Implementation and Effectiveness Trial of HN-STAR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 357
- 试验地点
- 85
- 主要终点
- Change in HNC-Specific QOL
研究概览
简要总结
People who have been treated for head and neck cancer (HNC survivors) can experience serious consequences from their cancer and its treatment, ongoing risks of new cancers, and other unrelated illnesses. These concerns pose challenges to the provision of comprehensive care to HNC survivors. We created HN-STAR to facilitate and tailor the ongoing care of HNC survivors. Survivors use HN-STAR on a computer or tablet to answer questions about symptoms and health concerns before a routine visit with a cancer care provider. During the clinic visit, the provider uses HN-STAR to see evidence-based recommendations for managing each concern reported by the survivor. The provider and survivor discuss recommendations and select appropriate actions (e.g., testing, referrals, prescriptions, self-management). HN-STAR produces a survivorship care plan that includes all reported concerns and the actions selected in clinic. The survivorship care plan is given to the survivor and the primary care provider. Three months, six months, and nine months later, the survivor uses HN-STAR from home (or clinic) to report their concerns again, and a new survivorship care plan is created each time.
Our trial randomizes 20-36 oncology practices from the National Community Oncology Research Program to use HN-STAR or provide usual care to 298-400 recent survivors of head and neck cancer. We hypothesize that survivors in the HN-STAR arm will have greater improvement in patient-centered outcomes (including cancer-related well-being, symptoms, and patient activation) over one year compared to survivors in the usual care arm, measured by surveys at baseline and one year later. We also hypothesize that survivors in the HN-STAR arm will be more likely to receive care that is aligned with evidence-based recommendations during the year of the study than survivors in the usual care arm. Our final aim investigates the implementation of HN-STAR in clinical practice, using interviews and surveys of survivors, providers, and other clinic staff to understand the feasibility, acceptability, appropriateness, and other aspects of providing survivorship care to head and neck cancer survivors.
详细描述
In this cluster randomized hybrid implementation-effectiveness controlled trial, 10-18 intervention practices will provide care with access to HN-STAR, and 10-18 practices will provide usual care without access to HN-STAR. We will implement no more than five intervention sites within the first 3 months of activation. Providers at each site will be invited to view a video regarding head and neck survivorship care. Designated providers at each intervention site will be trained to use HN-STAR during routine follow-up care with survivors. Eligible survivors who completed treatment for head and neck cancer ≤24 months ago with no evidence of disease (N=298-400) will complete a Survivor Baseline Health Assessment prior to visiting an oncology provider, a brief Survivor Post-Visit Survey about their clinic visit, and a Survivor Follow-Up Health Assessment one year later. Survivors in the intervention arm will additionally complete Survivor Quarterly Health Assessments every three months after the clinic visit, which will produce an updated SCP. We will compare changes in patient-centered outcomes from baseline to 1-year in survivors at the intervention and usual care clinics using data from health assessments. The primary patient-centered outcome is head and neck cancer-specific quality of life measured at baseline and follow-up. Other patient-centered outcomes include symptom burden, patient activation, and perceived quality of care, also measured at baseline and follow-up. The secondary outcome of receipt of guideline-concordant care will be assessed using data from the Survivor and Designated Clinician Post-Visit Surveys and the Primary Care Provider (PCP) and Oncology Medical Records Abstraction forms from oncology practices and primary care providers identified by enrolled survivors. NCORP staff at each practice will request outside records (with survivor permission via a signed local Medical Release Form) and abstract data from these medical records. Implementation data will come from Survivor Post-Visit Survey and Survivor Follow-up Health Assessment, interviews at two time points with a subset of survivors (Survivor Post-Visit and Follow-Up Interviews, N=40), interviews with a subset of primary care providers a year after the designated clinic visit (Primary Care Provider Interview, N=30-40), surveys of stakeholders and designated clinicians at two time points (Stakeholder and Designated Clinician Initial and Final Surveys), and interviews of stakeholders and designated clinicians at one time point (Stakeholder and Designated Clinician Final Interview). All interviews will be conducted by Memorial Sloan Kettering study team members.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Survivor Inclusion Criteria:
- •Age ≥18 years.
- •Diagnosis of primary or locoregionally recurrent head and neck squamous cell carcinoma, specifically oral cavity, larynx, oropharynx, hypopharynx, and unknown squamous cell carcinoma primary.
- •Completed chemotherapy and/or radiation therapy with curative intent for head and neck squamous cell carcinoma ≤ 24 months prior to designated clinician visit.
- •Deemed free of disease at last assessment.
- •Cognitively and physically able to complete study survey per local NCORP site staff discretion.
- •Scheduled for a clinic visit with a provider who has agreed to participate in this study and meets requirements for the arm to which their practice has been assigned (the practice designated clinician) for routine follow-up.
- •Willing to complete study assessments 3, 6, and 9 months after the designated clinic visit either 1) remotely (via telephone or videoconference using smartphone, tablet, or computer) or 2) at the clinic to complete study assessments on a clinic tablet or computer.
排除标准
- •In active cancer treatment (including hormone therapy) for any other cancer, excluding local therapy for non-melanoma skin cancer.
- •Evidence of prior cancer (excluding non-melanoma skin cancer) within 3 years of the designated clinician visit.
- •Head and neck tumor histology of lymphoma, adenocarcinoma or melanoma.
- •Recurrent, persistent, or progressive disease at last assessment (per scan or clinical assessment).
- •Does not speak or read English, because the HN-STAR tool is only available in English at this time.
- •Received only surgery as treatment for head and neck cancer.
- •Current, planned enrollment, or in follow-up on another interventional symptom management study protocol, as per patient self-report or research staff members' knowledge at the time of consent. Concurrent participation in treatment or imaging studies is allowed.
- •Designated Clinician Inclusion Criteria:
- •Age > = 18 years
- •MD, DO, NP, or PA
- •Able to speak and read English, because the HN-STAR tool is only available in English at this time.
- •Routinely provides care for cancer patients or survivors.
- •Willing to complete study-specific trainings and incorporate HN-STAR or provide usual care in a routine follow-up care visit
- •Stakeholders Inclusion Criteria:
- •Age > = 18
- •Member of the practice clinical or administrative team who is involved in the oversight of the delivery of head and neck cancer survivorship care or who would make decisions about implementing head and neck survivorship tools such as HN-STAR. This could include clinic administrators, nurse navigators, key clinical team members, program directors, and other staff (e.g., service line or nursing leaders).
- •Employed for at least one month at the practice.
- •Able to speak and reads English, because the HN-STAR tool is only available in English at this time.
- •Stakeholder Exclusion Criteria:
- •Is the designated clinician at the practice.
- •Primary Care Provider Inclusion Criteria:
- •Provides primary care (general preventative care) to a survivor enrolled in the HN-STAR study.
- •Age >= 18
- •MD, DO, NP, or PA
- •Primary Care Provider Exclusion Criteria:
- •Provides Oncology Care
研究组 & 干预措施
HN-STAR
a web-based intervention to improve the quality of care for HNC survivors, which incorporates an automatically generated SCP as one component of guideline-based survivorship care.
干预措施: HN-STAR Intervention (Other)
Usual Care
No intervention
结局指标
主要结局
Change in HNC-Specific QOL
时间窗: Baseline & 1 year
Measured using Trial Outcome Index from the Functional Assessment of Cancer Therapy Head and Neck. It is a 23-item summary measure that ranges from 0 to a maximum of 96 where higher scores indicate better overall physical and functional outcomes.
次要结局
- Change in symptom burden(Baseline & 1 year)
- Change in patient activation(Baseline & 1 year)
- Change symptom burden(Baseline & 1 year)
- Change in pain(Baseline & 1 year)
- Change in perceived quality of cancer care(Baseline & 1 year)
- Adherence and surveillance of guideline concordant care(These variables will be derived from the medical record during the year following the initial visit.)
- Change in QoL(Baseline & 1 year)