Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04552587
Status:
COMPLETED
Last Update Posted:
2023-01-20
First Post:
2020-09-03
Brief Title:
The HEART Study Healthy Eating and Recovery Together
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
A Mobile-Support Program to Facilitate Nutritional Caregiving in Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Head and neck cancer survivors and their primary caregivers N25 dyads will be enrolled to pilot test a nutrition support system with a care planning clinic visit and a caregiver mobile App Participants will be asked to complete baseline and 6-week follow-up surveys The clinic session offered in person or remotely will include a needs assessment and a tailored care plan with information educational materials and referrals about participants symptoms behaviors social concerns and caregiving tasks After the visit the program will provide an App for caregivers with follow-up resources and mobile support for one month
Detailed Description:
The long-term goal of this research is to improve physical emotional and social post-treatment outcomes in head and neck cancer survivors and caregivers by implementing a nutrition-focused mobile-Support program to prepare and support caregivers after treatment
Head and neck cancer survivors and their primary caregivers N25 dyads will be recruited to a single-arm intervention study to evaluate the feasibility acceptability and short-term effects of a nutrition-focused mobile support system The intervention includes 1 a clinic visit offered in-person or virtually with a tablet-based needs assessment at the end of or after completing treatment which will generate 2 a tailored care plan with messages educational materials and referrals mapped to survivor and caregiver-endorsed concerns and 3 a caregiver App with encouragement reminders and tips delivered through messaging and peer videos Participants will complete baseline and 6-week follow-up surveys
Head and neck cancer survivors and their primary caregivers N25 dyads will be recruited to a single-arm intervention study to evaluate the feasibility acceptability and short-term effects of a nutrition-focused mobile support system The intervention includes 1 a clinic visit offered in-person or virtually with a tablet-based needs assessment at the end of or after completing treatment which will generate 2 a tailored care plan with messages educational materials and referrals mapped to survivor and caregiver-endorsed concerns and 3 a caregiver App with encouragement reminders and tips delivered through messaging and peer videos Participants will complete baseline and 6-week follow-up surveys
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21CA215557-02 | NIH | None | httpsreporternihgovquickSearchR21CA215557-02 |