The HEART Study (Healthy Eating and Recovery Together)

NCT ID: NCT04552587

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-04
• Study Completion Date: 2021-10-10

Brief Summary

Head and neck cancer survivors and their primary caregivers (N=25 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 (N=25 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.

Conditions

Head and Neck Cancer; Survivorship; Nutrition Aspect of Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

HEART

Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.

Group Type: EXPERIMENTAL

Heart APP

Intervention Type: BEHAVIORAL

The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support.

Interventions

Heart APP

The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 years and older
• Patients with stage I-IVB HNC of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers and cutaneous cancers of the head and neck region)
• In the last two weeks of treatment to 3 months following completion of primary treatment (i.e., any combination of surgery, chemotherapy and radiation therapy) within the past 3 months
• Experienced nutritional challenges at the end of treatment as assessed in a 6-item screener

• 18 years and older
• Provide care for a loved one with stage I-IVB head and neck cancer who has completed treatment

Exclusion Criteria

• head and neck cancer patients who do not undergo treatment
• Patients who do not read or understand English
• Patients who are cognitively impaired and cannot complete interviews, as judged by the referring health care provider
• Patients who do not have a smartphone for use in the study

• Caregivers who do not read or understand English
• Caregivers who are cognitively impaired and cannot complete interviews, as judged by the referring health care provider

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Katherine Sterba

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Sterba, PhD. MPH

Role: PRINCIPAL_INVESTIGATOR

Medical University of SC

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Patient Consent

View Document

Document Type: Informed Consent Form: Caregiver consent

View Document

Other Identifiers

R21CA215557-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0006621

Identifier Type: -

Identifier Source: org_study_id