GEriatric Determinants of Curative RAdiotherapy Scheme Choice for Breast Cancer ELderly Patient Treatment Compliance and Tolerance (GERABEL)

GEriatric Determinants of Curative RAdiotherapy Scheme Choice for Breast Cancer ELderly Patient Treatment Compliance and Tolerance : GERABEL Study

This study proposes an onco geriatric evaluation (Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests) for elderly breast cancer patients. The score obtained at this evaluation will determine the radiotherapy scheme.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Onco Geriatric Evaluation

Detailed Description

Breast cancer is the most frequent cancer for elderly women and represents the first mortality cause for them. Breast cancer incidence increases for elderly women and will become a major public health problem in the next years.

The principal therapeutic solution is the partial mastectomy associated to radiotherapy. However, the radiotherapy scheme and its role are debated for elderly patients. Hypo fractionated radiotherapy could be considered as an advantageous option.

The treatment duration (6,5 weeks) and direct and indirect fatigue (around 33 travels) are major cons. Thereby, for elderly patients, the selection of patients who will benefit from a shorter treatment could be really difficult. It would be interesting to define an objective scoring, predicting a bad or good tolerance and observance to the radiotherapy. Nowadays, onco geriatric evaluations are used to decide some treatment's decision, but no study compared different orientated radiotherapy schemes.

The present study proposes an onco geriatric evaluation leading to a score according to seven tests (Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests). The score will then determine an adapted radiotherapy scheme.

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Puy-en-Velay, France, 43000
    • Centre Hospitalier Emile ROUX
  • Montelimar, France, 26216
    • Groupement Hospitalier portes de Provence
  • Saint-Priest en Jarez, France, 42270
    • Institut de Cancérologie Lucien Neuwirth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Woman more than 70 years old,
• Patient carrying a breast cancer proven histologically and treated by radiotherapy in curative intent.

Exclusion Criteria:

• Man,
• Patient with metastatic cancer,
• Patient with impossible follow-up at 6 months (planned relocation, patient support in another Center),
• Patient under protection of justice or unable to give consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Score of the Onco Geriatric Evaluation between 200 et 160; According to the score obtained with the onco geriatric evaluation, patients with a score between 200 and 160 will receive a normo fractionated radiotherapy (66 Grays in 33 fractions). This scheme of radiotherapy is already used in the clinical practice, but not allocated according to a score obtained at an oncogeriatric evaluation.	Other: Onco Geriatric Evaluation; Seven tests will be performed by an onco geriatrician : Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests. Those tests lead to a score, and this score will determine the scheme of patients radiotherapy.
Experimental: Score of the Onco Geriatric Evaluation between 159 et 120; According to the score obtained with the onco geriatric evaluation, patients with a score between 159 and 120 will receive an hypo fractionated radiotherapy (42,56 Grays in 16 fractions). This scheme of radiotherapy is already used in the usual practice, but not allocated according to a score obtained at an oncogeriatric evaluation.	Other: Onco Geriatric Evaluation; Seven tests will be performed by an onco geriatrician : Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests. Those tests lead to a score, and this score will determine the scheme of patients radiotherapy.
Experimental: Score of the Onco Geriatric Evaluation inferior to 119; According to the score obtained with the onco geriatric evaluation, patients with a score inferior to 119 will receive a large hypo fractionated radiotherapy (30 Grays in 5 weekly fractions). This scheme of radiotherapy is already used in the usual practice, but not allocated according to a score obtained at an oncogeriatric evaluation.	Other: Onco Geriatric Evaluation; Seven tests will be performed by an onco geriatrician : Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests. Those tests lead to a score, and this score will determine the scheme of patients radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of the tolerance	Tolerance is considered as " bad " if the score of the onco geriatric evaluation decreases of more than 20% from the initial evaluation to 6 months after the end of the rays. Tolerance is considered as "correct" in the other cases.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance	Specific tolerance will be evaluated by the number of radiation-induced toxicities (Common Terminology Criteria for Adverse Events 4.4) of I, II, III, and IV grades.	Month 6
Quality of Life Questionnaire	Quality of life will be assessed with the difference between the Quality of Life Questionnaire 30 of the European Organisation for Research and Treatment of Cancer (EORTC) score obtained before the radiotherapy and 6 months after the end of the radiation therapy.	Month 6
Radiotherapy compliance	Compliance is considered as "bad" if the treatment plan is interrupted for at least one day (for medical reason). Compliance is considered as "correct" in the other cases.	Month 6
Correlation between tolerance and distance from the therapeutic center	Correlation will potentially be established between patient general tolerance and the distance between home and radio therapeutic center.	Month 6
Correlation between tolerance and way of transport	Correlation will potentially be established between patient general tolerance and the way of transport used by the patient to go to the therapeutic center.	Month 6
Correlation between tolerance and the number of concomitant treatments	Correlation will potentially be established between patient general tolerance and the number of concomitant treatments.	Month 6
Correlation between tolerance and the nature of concomitant treatments	Correlation will potentially be established between patient general tolerance and the nature of concomitant treatments.	Month 6
Correlation between tolerance and the supportive cares	Correlation will potentially be established between patient general tolerance and the supportive cares performed.	Month 6

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Institut de Cancérologie de la Loire; Centre Antoine Lacassagne

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2016
• Primary Completion (Actual): June 26, 2020
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimate): December 16, 2016

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; Radiotherapy; Onco Geriatric Evaluation; Hypo fractionated radiotherapy; Normo fractionated radiotherapy; Large hypo fractionated radiotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2016-0902 (Other Identifier: M D Anderson Cancer Center); 2016-A01469-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO