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

Официальное название

A Randomized Controlled Trial to Evaluate the Survivorship Needs Assessment Planning (SNAP) Tool for Head and Neck Cancer Survivor-Caregiver Dyads

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Change from baseline in Caregiver Burden at 9 months post randomization [Срок оценки: 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 [Срок оценки: Survivors will be assessed at baseline, and at 6 months and 9 months post randomization]

Вторичные конечные точки (9)

• Change from baseline in Depression for Caregivers at 9 months post randomization [Срок оценки: Caregivers will be assessed at baseline, 6 months and 9 months]
• Change from baseline in Anxiety for Caregivers at 9 months post randomization [Срок оценки: Caregivers will be assessed at baseline, 6 months and 9 months]
• Change from baseline in Depression for Survivors at 9 months post randomization [Срок оценки: Survivors will be assessed at baseline, 6 months and 9 months]
• Change from baseline in Anxiety for Survivors at 9 months post randomization [Срок оценки: Survivors will be assessed at baseline, 6 months and 9 months]
• Change in Healthcare Utilization (HCU)/ receipt of recommended care at 6 months in head and neck cancer survivor-caregiver dyads. [Срок оценки: Dyads (Survivor & Caregiver) will be assessed at baseline, 6 months and 9 months]
• Change in from baseline Unmet Needs at 6 months in head and neck cancer Caregivers [Срок оценки: Caregivers will be assessed at baseline, 6 weeks, 6 months, 9 months]
• Change in from baseline Unmet Needs at 6 months in head and neck cancer Survivors [Срок оценки: Survivors will be assessed at baseline, 6 months, 9 months]
• Change in from baseline Self-efficacy at 6 months in head and neck cancer Caregivers [Срок оценки: Caregivers will be assessed at baseline, 6 weeks, 6 months, 9 months]
• Change in from baseline Self-efficacy at 6 months in head and neck cancer Survivors [Срок оценки: Survivors will be assessed at baseline, 6 months, 9 months]

Критерии участия

Patient Inclusion Criteria:

• Age >18
• Stage I-IV non-metastatic HNC (i.e., lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, larynx and cutaneous cancers)
• Currently receiving radiation treatment (with/without surgery and/or concurrent chemotherapy) with curative intent
• Able to nominate caregiver, the primary support person, also interested in participating

Caregiver Inclusion Criteria:

• Age >18
• Provide care for a loved one with stage I-IV HNC
• Agrees to participate after being nominated

Patient Exclusion Criteria:

• Patients who do not read/understand English
• Patients who are cognitively impaired and cannot complete interviews as judged by the referring health care provider
• 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:

• Inability to read or understand English
• Cognitively impaired and cannot complete interviews, as judged by the referring health care provider

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT05811936 · 00114288 · R01CA259186-01 · R01CA259186-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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