A Healthy Weight Intervention for Family Stress During the Early Phases of ALL Treatment: NOURISH-ALL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Recruitment Rate
研究概览
简要总结
The purpose of this study is to conduct a single arm pilot of the NOURISH-ALL (Nourishing Our Understanding of Role modeling to Improve Support and Health in Acute Lymphoblastic Leukemia) intervention focused on three components of participant engagement. This is a single arm intervention study that involves participation in a 6-session family intervention and three time points of multimethod data collection. The primary outcome is participant engagement, measured as recruitment, retention, and intended dose received.
This study will be conducted over 5 years in three phases:
- Aim 1a: Adapting the NOURISH-ALL Intervention for Families of Youth with ALL (Year 1)
- Aim 1b: Iteratively Refining the NOURISH-ALL Intervention (Year 2)
- Aim 2: Pilot Single-Arm Trial of NOURISH-ALL Focused on Participant Engagement (Years 3-5)
详细描述
The long-term goal of this work is to establish an efficacious family-based health promotion intervention that curbs excessive weight gain among youth with newly diagnosed acute lymphoblastic leukemia (ALL) by integrating support for family coping with stress during the early phases of treatment.
The objectives of the current study are to adapt an existing family-based health promotion intervention, NOURISH-T, to meet the needs of families of youth in the early phases of ALL treatment (NOURISH-ALL) and (2) assess three key components of engagement in preparation for a fully powered efficacy trial.
NOURISH-T is a 6-session family-based health promotion intervention that has demonstrated improved physical activity (PA), dietary intake, and weight among youth who are cancer survivors. Guided by the ORBIT Model of Behavioral Intervention Development, this study will modify NOURISH-T to fit the early ALL treatment context through a multi-stage adaptation and refinement process. Adaptations will incorporate family systems and cognitive behavioral intervention components to support healthy family coping with diagnosis and treatment stress. Additional, patient-centered adaptations will be informed by semi-structured family input around intervention content and delivery.
The central hypothesis is that this rigorous approach to adaptation will yield an intervention that is feasible, acceptable, and engaging for families of youth with ALL. By incorporating tailored strategies for health promotion during the early phases of ALL treatment, the proposed study seeks to shift clinical practice paradigms to prevent weight-related disparities in treatment outcomes.
Hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 2-12 years old and their primary caregiver ages 18-90
- •Child diagnosed with acute lymphoblastic leukemia (ALL)
- •Child completed induction phase of therapy and not yet in maintenance phase of therapy
- •Primary caregiver and child English language proficient
- •Primary caregiver able to provide permission for child to participate in research
- •Primary caregiver identifies as being involved with child's oncology care
- •Primary caregiver lives with child at least 50% of the time
- •Primary oncology provider confirms child is eligible to participate
排除标准
- •Primary oncology provider identifies safety concerns regarding the child's participation in the study.
研究组 & 干预措施
Aim 2: Pilot Single-Arm Trial of NOURISH-ALL Focused on Participant Engagement (Years 3-5)
Pilot testing key components of engagement is critical to optimizing design and methodology of fully powered efficacy trials. The purpose of Aim 2 is to pilot a single-arm trial of the finalized NOURISH-ALL intervention in a sample of families of youth in the early phases of ALL treatment to assess recruitment, retention, and dose received. Results will directly inform the design of the fully powered randomized control trial to test intervention efficacy (R01 application to be submitted in Year 4).
干预措施: NOURISH-ALL (Behavioral)
结局指标
主要结局
Recruitment Rate
时间窗: Baseline (Week 0)
Measured by # enrolled / # eligible
Retention Rate
时间窗: Post-Intervention (Week 6), Follow-Up (Month 6)
Measured by # completed intervention / # enrolled
Intended dose received
时间窗: Post-Intervention (Week 6), Follow-Up (Month 6)
Measured by # sessions attended / # sessions offered
次要结局
- Child Body Mass Index (BMI)(Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6))
- Child Physical Activity(Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6))
- Child Sleep(Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6))
- Child Dietary Intake(Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6))
- Family Stress Measures(Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6))
- Family Distress(Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6))
- Body Composition - Bioelectrical Impedance Analysis(Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6))
- Body Composition(Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6))
- Subcutaneous fat(Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6))
研究者
Carolyn Bates, PhD
Principal Investigator, Assistant Professor
University of Kansas Medical Center