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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02359838
Other study ID # 14-515
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2015
Est. completion date May 1, 2020

Study information

Verified date March 2022
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date May 1, 2020
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Baseline Geriatric Screening/Assessment
All patients receive baseline geriatric screening/assessment by a research assistant to determine frailty status.
Geriatrician Co-Management
A board-certified geriatrician embedded in the oncology clinic will co-manage patients randomized to this arm.

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 Overall Survival Overall Survival at one year One year
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