Clinical trial NCT04552587: The HEART Study (Healthy Eating and Recovery Together)
Official title: A Mobile-Support Program to Facilitate Nutritional Caregiving in Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Survivorship
Nutrition Aspect of Cancer
Keywords: mHealth
Head and Neck Cancer
Survivorship
Caregiver
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-09-17
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria
timeFrame: 6 week follow-up visit
measure: Intervention Delivery/ Fidelity
timeFrame: 6 week follow up visit
measure: Intervention Reach
timeFrame: Baseline and 6 week follow up visit
Secondary outcomes:
measure: Ease of Use/System Usability
timeFrame: 6 week follow up visit only (no baseline comparison)
measure: Mean Score of Unmet Needs
timeFrame: Baseline and 6 week follow up visit
measure: PROMIS Depression- Short Form (SF) v1.0 Form 8A
timeFrame: Baseline and 6 week follow-up visit
measure: Mean Score of Survivorship Readiness/Caregiver Preparedness
timeFrame: Baseline and 6 week follow-up visit
measure: Mean Score of Self-Efficacy
timeFrame: Baseline and 6 week follow-up visit
measure: Mean Score of Dyadic Coping/ Dyadic Efficacy
timeFrame: Baseline and 6 week follow-up visit
measure: Health-Related Quality-of-Life (PROMIS Scale v1.2 - Global Health)
timeFrame: Baseline and 6 week follow-up visit
measure: Caregiver Burden
timeFrame: Baseline and 6 week follow up visit
measure: Ease of Mobile App Use/User Engagement
timeFrame: 4 weeks during app use
measure: Number of Participants With Care Plan Use Endpoints
timeFrame: 6 week follow up visit
measure: Percentage of Participants Rating App Satisfaction/ Perceived Importance
timeFrame: 6 week follow up visit
measure: Process Monitoring Data
timeFrame: After session completion
measure: Change From Baseline in Nutritional Status Scale
timeFrame: Baseline and 6 week follow up visit
measure: Change From Baseline in Symptom Distress/Symptom Management
timeFrame: Baseline and 6 week follow up visit
measure: Change From Baseline in Emotional Support
timeFrame: Baseline and 6 week follow up visit
measure: Change From Baseline in Symptom Severity
timeFrame: Baseline and 6 week follow up visit
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of SC
name: Katherine Sterba, PhD. MPH
role: PRINCIPAL_INVESTIGATOR
References: