NCT05811936 The SNAP Tool for Head and Neck Cancer Survivor-Caregiver Dyads
| NCT ID | NCT05811936 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 352 participants |
| Start Date | 2023-08-23 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 352 participants in total. It began in 2023-08-23 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Katherine R Sterba, PhD, MPH
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT05811936 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05811936 currently recruiting?
Yes, NCT05811936 is actively recruiting participants. Contact the research team at sterba@musc.edu for enrollment information.
Where is the NCT05811936 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT05811936 clinical trial?
NCT05811936 is sponsored by Medical University of South Carolina. The principal investigator is Katherine R Sterba, PhD, MPH at Medical University of South Carolina. The trial plans to enroll 352 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.