NCT03059875

Brief Summary

The risk of diagnosis of cancer increases with age, especially breast cancer in elderly women. Elderly population is heterogeneous, regarding physiological reserves, comorbidities, disability and geriatric conditions. Comprehensive geriatric assessment (CGA) is a multidimensional approach to determine geriatric profile, in helping the therapeutic strategy. In-patients with diagnosis of cancer are screened with the FOG (oncology geriatric filter), to identify vulnerable subjects who may benefit from CGA. This scale of ten questions includes geriatric domains such as functional status, nutrition, mood, cognitive abilities and comorbidities. In elderly patients with breast cancer considered as fit (FOG=0), CGA is not necessary before adjuvant treatment. In vulnerable patients (FOG ≤ 1 and \< 3), CGA is held in routine to discuss the adjuvant therapy feasibility. Patients with FOG ≥ 4 underwent CGA if palliative care is considered. Patients in the intermediate group (FOG 1-3) are randomized to determine time of CGA, before or after surgery. The aims of this study are to assess the outcomes regarding the time of CGA, in elderly female patients with breast cancer management, and to define the optimal place of CGA in care pathway.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
79

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable surgery

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2014

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

7.5 years

First QC Date

February 9, 2017

Last Update Submit

September 28, 2021

Conditions

Surgery75 Years Old and MoreFemale Breast Cancer

Keywords

BreastcancerStandardized Geriatric EvaluationOnco-Geriatric Filter

Outcome Measures

Primary Outcomes (1)

  • Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery

    5 years

Secondary Outcomes (5)

  • Quality of life of patients

    5 years

  • Patient satisfaction with their management

    5 years

  • Compare proportions of patients who received adjuvant chemotherapy and / or radiation standard

    5 years

  • Compare time to take care of Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery

    5 years

  • Compare the proportions of patients receiving adjuvant therapy, including complete hormone therapy

    5 years

Study Arms (2)

Strategy A

OTHER

Comprehensive Geriatric Assessment before the surgery of breast

Behavioral: Medical consultation for a Standardized Geriatric Evaluation

Strategy B

OTHER

Comprehensive Geriatric Assessment after the surgery of breast

Behavioral: Medical consultation for a Standardized Geriatric Evaluation

Interventions

Medical consultation for a Standardized Geriatric EvaluationBEHAVIORAL
Strategy AStrategy B

Eligibility Criteria

Age75 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • First breast cancer localized, indication of surgery
  • Onco-geriatric filter (FOG) \>= 1 ou \< 4

You may not qualify if:

  • Male, less of 75 years old
  • Contraindication of surgery
  • Breast cancer with metastasis
  • Onco-geriatric filter (FOG) = 0 or 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Center

Angoulême, 16959, France

Location

Hospital center

Bressuire, 79302, France

Location

Hospital Center

La Rochelle, 17019, France

Location

Hospital center

Niort, 79021, France

Location

University Hospital Center

Poitiers, 86000, France

Location

Hospital center

Saintes, 17108, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 23, 2017

Study Start

January 30, 2014

Primary Completion

July 31, 2021

Study Completion

July 31, 2025

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

FR(6)