Clinical trial NCT05811936: The SNAP Tool for Head and Neck Cancer Survivor-Caregiver Dyads
Official title: A Randomized Controlled Trial to Evaluate the Survivorship Needs Assessment Planning (SNAP) Tool for Head and Neck Cancer Survivor-Caregiver Dyads
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Survivorship
Caregiver Burden
Head and Neck Neoplasms
Keywords: Head and Neck Cancer
Survivorship
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2023-04-13
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

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

Primary outcomes:
measure: Change from baseline in Caregiver Burden at 9 months post randomization
timeFrame: Caregivers will be assessed at baseline, 6 weeks, 6 months, and 9 months post randomization
measure: Change from baseline in Symptom Severity in head and neck cancer survivors at 9 months post randomization
timeFrame: Survivors will be assessed at baseline, and at 6 months and 9 months post randomization
Secondary outcomes:
measure: Change from baseline in Depression for Caregivers at 9 months post randomization
timeFrame: Caregivers will be assessed at baseline, 6 months and 9 months
measure: Change from baseline in Anxiety for Caregivers at 9 months post randomization
timeFrame: Caregivers will be assessed at baseline, 6 months and 9 months
measure: Change from baseline in Depression for Survivors at 9 months post randomization
timeFrame: Survivors will be assessed at baseline, 6 months and 9 months
measure: Change from baseline in Anxiety for Survivors at 9 months post randomization
timeFrame: Survivors will be assessed at baseline, 6 months and 9 months
measure: Change in Healthcare Utilization (HCU)/ receipt of recommended care at 6 months in head and neck cancer survivor-caregiver dyads.
timeFrame: Dyads (Survivor & Caregiver) will be assessed at baseline, 6 months and 9 months
measure: Change in from baseline Unmet Needs at 6 months in head and neck cancer Caregivers
timeFrame: Caregivers will be assessed at baseline, 6 weeks, 6 months, 9 months
measure: Change in from baseline Unmet Needs at 6 months in head and neck cancer Survivors
timeFrame: Survivors will be assessed at baseline, 6 months, 9 months
measure: Change in from baseline Self-efficacy at 6 months in head and neck cancer Caregivers
timeFrame: Caregivers will be assessed at baseline, 6 weeks, 6 months, 9 months
measure: Change in from baseline Self-efficacy at 6 months in head and neck cancer Survivors
timeFrame: Survivors will be assessed at baseline, 6 months, 9 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Katherine R Sterba, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: