Patient-Centered Care for the Older Adult With Hematologic Malignancy
Primary Purpose
Hematologic Malignancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baseline Geriatric Screening/Assessment
Geriatrician Co-Management
Sponsored by
About this trial
This is an interventional other trial for Hematologic Malignancy focused on measuring Hematologic Malignancy, Geriatric Assessment, Geriatric Oncology, Frailty
Eligibility Criteria
Inclusion Criteria:
- All patients aged 75 and older who present for an initial consultation at the Dana-Farber/Brigham and Women's Cancer Center for hematologic malignancy (transplantation consultation excluded).
- Assessed to be pre-frail or frail on formal baseline geriatric assessment.
Exclusion Criteria:
- Not willing to participate
Sites / Locations
- Dana Farber Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Usual Care
Geriatrician Co-Management
Arm Description
Frail/pre-frail hematologic oncology patients receive usual care
Frail/pre-frail hematologic oncology patients receive co-management by a geriatrician
Outcomes
Primary Outcome Measures
Overall Survival
Overall Survival at one year
Secondary Outcome Measures
Full Information
NCT ID
NCT02359838
First Posted
February 2, 2015
Last Updated
March 24, 2022
Sponsor
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT02359838
Brief Title
Patient-Centered Care for the Older Adult With Hematologic Malignancy
Official Title
Patient-Centered Care for the Older Adult With Hematologic Malignancy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research study is evaluating if co-management by a geriatrician embedded in the oncology clinic can improve outcomes for frail older adults with blood cancers. A rigorous pre-entry frailty assessment by a trained research assistant will be followed by randomization to geriatrician co-management versus usual care for patients found to be frail or pre-frail.
Detailed Description
Older adults have unique health concerns, and in particular, older adults with blood cancers may have different disease and other health related issues than younger adults with similar diagnoses. One aspect of aging which can make older adults more vulnerable is frailty. Frailty is a general term that describes a decline in multiple areas of health, including the loss of energy, physical ability, and mental ability. Frailty can make it difficult for patients with cancer to respond to treatment and more likely to have side effects. On the other hand, many older patients are not frail despite advanced age. This study is being done to determine if co-management by a geriatrician of older adults who are found to be frail through a detailed baseline assessment can improve outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy
Keywords
Hematologic Malignancy, Geriatric Assessment, Geriatric Oncology, Frailty
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
Other
Arm Description
Frail/pre-frail hematologic oncology patients receive usual care
Arm Title
Geriatrician Co-Management
Arm Type
Active Comparator
Arm Description
Frail/pre-frail hematologic oncology patients receive co-management by a geriatrician
Intervention Type
Other
Intervention Name(s)
Baseline Geriatric Screening/Assessment
Intervention Description
All patients receive baseline geriatric screening/assessment by a research assistant to determine frailty status.
Intervention Type
Other
Intervention Name(s)
Geriatrician Co-Management
Intervention Description
A board-certified geriatrician embedded in the oncology clinic will co-manage patients randomized to this arm.
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival at one year
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients aged 75 and older who present for an initial consultation at the Dana-Farber/Brigham and Women's Cancer Center for hematologic malignancy (transplantation consultation excluded).
Assessed to be pre-frail or frail on formal baseline geriatric assessment.
Exclusion Criteria:
Not willing to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory A. Abel, MD, MPH
Organizational Affiliation
Dana Faber Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jane A Driver, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Links:
URL
https://doi.org/10.3324/haematol.2021.278802
Description
Randomized controlled trial of geriatric consultation versus standard care in older adults with hematologic malignancies
Learn more about this trial
Patient-Centered Care for the Older Adult With Hematologic Malignancy
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