Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors (NOURISH-T)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 4
- 主要终点
- Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE
研究概览
简要总结
This purpose of this pilot study is to investigate the feasibility of and optimal time post cancer treatment to offer caregivers a new health behavior change intervention (NOURISH-T), as well as assess its preliminary efficacy on specific child health behaviors. The study will also explore whether caregivers NOURISH-T exhibit more improvements than caregivers in EUC (standard care).
详细描述
Approximately 40% of off-treatment pediatric cancer survivors (PCS) are overweight or obese, which increases their risk for negative long-term physical health complications. Consistent with the Institute of Medicine's (IOM) emphasis on patients transitioning from treatment to cancer survivorship and increasing long-term healthy behaviors in these survivors, we conducted a pilot RCT to address the increasing overweight/obesity rates among PCS by targeting their caregivers as agents for PCS behavior change. We focused on parents' behaviors, attitudes and roles in promoting healthier eating and physical activity (PA) in PCS and adapted an evidence-informed, manualized parent intervention - NOURISH - found to be effective for parents of overweight and obese children and adolescents in reducing child and adolescent BMI. We adapted NOURISH for caregivers of 5 - 13 year old PCS (6 months -4 years off active cancer treatment). Our pilot feasibility RCT - NOURISH-T (Nourishing Our Understanding of Role modeling to Improve Support for Healthy Transitions) evaluates: 1) the preliminary feasibility efficacy of NOURISH-T for PCS, compared with an Enhanced Usual Care (EUC) control condition, and 2) factors to consider to improve future adaptations of the intervention. The project enrolled caregivers of PCS at two pediatric oncology clinics into the 6-week intervention (or EUC) with assessments of both caregivers and PCS occurring pre- and post-6 weeks of intervention, and at a 4-month follow-up. In comparison to EUC, we hypothesized that caregivers and PCS assigned to the NOURISH-T condition would show greater improvements in dietary intake, physical activity, and in anthropometric health indicators over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mothers and fathers (biologic/adoptive/step parents/legal guardians) of pediatric cancer survivors
- •18 years or older
- •Fluent in English
- •Pediatric Cancer Survivors
- •Diagnosis of cancer
- •between 5-13 years of age at study entry
- •off active cancer treatment for 6 months to 4 years,
- •reside with a participating caregiver
- •able to engage in PA tailored to current medical status
- •NOT taking medications that affect body weight, e.g., steroids within 6 months of enrollment
- •at or above the 85th BMI %ile.
排除标准
- •are non-ambulatory
- •do not reside with the PCS at least 50% of the time.
- •Pediatric cancer survivor
- •relapse during the intervention
- •taken a medication known to affect body weight such as oral steroids or antipsychotic medications within 6 months of enrollment
结局指标
主要结局
Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE
时间窗: 6 weeks
At the end of the final session (6-sessions), caregivers completed a likert-type survey assessing what they liked/disliked about the intervention, as well as what was/was not useful or helpful in reaching health goals. Eleven items were summed to obtain a total continuous composite satisfaction/liking score. Each item was measured on a likert scale ranging from strongly disagree (=1) to strongly agree (=5). The scale sum score ranged from 11 to 55 with higher scores indicating greater satisfaction with the intervention. More specifically, the higher the score, the more useful the caregiver thought the intervention and the more they liked participating in the intervention. Lower scores indicate that the caregiver thought the program was not useful and they did not like participating.
次要结局
- Automated Self-administered 24-Hour Dietary Recall (ASA 24) -- CAREGIVERS ONLY MEASURE(Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months))
- Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure(Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months))
- Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE(Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months))
- Parent BMI Score -- CAREGIVER MEASURE(Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months))
- Number of Daily Steps Averaged Over a Week for Caregivers -- CAREGIVER MEASURE(Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months))
- Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed(Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months))
- Parent Waist to Hip Ratio -- CAREGIVER MEASURE(Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months))
- Child Waist to Hip Ratio -- ONLY Pediatric Cancer Survivors (PCS) ASSESSED(Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months))
- Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS)(Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months))