The SNAP Tool for Head and Neck Cancer Survivor-Caregiver Dyads
NCT05811936
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
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
Conditions5
Locations1 site
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT05811936