Recruiting

Observational Study

Sponsor:

Medical University of South Carolina

Code:

NCT05811936

Conditions

Head and Neck Cancer

Survivorship

Caregiver Burden

Head and Neck Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Survivorship Needs Assessment Planning (SNAP) tool

Study Details

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.

Conditions

Head and Neck Cancer

Survivorship

Caregiver Burden

Head and Neck Neoplasms

Study ID

NCT05811936

Start date

Aug 23, 2023

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

352 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Usual Care

Caregiver- Survivor Dyads in this group will receive routine follow-up care in the HNC clinic. Current standard of care is an Advanced Practice Provider (Physician Assistant or Nurse Practitioner)-delivered survivorship visit after treatment. This visit will take place according to UC in the clinic. UC dyads will also receive printed caregiving and survivorship materials.

experimental: SNAP

Caregiver- Survivor Dyads in this group will receive a two-session intervention spanning 3 months, with a caregiver module within 1-2 weeks of the end of RT and a dyadic module at 3 months. Each session will include a needs- assessment, a tailored care plan with a goal setting discussion, and referrals for unmet needs. Each session follows with a supportive mobile app for 6 weeks.

Interventions

Survivorship Needs Assessment Planning (SNAP) tool

SNAP includes 2 educational survivorship modules for caregivers and survivors. There are 3 main elements: needs assessment, a tailored care plan and a mobile support app. SNAP uses pre-specified categories of needs, resources, and messaging "behind the scenes" to automate the identification, rating and management of high priority needs. Generated tailored care plans include referrals, messages and educational materials mapped to prioritized dyad-reported concerns addressing survivorship domains (diagnosis, treatment, follow-up care). Care plans and referrals are reviewed with an Advanced Practice Provider. Barriers to uptake are addressed, goal-oriented action planning is refined with brief mobile app training. Dyads receive a personalized binder with care plan, referrals, and an action plan. Dyads receive e-monitoring for 6 weeks to check in and identify barriers with algorithm-driven messaging to reinforce progress, provide further resources and encouragement.

Primary outcome measure

  • Change from baseline in Caregiver Burden at 9 months post randomization [ Time Frame: Caregivers will be assessed at baseline, 6 weeks, 6 months, and 9 months post randomization ]
  • Change from baseline in Symptom Severity in head and neck cancer survivors at 9 months post randomization [ Time Frame: Survivors will be assessed at baseline, and at 6 months and 9 months post randomization ]

Central Contacts and Locations

Central contacts

Katherine R Sterba, PhD, MPH

8438762419sterba@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Katherine Sterba, PhD, MPH

8438762419sterba@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • Head and Neck Cancer
  • Survivorship

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-06-11.