by the PROMIS Anxiety Symptoms- Short Form(Pre-intervention and 2 months after the intervention concludes)
- Change in Depression as assessed by the PROMIS Depressive Symptoms-Short Form(Pre-intervention and 2 months after the intervention concludes)
- Change in Self-esteem as assessed by the Rosenberg Self Esteem Scale(Pre-intervention and 2 months after the intervention concludes)