Resilience and Equity in Aging, Cancer, and Health (REACH)

Официальное название

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

Обзор

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.

Подробное описание

This research study will be conducted in three phases:

* Phase 1 - Needs assessment and implementation plan * Phase 2 - Pilot Intervention * Phase 3 - Expanded Clinical Trial

* 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.

Вмешательства

• Другое Phase 2 Intervention - Geriatric Co-Management
  Participants will complete an electronic fitness assessment questionnaire - once completed, they will receive a score of "Robust", "Pre-Frail" or "Frail". Those who are "Pre-frail" or "Frail" will be randomized to meet with a study geriatrician for geriatric co-management in addition to usual oncology care. All participants will be followed for a duration of 1 year.

Первичные конечные точки

• Feasibility of electronic fitness assessment questionnaire (developed from Comprehensive Geriatric Assessment tool) [Срок оценки: 1 year]
• Acceptability of electronic fitness assessment questionnaire [Срок оценки: 1 year]
• Association of geriatric consultation with number of unplanned ED visits/hospitalizations among older adult participants [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Dana-Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT04674267 · 20-275

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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