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

Pancreatic Cancer Clinical Trial

— REACH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04674267
• Other study ID #: 20-275
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Dana-Farber Cancer Institute
• Contact: Nadine J McCleary, MD, MPH
• Phone: 877-442-3324
• Email: NJ_McCleary[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 257
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Colon Cancer
• Esophageal Cancer
• Gastric Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Pancreatic Cancer
• Rectal Cancer

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of electronic fitness assessment questionnaire (developed from Comprehensive Geriatric Assessment tool)	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.	1 year
Primary	Acceptability of electronic fitness assessment questionnaire	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.	1 year
Primary	Association of geriatric consultation with number of unplanned ED visits/hospitalizations among older adult participants	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.	1 year