A Randomized Controlled Trial to Evaluate the Survivorship Needs Assessment Planning (SNAP) Tool for Head and Neck Cancer Survivor-Caregiver Dyads
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- Change from baseline in Caregiver Burden at 9 months post randomization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Study personnel (Coordinator, Nurse, Data Collectors) will not be blinded to group as intervention activities differ by group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria:
- •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:
- •Provide care for a loved one with stage I-IV HNC
- •Agrees to participate after being nominated
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: Survivorship Needs Assessment Planning (SNAP) tool (Behavioral)
结局指标
主要结局
Change from baseline in Caregiver Burden at 9 months post randomization
时间窗: Caregivers will be assessed at baseline, 6 weeks, 6 months, and 9 months post randomization
Caregivers report the extent to which caregiving impacts time, responsibilities, and strain utilizing the Zarit Burden Inventory. Caregivers rate each item on a 5-point Likert scale (0=Never to 4=Always); higher scores (0-16) indicate greater burden. An increase in change from baseline to 6 week, 6 months or 9 months follow up visit would increased caregiver distress; likewise a decrease in change would indicate reduced caregiver distress. Cronbach's alphas in previous research range from 0.81-0.83.
Change from baseline in Symptom Severity in head and neck cancer survivors at 9 months post randomization
时间窗: Survivors will be assessed at baseline, and at 6 months and 9 months post randomization
Symptom burden in survivors will be assessed with the MD Anderson Symptom Inventory-Head and Neck Cancer Module (MDASI-HN) The MDASI -HN includes 13 core items and an additional 9 head and neck cancer module items which calculates a total score of symptom severity. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 Numeric Rating Scale, with 0 being "not present" and 10 being "as bad as you can imagine." Core items and module symptom items are averaged into a mean module severity. A higher score always indicates an increase in severity. A decrease in change from baseline to 9-month assessment indicates improvement of symptoms. Cronbach's alphas in previous research range from 0.88-0.92.
次要结局
- Change from baseline in Depression for Caregivers at 9 months post randomization(Caregivers will be assessed at baseline, 6 months and 9 months)
- Change from baseline in Anxiety for Caregivers at 9 months post randomization(Caregivers will be assessed at baseline, 6 months and 9 months)
- Change from baseline in Depression for Survivors at 9 months post randomization(Survivors will be assessed at baseline, 6 months and 9 months)
- Change from baseline in Anxiety for Survivors at 9 months post randomization(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.(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(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(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(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(Survivors will be assessed at baseline, 6 months, 9 months)
研究者
Katherine Sterba
Professor • COM PHS Administration CC
Medical University of South Carolina