The HEART Study (Healthy Eating and Recovery Together)

NCT04552587 | Completed Results

• 2 other identifiers: 0006621R21CA215557-02
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Survivorship; Nutrition Aspect of Cancer

Keywords

mHealth; Head and Neck Cancer; Survivorship; Caregiver

Outcome Measures

Primary Outcomes (3)

• Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria

  Investigator developed questionnaire investigating acceptability of session intervention and care plan. Items were rated on a 6-point descriptive scale from strongly disagree to strongly agree. Participants that meet criteria are those that chose moderately or strongly agree. Items included: Session made me feel prepared, care plan information was helpful emotionally, care plan was helpful practically, amount of information in care plan provided was appropriate, timing of session of session was appropriate.

  6 week follow-up visit

• Intervention Delivery/ Fidelity

  Number of caregivers receiving all session content and delivery of the intervention as planned (intro to session, nurse care plan discussion, viewed nutritional support video, app training).

  6 week follow up visit

• Intervention Reach

  Percentage of those recruited who completed baseline and 6 week follow up surveys and the intervention session.

  Baseline and 6 week follow up visit

Secondary Outcomes (16)

• Ease of Use/System Usability

  6 week follow up visit only (no baseline comparison)

• Mean Score of Unmet Needs

  Baseline and 6 week follow up visit

• PROMIS Depression- Short Form (SF) v1.0 Form 8A

  Baseline and 6 week follow-up visit

• Mean Score of Survivorship Readiness/Caregiver Preparedness

  Baseline and 6 week follow-up visit

• Mean Score of Self-Efficacy

  Baseline and 6 week follow-up visit

Study Arms (1)

HEART

EXPERIMENTAL

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.

Behavioral: Heart APP

Interventions

Heart APP 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.

HEART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Katherine R. Sterba, PhD, MPH
• Organization: Medical University of South Carolina

sterba@musc.edu

843- 876-2419

Study Officials

• Katherine Sterba, PhD. MPH

  Medical University of SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 17, 2020
• Study Start: December 4, 2020
• Primary Completion: October 10, 2021
• Study Completion: October 10, 2021
• Last Updated: January 20, 2023
• Results First Posted: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)