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NCT05811936Recruiting

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

Source: ClinicalTrials.gov · Last updated 11 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
352 (estimated)
First submitted
15 Mar 2023
Start date
23 Aug 2023
Primary completion date
31 Dec 2027
Lead sponsor
Medical University of South Carolina
NCT number
NCT05811936

What you commit to

  • Study type: Interventional
  • Planned participants: 352
  • From 23 Aug 2023 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Patient Inclusion Criteria:
  • 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
    • Caregiver Inclusion Criteria:
  • Age \>18
  • Provide care for a loved one with stage I-IV HNC
  • Agrees to participate after being nominated
    • Patient Exclusion Criteria:
  • 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
    • Caregiver Exclusion Criteria:
  • Inability to read or understand English
  • Cognitively impaired and cannot complete interviews, as judged by the referring health care provider

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
Medical University of South Carolina
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CharlestonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.