Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523322
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Culinary Medicine for Cancer Caregivers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Culinary Medicine for Caregivers Improving Pediatric Cancer Patient and Caregiver Outcomes Through Nutrition and Culinary Support
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 Lets 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 Childrens 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 programs 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 intakebehaviors Results from the feasibility pilot including qualitative feedback will be used to guide the interpretation of findings refine the study methodology and Lets 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None