Culinary Medicine for Caregivers: Improving Pediatric Cancer Patient and Caregiver Outcomes Through Nutrition and Culinary Support
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Perceived usefulness as assessed by the extent to which the session was useful in helping participants to increase their confidence, overcome barriers, and increase the support they receive.
研究概览
简要总结
Pediatric cancer and the therapies used in treatment can affect nutritional status, which can impact treatment tolerance, survival, and overall well-being. Poorly managed side effects can lead to long-term poor dietary habits. Caregivers who endure the psychosocial toll of these effects, also face risks to their own well-being. Prioritizing interventions that enhance caregivers' ability to provide quality care and improve long-term health is crucial. The primary aim of this study is to determine the feasibility and acceptability of an 8-week culinary medicine intervention with caregiver coaching for caregivers of children undergoing cancer treatment. The secondary aim is to estimate the effect of the intervention on caregiving preparedness, caregiver self-confidence for managing patient treatment side effects, eating-related distress, and dietary intake. In-depth interviews will explore participant experiences and perspectives on the feasibility and acceptability of the culinary nutrition program, and to inform interpretation of findings and future program refinement.
详细描述
Pediatric cancer and the therapies used in treatment can affect nutritional status, which can then impact treatment tolerance, survival, and overall well-being. Poorly managed side effects can lead to long-term poor dietary habits. Caregivers who endure the psychosocial toll of these effects, also face risks to their own well-being. Prioritizing interventions that enhance caregivers' ability to provide quality care and improve long-term health is crucial. Culinary medicine interventions have demonstrated efficacy in boosting cooking confidence and dietary quality as well as providing positive benefits to help with cancer treatment side effects. The investigators developed an 8-week culinary nutrition program incorporating caregiver coaching to enhance outcomes for pediatric cancer patients and their caregivers. Let's Cook Together aims to increase caregiver knowledge of a whole foods approach to eating, enhance preparedness for caregiving, and boost caregiver self-efficacy for managing side effects. Caregivers with children undergoing cancer treatment will be recruited from the Children's Hospital of Philadelphia. The program includes four remote cooking sessions led by a Medical Chef Educator and a Registered Dietitian Nutritionist, and bi-weekly coaching sessions to discuss caregiving goals, challenges, and problem-solving strategies. Written resources including nutrition education and recipes will be provided to all study participants. A single-arm mixed-methods feasibility study will assess the program's viability. Participants will undergo assessments at baseline, post-intervention, and three months post-intervention, with qualitative interviews post-intervention. The primary goal is to evaluate feasibility and acceptability, while secondary objectives include assessing preliminary efficacy on caregiving preparedness, caregiver self-efficacy, pediatric feeding behaviors, and dietary intake/behaviors. Results from the feasibility pilot, including qualitative feedback, will be used to guide the interpretation of findings, refine the study methodology and Let's Cook Together program, and inform the design of an adequately powered definitive trial. Findings may be of interest to a broad range of oncology and allied health professionals engaged in supportive care for families experiencing cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •*Please note the above age limit and 'accepts health volunteers' specifications are related to the caregiver as the participant. Additional age limit criteria for patient is listed below. All caregivers will be providing care for a child undergoing current cancer treatment.
- •Inclusion Criteria, Patient:
- •Receiving active cancer treatment for a liquid or solid cancer diagnosis
- •At least 4-17 years of age
- •English-speaking
- •Taking >50% intake orally
- •Approved to participate by both their oncologist and registered dietitian nutritionist
排除标准
- •Undergoing bone marrow transplantation
- •Receiving active cancer treatment for a brain tumor
- •Inclusion Criteria, Caregiver:
- •Caregiver (parent or legal guardian) of a child who meets the inclusion and exclusion criteria for patients, above
- •Can read and speak English
- •Has access to a computer (i.e., tablet, laptop, desktop computer) and internet
- •Is at least 18 years of age
- •Has the ability to provide informed consent
研究组 & 干预措施
Culinary Medicine plus Caregiver Coaching
8-week culinary medicine program, including 4 biweekly culinary medicine workshops and biweekly caregiver coaching.
干预措施: Let's Cook Together (Behavioral)
结局指标
主要结局
Perceived usefulness as assessed by the extent to which the session was useful in helping participants to increase their confidence, overcome barriers, and increase the support they receive.
时间窗: During the intervention; immediately after the intervention; and 3-months after the intervention
Perceived usefulness will be measured along a 5-point Likert scale to questions ask the extent to which the session was useful in helping participants to increase their confidence, overcome barriers, and increase the support they receive. Perceived usefulness will be expressed as the percent of participants who rate each of the previous domains as 'agree' or 'strongly agree.'
Acceptability of the intervention as assessed by comprehension of intervention content, personal relevance, and appropriate information volume.
时间窗: During the intervention; immediately after the intervention; and 3-months after the intervention
Acceptability will be measured along a 5-point Likert scale to questions that ask whether the culinary medicine information was easy to understand, personally relevant, and whether the amount of information presented was appropriate. Intervention acceptability will be expressed as the percent of participants who rate each of the previous domains as 'agree' or 'strongly agree.'
Usage of the intervention as assessed by the number of recipes used.
时间窗: During the intervention; immediately after the intervention; and 3-months after the intervention
Usage will be measured according to the number of recipes used.
Usability of the intervention as assessed by ease of use and plan for continued use.
时间窗: During the intervention; immediately after the intervention; and 3-months after the intervention
Usability will be measured along a 5-point Likert scale to questions that ask participants the extent to which the recipes were easy to use and plan for continued use. Intervention usability will be expressed as the percent of participants who rate each of the previous domains as 'agree' or 'strongly agree.'
Feasibility of the intervention as assessed by participant session attendance, assessment completion, and participant retention.
时间窗: During the intervention; immediately after the intervention; and 3-months after the intervention
Objective metrics will be used to determine feasibility, including the number of participants enrolled per month of recruitment, the percent of participants who provide assessment data at 8 weeks, and the proportion of retained participants who provide valid data for each assessment task. The percent of participants who attend all sessions and complete all assessments will be used as a metric for feasibility.
次要结局
- Change from baseline in patient dietary intake (food groups, macronutrient, micronutrient, and caloric intake) as assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool(Baseline; immediately after the intervention; and 3-months after the intervention)
- Change from baseline in preparedness for caregiving as assessed by the Preparedness for Caregiving Scale.(Baseline; immediately after the intervention; and 3-months after the intervention)
- Change from baseline in caregiver self-efficacy to manage treatment-related side effects a assessed by the Caregiver Self-Efficacy for Management of Treatment Side Effects survey(Baseline; immediately after the intervention; and 3-months after the intervention)
- Change from baseline in caregiver dietary intake as assessed by the Inflammatory Diet Index.(Baseline; immediately after the intervention; and 3-months after the intervention)
- Change from baseline in caregiver eating-related distress as assessed by the Behavioral Pediatrics Feeding Assessment Scale.(Baseline; immediately after the intervention; and 3-months after the intervention)
研究者
Brandy-Joe Milliron
Associate Professor
Drexel University