RecruitingNot ApplicableNCT05811936

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

A Randomized Controlled Trial to Evaluate the Survivorship Needs Assessment Planning (SNAP) Tool for Head and Neck Cancer Survivor-Caregiver Dyads

Sponsor

Medical University of South Carolina

Enrollment

352 participants

Start Date

Aug 23, 2023

Study Type

INTERVENTIONAL

Conditions

Head and Neck Cancer Survivorship Head and Neck Neoplasms Caregiver Burden

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a digital tool called the SNAP Tool to help head and neck cancer patients and their caregivers communicate better about needs, side effects, and support during radiation treatment. **You may be eligible if (patient)...** - You are over 18 with stage I–IV non-metastatic head and neck cancer (throat, mouth, voice box, or nearby structures) - You are currently receiving radiation treatment aimed at curing your cancer - You can name a caregiver who is willing to also participate **You may be eligible if (caregiver)...** - You are over 18 and care for a loved one with stage I–IV head and neck cancer - Your loved one is currently in radiation treatment **You may NOT be eligible if...** - Your cancer has spread to distant organs - You do not have a caregiver willing to participate (patient) - You are under 18 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSurvivorship 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.

Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT05811936

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