A program to support head and neck cancer survivors and their caregivers
A Randomized Controlled Trial to Evaluate the Survivorship Needs Assessment Planning (SNAP) Tool for Head and Neck Cancer Survivor-Caregiver Dyads
This study is testing a new support program for head and neck cancer survivors and their caregivers to see if it helps them manage symptoms and reduces stress compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 352 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05811936 on ClinicalTrials.gov |
What this trial studies
This intervention involves head and neck cancer survivors and their caregivers participating in a randomized trial to assess the effectiveness of the Survivorship Needs Assessment Planning (SNAP) tool compared to usual care. The SNAP tool includes two sessions that provide a needs assessment, tailored care plan, and a supportive mobile app to enhance care after radiation treatment. The study aims to evaluate the impact of SNAP on symptom severity for patients and caregiver burden, as well as secondary outcomes like psychological distress and healthcare utilization. Participants will complete surveys at baseline, 6 months, and 9 months post-randomization to measure various health outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with stage I-IV non-metastatic head and neck cancer currently undergoing radiation treatment, along with a nominated caregiver.
Not a fit: Patients who are cognitively impaired or do not understand English may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life for head and neck cancer survivors and reduce the burden on their caregivers.
How similar studies have performed: Other studies have shown promise in using tailored interventions for cancer survivorship, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Katherine R Sterba, PhD, MPH — Medical University of South Carolina
- Study coordinator: Katherine R Sterba, PhD, MPH
- Email: sterba@musc.edu
- Phone: 8438762419
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.