Promoting Physical Resilience and Cancer Care Equity for Older Adults Diagnosed with Gastrointestinal Malignancy, REACH Study
This clinical trial studies if electronic assessment of fitness alone or in combination with consultation with a geriatrician can improve health outcomes for older adults with gastrointestinal malignancies. A geriatrician is a doctor who is specially trained to care for older adults. Information from this study may help researchers better understand how to promote physical resilience in older adults with gastrointestinal malignancies.
Inclusion Criteria
- PHASE I: Gastrointestinal Cancer Center (GCC) English-speaking OA age >= 70 and identified caregivers of older adult patients
- PHASE I: Clinical staff and faculty included social workers, physicians, nurse practitioners, physician assistants, oncology nurse navigators, infusion nurses, clinical specialists and nurse educators
- PHASE II PATIENTS: Age >= 65 years and diagnosed with a gastrointestinal cancer, including any of the following: cancers of the esophagus, stomach, pancreas, liver, bile duct, ampulla, colon, rectum, or anus, as well as neuroendocrine tumors are eligible for this study
- PHASE II PATIENTS: Participants must be continuing care at DF/BWCC in order to be eligible for REACH (including Longwood and Chestnut Hill locations)
- PHASE II PATIENTS: Patients who screen pre-frail or frail from the electronic frailty assessment (EFA) (scores of 0.2 – 0.34 or 0.35 – 1, respectively) are eligible for the research study which includes geriatric and pharmacy consult
- PHASE II PATIENTS: For patients scheduled in the Pancreas and Biliary Tumor Center (PBTC), they will be eligible for research approach regardless of EFA frailty score (robust, pre-frail, or frail). At this time, patients must be proficient in English, Spanish, Portuguese, Russian, Arabic, Traditional Chinese, or Haitian Creole to participate
- PHASE II PATIENTS: Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
- PHASE II PATIENTS: Patients who are < 65 years old at time of consultation appointment with DF/BWCC
- PHASE II PATIENTS: Patients who do not continue care at DF/BWCC beyond a first consult visit
- PHASE II PATIENTS: Patients who do not screen pre-frail or frail from the electronic fitness assessment, except for those patients seen for care in PBTC
- PHASE II PATIENTS: Patients who speak a language other than English, Spanish, Portuguese, Russian, Arabic, Traditional Chinese, or Haitian Creole
- PHASE II PATIENTS: Patients who are not considered appropriate for enrollment due to complex social, medical, or other situation as determined by their primary oncology team
- PHASE II PATIENTS: Participants with psychiatric illness/social situations that would limit compliance with study requirements
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04674267.
Locations matching your search criteria
United States
Massachusetts
Boston
PRIMARY OBJECTIVES:
I. To evaluate the perceived needs of older adults (OA) diagnosed with gastrointestinal malignancies, their identified caregivers, staff, and faculty to characterize the implementation setting at Dana Farber/Brigham and Women's Cancer Center (DF/BWCC) for a geriatric consultation. (Phase I)
II. To refine the proposed Resilience and Equity in Aging, Cancer and Health (REACH) program implementation plan based on qualitative feedback provided by OA patients, their identified caregivers, staff, and faculty. (Phase I)
III. Determine the patient, demographic, social determinants, clinical and disease characteristics of OA associated with emergency department (ED) visits/hospitalization following initial oncology consultation at DF/BWCC in year 2019. (Phase I)
IV. Determine the added benefit of geriatric and pharmacy co-management on interruptions to overall cancer care. (Phase II)
Va. Determine the patient, demographic, social determinants, clinical and disease characteristics of OA diagnosed with gastrointestinal cancer predicting ED visits/hospitalization following initial oncology consultation at DF/BWCC; determine the subset of predictive factors in year 2019 with the potential for modification via the proposed geriatric consultation intervention. (Phase II)
Vb. Determine the association of geriatric consultation with number of ED visits/hospitalization, quality of life, and time to functional decline among OA diagnosed with gastrointestinal cancer randomized to the geriatric consultation intervention. (Phase II)
OUTLINE:
PHASE I:
Patients and caregivers participate in semi-structured interviews, and providers and staff participate in focus groups. Patients complete a frailty assessment.
PHASE II:
Patients complete a frailty assessment. Patients are then randomized to 1 of 2 arms.
ARM I: Patients receive usual care.
ARM II: Patients undergo a geriatric and pharmacy consultation regarding patients’ mood, psychosocial supports, sleep, energy level and cognition, with appropriate counseling/education and interventions wherever appropriate.
After completion of study treatment, patients are followed up for up to 1 year.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorNadine A Jackson
- Primary ID20-275
- Secondary IDsNCI-2021-00576
- ClinicalTrials.gov IDNCT04674267