N/A
N=50
The HEART Study (Healthy Eating and Recovery Together)
Head and Neck Cancer · Survivorship · Nutrition Aspect of Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04552587 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria — 18; 18; 17; 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heart APP (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria |
18; 18; 17; 15; 18; 18 | — |
| PRIMARY Intervention Delivery/ Fidelity |
19 | — |
| PRIMARY Intervention Reach |
46 | — |
| SECONDARY Ease of Use/System Usability |
76 | — |
| SECONDARY Mean Score of Unmet Needs |
9.5; 8.6; 8.9; 7.5; -0.6; -1.0 | — |
| SECONDARY PROMIS Depression- Short Form (SF) v1.0 Form 8A |
51.2; 51.1; 48.0; 49.6; -3.2; -1.5 | — |
| SECONDARY Mean Score of Survivorship Readiness/Caregiver Preparedness |
4.5; 4.6; 4.6; 4.5; 0.1; -0.1 | — |
| SECONDARY Mean Score of Self-Efficacy |
3.3; 3.0; 3.2; 2.8; -0.1; -0.2 | — |
| SECONDARY Mean Score of Dyadic Coping/ Dyadic Efficacy |
4.3; 4.1; 4.2; 4.1; -0.2; 0.0 | — |
| SECONDARY Health-Related Quality-of-Life (PROMIS Scale v1.2 - Global Health) |
47.7; 49.0; 42.4; 50.4; 46.6; 48.5 | — |
| SECONDARY Caregiver Burden |
1.8; 1.9; 0.1 | 0.23 |
| SECONDARY Ease of Mobile App Use/User Engagement |
70 | — |
| SECONDARY Number of Participants With Care Plan Use Endpoints |
17; 20; 10; 8; 10; 16 | — |
| SECONDARY Percentage of Participants Rating App Satisfaction/ Perceived Importance |
17; 13; 15; 11; 10; 12 | — |
| SECONDARY Process Monitoring Data |
51; 13; 12 | — |
| SECONDARY Change From Baseline in Nutritional Status Scale |
3.5; 3.3; 3.0; 2.5; -0.5; -0.8 | — |
| SECONDARY Change From Baseline in Symptom Distress/Symptom Management |
4.6; 5.6; 4.2; 4.3; -0.4; -1.3 | — |
| SECONDARY Change From Baseline in Emotional Support |
56.0; 52.0; 55.7; 52.8; -0.3; 0.8 | — |
| SECONDARY Change From Baseline in Symptom Severity |
3.0; 2.0; -1.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04552587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.