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

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

Inclusion Criteria7

  • Age \>18
  • Stage I-IV non-metastatic HNC (i.e., lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, larynx and cutaneous cancers)
  • Currently receiving radiation treatment (with/without surgery and/or concurrent chemotherapy) with curative intent
  • Able to nominate caregiver, the primary support person, also interested in participating
  • Age \>18
  • Provide care for a loved one with stage I-IV HNC
  • Agrees to participate after being nominated

Exclusion Criteria11

  • Patients who do not read/understand English
  • Patients who are cognitively impaired and cannot complete interviews as judged by the referring health care provider
  • Patients concurrently diagnosed with and/or receiving treatment for a second "significant" primary cancer, except the following:
  • Excised and cured non-melanoma skin cancer
  • Carcinoma in situ of breast or cervix
  • Superficial bladder cancer
  • Stage 1 differentiated thyroid cancer that is resected or observed
  • pT1a/pT1b prostate cancer comprising \<5% of resected tissue with normal prostate specific antigen (PSA) since resection
  • cT1a/cT1b prostate cancer treated with brachytherapy
  • Inability to read or understand English
  • Cognitively impaired and cannot complete interviews, as judged by the referring health care provider

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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