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

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

NCT ID: NCT05811936

Condition: Head and Neck Cancer
Survivorship
Caregiver Burden
Head and Neck Neoplasms

Conditions: Official terms:
Head and Neck Neoplasms
Caregiver Burden

Conditions: Keywords:
Head and Neck Cancer
Survivorship

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Patient and Caregiver dyads will be randomized to either the SNAP intervention group or the Usual Care (UC) group after baseline assessment. Dyads will be randomized to study arm (SNAP or UC) using permuted block randomization with block sizes of 2 or 4. Randomization will be stratified by patient gender (male or female) and treatment (radiation only, radiation + surgery OR chemotherapy, radiation + surgery + chemotherapy).

Primary purpose: Supportive Care

Masking: None (Open Label)

Masking description: Study personnel (Coordinator, Nurse, Data Collectors) will not be blinded to group as intervention activities differ by group.

Intervention:

Intervention type: Behavioral
Intervention name: Survivorship Needs Assessment Planning (SNAP) tool
Description: 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.
Arm group label: SNAP

Other name: SNAP

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.

Detailed 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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Medical University of South Carolina

Address:
City: Charleston
Zip: 29425
Country: United States

Status: Recruiting

Contact:
Last name: Katherine Sterba, PhD, MPH

Phone: 843-876-2419
Email: sterba@musc.edu

Contact backup:
Last name: Katherine Sterba, PhD, MPH

Phone: 8438762419
Email: sterba@musc.edu

Start date: August 23, 2023

Completion date: May 31, 2026

Lead sponsor:
Agency: Medical University of South Carolina
Agency class: Other

Collaborator:
Agency: National Institutes of Health (NIH)
Agency class: NIH

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Medical University of South Carolina

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05811936