This clinical trial evaluates the Survivorship Needs Assessment Planning (SNAP) tool for improving caregiver burden and symptom management among head and neck cancer survivors and their caregivers. Treatment of head and neck cancer includes combinations of surgery, radiation, and chemotherapy that leave survivors with persistent toxicities after treatment and devastating consequences to quality of life. Transitional interventions from treatment to post-treatment are urgently needed to address late and long-term treatment effects, optimize adherence to complex rehabilitation care with multiple specialists, and facilitate coping with life-altering impairments in speech, swallowing, neck/shoulder mobility and appearance. Head and neck cancer caregivers, typically family and/or friends, also face physical, emotional and financial burdens with harmful effects on well-being. As treatment shifts to the home setting, caregivers can experience isolation as they face persistent and new treatment-related toxicities along with complex post-treatment medication regimens and nutritional and speech concerns of survivors. When cancer caregivers feel better prepared, both survivors and caregivers experience more positive outcomes. Unfortunately, most head and neck cancer interventions have focused on active treatment and excluded caregivers, failing to address caregivers’ needs and changing roles in the post-treatment period. The supportive care SNAP tool for head and neck cancer patients and their primary caregivers after treatment may help better prepare them for and cope with post-treatment challenges and promote positive recovery after treatment.
Additional locations may be listed on ClinicalTrials.gov for NCT05811936.
Locations matching your search criteria
United States
South Carolina
Charleston
Medical University of South CarolinaStatus: Active
Contact: Katherine Regan Sterba
Phone: 843-876-2419
PRIMARY OBJECTIVES:
I. To evaluate the effect of SNAP on symptom severity at 9 months post randomization in head and neck cancer survivors in recovery following curative intent radiation therapy with or without surgery and/or concurrent chemotherapy.
II. To evaluate the effect of SNAP on caregiver burden at 9 months post randomization.
SECONDARY OBJECTIVES:
I. To evaluate the effect of SNAP on psychological well-being (anxiety and depression) at 9 months post randomization in head and neck cancer survivor-caregiver dyads.
II. To evaluate the effect of SNAP on healthcare utilization (receipt of recommended care) at 6 months in head and neck cancer survivor-caregiver dyads.
III. To evaluate the effect of SNAP on unmet needs and self-efficacy in head and neck cancer survivor-caregiver at 6 months.
IV. To evaluate the effect of SNAP on communication and patient-centered care in survivors at 6 months.
V. To explore SNAP information-sharing preferences and challenges in survivors, caregivers and providers and characterize optimal implementation strategies for integrating SNAP care plan and application (app) data into clinical workflows guided by the Unified Theory of Acceptance and Use of Technology.
OUTLINE: Participant-caregiver dyads are randomized to 1 of 2 arms.
ARM I (SNAP): Caregivers complete a care-planning visit within 1-2 weeks of the end of patient treatment and then both caregivers and patients complete a care-planning visit at 3 months. Participants receive a personalized care plan based on identified goals with referrals, educational materials, and an action plan on study along with access to a mobile app and twice weekly e-monitoring for 6 weeks.
ARM II (USUAL CARE): Participants receive written caregiver educational materials within 1-2 weeks of the end of patient treatment and written survivorship educational materials at 3-months.
Upon completion of study intervention, participants are followed up at 6 months and 9 months post-randomization.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMedical University of South Carolina
Principal InvestigatorKatherine Regan Sterba
