Resilience and Equity in Aging, Cancer, and Health (REACH): Promoting Physical Resilience and Cancer Care Equity for Adults Age 70 and Older Diagnosed With Gastrointestinal Malignancy
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- Feasibility of electronic fitness assessment questionnaire (developed from Comprehensive Geriatric Assessment tool)
概览
简要总结
The purpose of this multi-phase research study is to understand how consultation of cancer care with a geriatrician can best improve outcomes for older adults with gastrointestinal malignancies.
详细描述
This research study will be conducted in three phases:
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Phase 1 - Needs assessment and implementation plan
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Phase 2 - Pilot Intervention
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Phase 3 - Expanded Clinical Trial
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Please note Phase 2 - Pilot Intervention and Phase 3 - Expanded Clinical Trial will be added to the clinicaltrials.gov record once Institutional Review Board (IRB) approved.
Phase 1 is composed of three aims and will inform the subsequent two phases:.
- Aim 1: To evaluate the perceived needs of Older Adults diagnosed with gastrointestinal malignancies, caregivers, staff, and faculty to characterize the implementation setting for a geriatric consultation.
- Aim 2: To refine the proposed REACH program implementation plan based on qualitative feedback provided by Older Adult (OA) patients, their identified caregivers, staff, and faculty.
- Aim 3: Determine the patient, demographic, social determinants, clinical and disease characteristics of Older Adults (OA) associated with ED visits/hospitalization following initial oncology consultation at DF/BWCC in year 2019.
- Phase 2 intervention has started as of January 2022 following IRB approval. Study team has begun recruiting participants into Phase 2 intervention of REACH study starting in January 2022. Participants approached by REACH coordinator for consenting and enrollment after their initial consult visit at Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC). Participants are then asked to complete an electronic fitness assessment (EFA) that is sent to them via Patient Gateway. Participants complete this questionnaire and receive a score of "Robust", "Pre-frail", or "Frail" - those who score "Pre-frail" or "Frail" will be randomized to meet with a study geriatrician for geriatric co-management intervention alongside their standard oncology care. All enrolled participants will be followed for a duration of 1 year as they are continuing care at DF/BWCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are age 70+ at time of initial consult at DF/BWCC
- •Diagnosed with a gastrointestinal cancer, including: cancers of the esophagus, stomach, pancreas, liver, bile duct, ampulla, colon, rectum, or anus, as well as neuroendocrine tumors.
- •Continuing care at DF/BWCC beyond initial consult visit
- •English and Spanish-speaking
排除标准
- •Patients less than age 70 at time of initial consultation appointment with DF/BWCC.
- •Patients who are not continuing care at DF/BWCC beyond first consult visit.
- •Not proficient in English or Spanish
- •Patient who are not considered appropriate for enrollment due to complex medical, social, or other situation as determined by their primary oncology team.
- •Participants with psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Intervention Phase - Geriatric Co-Management
Eligible older adults age 70 and older who score "Pre-Frail" or "Frail" will be randomized 2:1 to be offered to meet with a study geriatrician for geriatric co-management in addition to their standard oncology care. Study geriatrician will assist with management of symptoms, additional comorbidities, polypharmacy, and social/emotional concerns in addition to physical care. Geriatrician can make referrals and recommendations for additional supportive services that may be beneficial for more vulnerable older adult patients.
干预措施: Phase 2 Intervention - Geriatric Co-Management (Other)
Intervention Phase - Standard Oncology Care
This arm is for those older adult patients (age 70+) who score as "Pre-Frail" or "Frail" in the fitness assessment questionnaire and are NOT randomized to meet with the study geriatrician. These patients will be followed for the duration of the study as they proceed with their usual oncology care. Study team will evaluate a number of different measures and outcomes, the primary one being unplanned emergency and hospital visits during the course of the study.
结局指标
主要结局
Feasibility of electronic fitness assessment questionnaire (developed from Comprehensive Geriatric Assessment tool)
时间窗: 1 year
EFA questionnaire deployed to older adult patients age 70+ in the REACH study. Feasibility will be determined by the proportion of participants who consent to complete the electronic fitness assessment. The intervention will be considered feasible if 70% of participants consent to complete the fitness assessment.
Acceptability of electronic fitness assessment questionnaire
时间窗: 1 year
Acceptability of electronic fitness assessment questionnaire via the Patient Portal or internet-enabled device following second clinic visit among older adults diagnosed with gastrointestinal cancer seeking consultation at DF/BWCC for medical, radiation, or surgical oncology. Acceptability will be determined by the proportion of participants who fully complete the EFA. The intervention will be considered acceptable if 60% of enrolled participants fully complete the EFA within 14 days of enrollment.
Association of geriatric consultation with number of unplanned ED visits/hospitalizations among older adult participants
时间窗: 1 year
Association of geriatrician consult with number of ED visits/hospitalizations among older adults diagnosed with gastrointestinal cancer randomized to the geriatric consultation intervention. Randomization will be essential to evaluate the efficacy of geriatric consultation intervention in impacting unplanned ED visits and hospitalizations.
次要结局
未报告次要终点
研究者
Nadine Jackson, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute