This trial studies how well a mobile-support program works in improving nutrition management in participants with stage I-IVB head and neck cancer and their caregivers. A tool for use in the clinic to assess the nutritional support needs of head and neck cancer patients and their primary caregivers after treatment may help to prepare a care plan and mobile support system to help patients and caregivers prepare for and cope with nutritional challenges after treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04552587.
PRIMARY OBJECTIVES:
I. To develop and pretest a mobile nutritional support system (needs assessment tool, care plan template and mobile messaging program) for head and neck cancer (HNC) survivor-caregiver dyads at the end of treatment.
Ia. Identify high-priority caregiver nutritional need domains using key informant interviews with survivors and caregivers and surveys with a national panel of oncology dietitians.
Ib. Translate key oncology nutritional rehabilitation recommendations into caregiver-focused support steps and match care plan resources and mobile support messages for each identified need.
Ic. Develop and pretest the needs assessment technology, care plan template and mobile support message delivery system with HNC survivors, caregivers and health care providers.
II. To pilot-test the implementation of the mobile support system in 33 HNC dyads (N=66).
IIa. Examine the acceptability of using the mobile support system to assess dyads’ nutritional needs, generate personalized care plans and deliver caregiver mobile support.
IIb. Examine the feasibility of the mSupport system by evaluating intervention delivery factors (i.e., ease of use, engagement, satisfaction, barriers, unmet needs, preferred data collection modes), resource needs (i.e., staff, time, equipment, extension to community), and study methods (i.e., timing, recruitment, process/outcome measures).
IIc. Synthesize findings and refine the mobile support system in preparation for large-scale evaluation.
OUTLINE:
PHASE I: Participants attend 15 interviews over 30-45 minutes and complete surveys to help develop a mobile-support program for NHC survivors and their caregivers.
PHASE II: Participants attend an in-person clinic session over 45-60 minutes. Participants are prompted twice a week for 4 weeks to report symptoms, nutritional status and distress with algorithm-driven links to 3 support sources, including messages, tips and peer videos. Nurse practitioners also attend in-depth interviews.
After completion of study, participants are followed up at 6 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMedical University of South Carolina
Principal InvestigatorKatherine Regan Sterba
