The SNAP Tool for Head and Neck Cancer Survivor-Caregiver Dyads

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Caregiver Burden; Survivorship; Head and Neck Neoplasms; Head and Neck Cancer

Treatments: Behavioral: Survivorship Needs Assessment Planning (SNAP) tool

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05811936

R01CA259186-02 (U.S. NIH Grant/Contract)

R01CA259186-01 (U.S. NIH Grant/Contract)

00114288

Details and patient eligibility

About

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.

Full description

The SNAP Intervention includes two care planning modules, a caregiver visit (module I) during the end of radiation treatment and a dyad-focused (survivor and caregiver) visit (module II) at 3 months. Each SNAP module includes 3 components including: 1) an in-clinic needs assessment, 2) a tailored care plan and 3) text-based e-monitoring at home. In both modules, a care plan is generated with algorithm-triggered messages and referrals to recommended care matched to endorsed concerns. Care plans are reviewed and barriers are addressed. Referrals are finalized with an Advanced Practice Provider (APP). SNAP Participants leave with a personalized binder including the survivorship care plan and referrals. SNAP Participants use an e-monitoring App and receive twice weekly engagement prompts for 6 weeks. Usual Care (UC) participants will receive caregiver education and dyadic survivorship education visit at the end of radiation treatment and 3-months post-randomization, respectively, with printed materials from the National Cancer Institute.

Enrollment: 352 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

352 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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.

SNAP

Experimental group

Description:

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.

Treatment:

Behavioral: Survivorship Needs Assessment Planning (SNAP) tool