The HEART Study (Healthy Eating and Recovery Together)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- Acceptability [6 week follow-up]
satisfaction ratings of session, care plan and App
- Fidelity (delivery of the intervention as planned) [Through study completion, an average of 8 weeks]
Percentage of protocol steps completed
Secondary Outcome Measures
- Unmet Needs [Baseline and 6 week follow-up]
30-item Cancer Survivors/Partners Unmet Needs instruments
- Depression [Baseline and 6 week follow-up]
8-item Patient-Reported Outcomes Measure Information System (PROMIS) short-form instrument
- Survivorship Knowledge [Baseline and 6 week follow-up]
11-item Preparing for Life As a New Survivor (PLANS) measure developed at the University of Michigan
- Satisfaction with provider communication [Baseline and 6 week follow-up]
8-item scale from the National Cancer Institute Follow-up Care Use Among Survivors (FOCUS) survey to assess
- Dyadic Coping [Baseline and 6 week follow-up]
cancer-specific version of the 5-item dyadic coping subscale of the Dyadic Coping Inventory
- Health-related Quality-of-Life [Baseline and 6 week follow-up]
10-item Patient-Reported Outcomes Measure Information System (PROMIS) global quality of life instrument
- Caregiver Burden [Baseline and 6 week follow-up]
4-item screening version of the Zarit Burden Interview
- Mobile app use [Four weeks during app use]
Percentage of prompt responses completed
Eligibility Criteria
Criteria
Patient Inclusion Criteria:
-
18 years and older
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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)
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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
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Experienced nutritional challenges at the end of treatment as assessed in a 6-item screener
Patient Exclusion Criteria:
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head and neck cancer patients who do not undergo treatment
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Patients who do not read or understand English
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Patients who are cognitively impaired and cannot complete interviews, as judged by the referring health care provider
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Patients who do not have a smartphone for use in the study
Caregiver Inclusion Criteria:
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18 years and older
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
Sponsors and Collaborators
- Medical University of South Carolina
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Katherine Sterba, PhD. MPH, Medical University of SC
Study Documents (Full-Text)
More Information
Publications
None provided.- 0006621
- R21CA215557-02