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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674267
Recruitment Status : Not yet recruiting
First Posted : December 19, 2020
Last Update Posted : December 9, 2021
Sponsor:
Information provided by (Responsible Party):
Nadine McCleary MD, MPH, Dana-Farber Cancer Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Other: Focus Group Not Applicable

Detailed 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 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.

    • The research study procedure includes one discussion on the needs of older adult patients receiving cancer care, along with the needs of their caretakers and cancer care team.
    • Patients and caregivers will participate in individual interviews, while staff and faculty will participate in focus groups.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Pre-Implementation Phase

To evaluate the perceived needs of Older Adults A diagnosed with gastrointestinal malignancies, their identified caregivers, staff, and faculty to characterize the implementation setting at DF/BWCC for a geriatric consultation.

To refine the proposed REACH program implementation plan based on qualitative feedback provided by OA patients, their identified caregivers, staff, and faculty.

 Other: Focus Group
Discussions on care needs conducted in a 1:1 interview or group format by phone or video


Outcome Measures
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Primary Outcome Measures :
  1. Patient knowledge [ Time Frame: 1 year ]
    Patient and caregiver knowledge and beliefs about geriatric consultations and the usability of the frailty assessment, along with staff and provider readiness for implementation, will be evaluated utilizing the Consolidated Framework for Implementation Research (CFIR)

  2. Patient beliefs [ Time Frame: 1 year ]
    Patient and caregiver knowledge and beliefs about geriatric consultations and the usability of the frailty assessment, along with staff and provider readiness for implementation, will be evaluated utilizing the Consolidated Framework for Implementation Research (CFIR)

  3. Caregiver knowledge [ Time Frame: 1 year ]
    Patient and caregiver knowledge and beliefs about geriatric consultations and the usability of the frailty assessment, along with staff and provider readiness for implementation, will be evaluated utilizing the Consolidated Framework for Implementation Research (CFIR)

  4. Caregiver beliefs [ Time Frame: 1 year ]
    Patient and caregiver knowledge and beliefs about geriatric consultations and the usability of the frailty assessment, along with staff and provider readiness for implementation, will be evaluated utilizing the Consolidated Framework for Implementation Research (CFIR)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients in the younger-old category of age 70 to 75 years and the older-old category of age 75 years and above.
  • Eligible caregivers

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674267


Contacts
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Contact: Nadine J McCleary, MD, MPH 877-442-3324 njackson2@partners.org

Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Contact: Nadine J McCleary, MD, MPH    877-442-3324    njackson2@partners.org   
Principal Investigator: Nadine J McCleary, MD, MPH         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Nadine J McCleary, MD, MPH Dana-Farber Cancer Institute
More Information
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Responsible Party: Nadine McCleary MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04674267    
Other Study ID Numbers: 20-275
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: December 9, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nadine McCleary MD, MPH, Dana-Farber Cancer Institute:
Gastric Cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases