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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT05811936
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Survivorship Needs Assessment Planning (SNAP) tool — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 23, 2023
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
352 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Usual Care
    Caregiver- Survivor Dyads in this group will receive routine follow-up care in the HNC clinic. Current standard of care is an Advanced Practice Provider (Physician Assistant or Nurse Practitioner)-delivered survivorship visit after treatment. This visit will take place according to UC in the clinic. UC dyads will also receive printed caregiving and survivorship materials.
  • Experimental: SNAP
    Caregiver- Survivor Dyads in this group will receive a two-session intervention spanning 3 months, with a caregiver module within 1-2 weeks of the end of RT and a dyadic module at 3 months. Each session will include a needs- assessment, a tailored care plan with a goal setting discussion, and referrals for unmet needs. Each session follows with a supportive mobile app for 6 weeks.

Primary Outcome Measure

Change from baseline in Caregiver Burden at 9 months post randomization [ Time Frame: Caregivers will be assessed at baseline, 6 weeks, 6 months, and 9 months post randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Katherine Sterba, PhD, MPH
[email protected]
8438762419

Find similar trials in Charleston, SC

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Medical University of South Carolina· Charleston, SC

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