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The SNAP Tool for Head and Neck Cancer Survivor-Caregiver Dyads

NCT05811936 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2025-05-31

No results posted yet for this study

Summary

In this randomized behavioral intervention, head and neck cancer (HNC) survivors and their caregivers (N=176 HNC survivor-caregiver dyads) will be randomized to either Survivorship Needs Assessment Planning (SNAP) or Usual Care (UC) groups to examine the effects of SNAP on outcomes. SNAP includes two sessions with a needs assessment and tailored care plan and a supportive mobile app after completion of radiation to promote uptake of recommended medical and supportive care. The study aims to evaluate the effects of SNAP on symptom severity in patients and caregiver burden in caregivers. Secondary outcomes include psychological distress (anxiety and depression), healthcare utilization (receipt of recommended care) and unmet needs and self-efficacy in HNC survivor-caregiver dyads. Participants will complete surveys at baseline, 6 months, and 9 months post randomization with validated PROMs, and receive intervention modules at the end of radiation and month 3. Participants in the SNAP group will also receive mobile app support.

Conditions

Interventions

BEHAVIORAL

Survivorship Needs Assessment Planning (SNAP) tool

SNAP includes 2 educational survivorship modules for caregivers and survivors. There are 3 main elements: needs assessment, a tailored care plan and a mobile support app. SNAP uses pre-specified categories of needs, resources, and messaging "behind the scenes" to automate the identification, rating and management of high priority needs. Generated tailored care plans include referrals, messages and educational materials mapped to prioritized dyad-reported concerns addressing survivorship domains (diagnosis, treatment, follow-up care). Care plans and referrals are reviewed with an Advanced Practice Provider. Barriers to uptake are addressed, goal-oriented action planning is refined with brief mobile app training. Dyads receive a personalized binder with care plan, referrals, and an action plan. Dyads receive e-monitoring for 6 weeks to check in and identify barriers with algorithm-driven messaging to reinforce progress, provide further resources and encouragement.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Katherine R Sterba, PhD, MPH · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-23
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05811936 on ClinicalTrials.gov