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NCT05811936 | RECRUITING | Head and Neck Cancer

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

Medical University of South Carolina

Information provided by (Responsible Party):

Katherine Sterba

Brief 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.

Condition or disease

Head and Neck Cancer

Survivorship

Caregiver Burden

Head and Neck Neoplasms

Intervention/treatment

Survivorship Needs Assessment Planning (SNAP) tool

Phase

NA

Detailed Description:

The SNAP Intervention includes two care planning modules, a caregiver visit (module I) during the end of radiation treatment and a dyad-focused (survivor and caregiver) visit (module II) at 3 months. Each SNAP module includes 3 components including: 1) an in-clinic needs assessment, 2) a tailored care plan and 3) text-based e-monitoring at home. In both modules, a care plan is generated with algorithm-triggered messages and referrals to recommended care matched to endorsed concerns. Care plans are reviewed and barriers are addressed. Referrals are finalized with an Advanced Practice Provider (APP). SNAP Participants leave with a personalized binder including the survivorship care plan and referrals. SNAP Participants use an e-monitoring App and receive twice weekly engagement prompts for 6 weeks. Usual Care (UC) participants will receive caregiver education and dyadic survivorship education visit at the end of radiation treatment and 3-months post-randomization, respectively, with printed materials from the National Cancer Institute.

Study Type : INTERVENTIONAL
Estimated Enrollment : 352 participants
Masking : NONE
Masking Description : Study personnel (Coordinator, Nurse, Data Collectors) will not be blinded to group as intervention activities differ by group.
Primary Purpose : SUPPORTIVE_CARE
Official Title : A Randomized Controlled Trial to Evaluate the Survivorship Needs Assessment Planning (SNAP) Tool for Head and Neck Cancer Survivor-Caregiver Dyads
Actual Study Start Date : 2023-08-23
Estimated Primary Completion Date : 2026-05-31
Estimated Study Completion Date : 2026-05-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Patient Inclusion Criteria
  • 1. Age \>18
  • 2. Stage I-IV non-metastatic HNC (i.e., lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, larynx and cutaneous cancers)
  • 3. Currently receiving radiation treatment (with/without surgery and/or concurrent chemotherapy) with curative intent
  • 4. Able to nominate caregiver, the primary support person, also interested in participating
  • Caregiver Inclusion Criteria
    • 1. Age \>18
    • 2. Provide care for a loved one with stage I-IV HNC
    • 3. Agrees to participate after being nominated
    • Patient Exclusion Criteria
      • 1. Patients who do not read/understand English
      • 2. Patients who are cognitively impaired and cannot complete interviews as judged by the referring health care provider
      • 3. 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
        • Caregiver Exclusion Criteria
          • 1. Inability to read or understand English
          • 2. Cognitively impaired and cannot complete interviews, as judged by the referring health care provider
The SNAP Tool for Head and Neck Cancer Survivor-Caregiver Dyads

Location Details

NCT05811936

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Locations

RECRUITING

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425