Clinical trial · Interventional
The HEART Study (Healthy Eating and Recovery Together)
A Mobile-Support Program to Facilitate Nutritional Caregiving in Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Nutrition Aspect of Cancer | Head and Neck Neoplasm | PROBABILISTIC | 0.70 |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Heart APP | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HEART
- description
- 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.
- interventionNames
- Behavioral: Heart APP
Primary outcomes (3)
- measure
- Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria
- timeFrame
- 6 week follow-up visit
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available