CompletedNot Applicable

The HEART Study (Healthy Eating and Recovery Together)

United States51 participantsStarted 2020-12-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Patient 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 Patient 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 Caregiver Inclusion Criteria: * 18 years and older * Provide care for a loved one with stage I-IVB head and neck cancer who has completed treatment Caregiver Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 week follow-up visit

Intervention Delivery/ Fidelity

Timeframe: 6 week follow up visit

Intervention Reach

Timeframe: Baseline and 6 week follow up visit

Trial details

NCT IDNCT04552587

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-10

Results submitted2022-10-07

View on ClinicalTrials.gov More Head and Neck Cancer trials