Role of Geriatric Intervention in Treatment of Older Patients With Cancer (PREPARE) (PREPARE)

November 17, 2017 updated by: Institut Bergonié

Role of Geriatric Intervention in Treatment of Older Patients With Cancer : a Phase III Randomized Study (PREPARE)

Randomized trials have already demonstrated that geriatric intervention was able to improve survival in the general elderly population but only a few have been performed in cancer patients. At the end, these data are not sufficient to consider geriatric intervention as validated in this setting. Case Management, coordinated by a geriatrician and a trained nurse, could improve prognosis of elderly patients with cancer. This approach, can be integrated in daily oncology practice. This strategy will be compared to usual oncological management in a randomized phase III trial.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients will first be screened using the G8 screening tool. If the resulting score is altered (G8 <= 14), patients will be included in the main study and randomized according to 2 modalities: Arm A / Usual care (treatment according to on-going regimens in oncology) or Arm B /Case management (assessment of the patient by the nurse and the geriatrician with interventions as prescribed by the geriatrician). The intervention will be considered effective if, at one year, compared to usual care there is a significant clinical improvement in overall survival (OS) without a significant deterioration or/and clinical improvement of at least one of the targeted quality of life (QoL) scores, without significant clinical deterioration in at least one of the targeted QoL scores and without significant difference in OS in favor of usual care.

If the resulting score is normal (G8 > 14), patients will be treated according to their physician-in-charge opinion. A minimal set of data will be collected (age, sex, tumor type, disease stage, performance status (PS), creatinine clearance, albumin and C-Reactive Protein (CRP) levels mainly) to allow for the characterization of the population in order to compare our results to those of other published series.

Study Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France
        • Recruiting
        • Institut de Cancérologie de l'Ouest
        • Contact:
          • Sophie ABADIE-LACOURTOISIE, MD
      • Beauvais, France, 60021
        • Not yet recruiting
        • Centre Hospitalier de Beauvais
        • Contact:
          • Kamel GHOMARI, MD
      • Bordeaux, France, 33076
        • Recruiting
        • INSTITUT BERGONIE Centre Régional de Lutte Contre le Cancer
        • Contact:
          • Pierre-Louis SOUBEYRAN, PU-PH
      • Bordeaux, France, 33600
        • Recruiting
        • CHU de Bordeaux
        • Contact:
          • Jean-Frédéric BLANC, PU-PH
      • Béthune, France, 62400
        • Not yet recruiting
        • Clinique Anne d'Artois
      • Caen, France, 14033
        • Recruiting
        • Centre Hospitalier Universitaire de Caen
        • Contact:
          • Jeannick MADELAINE, MD
      • Caluire-et-Cuire, France, 69300
        • Recruiting
        • Infirmerie Protestante de Lyon
        • Contact:
          • Sophie HUMBLOT, MD
      • Castres, France, 81108
        • Recruiting
        • Centre Hospitalier Intercommunal de Castres Mazamet
        • Contact:
          • Hazem Georges HASWANI, MD
      • Chambéry, France, 73011
        • Recruiting
        • Centre Hospitalier Métropôle Savoie Chambéry
        • Contact:
          • Isabelle CAUVIN, MD
      • Chinon, France, 37500
        • Recruiting
        • Centre Hospitalier de Chinon
        • Contact:
          • Sylvie GERARD, MD
      • Clermont-Ferrand, France, 63011
        • Recruiting
        • Centre Jean Perrin
        • Contact:
          • Xavier Durando, MD
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • Centre Hospitalier Universitaire de Clermont-Ferrand
        • Contact:
          • Jacques Olivier BAY, PU-PH
      • Créteil, France, 94010
        • Recruiting
        • Centre Hospitalier Intercommunal de Créteil
        • Contact:
          • Christos CHOUAID, MD
      • Créteil, France, 94000
        • Recruiting
        • AP-HP Henri Mondor
        • Contact:
          • Christophe TOURNIGAND, PU-PH
      • Dax, France, 40107
        • Recruiting
        • Centre Hospitalier de Dax
        • Contact:
          • Laure GAUTIER-FELIZOT, MD
      • Dijon, France, 21079
        • Recruiting
        • Centre Georges Francois Leclerc
        • Contact:
          • Leila BENGRINE-LEFEVRE, MD
      • Fort De France, France, 97261
        • Recruiting
        • Centre Hospitalier Universitaire de Martinique
        • Contact:
          • Nathalie GROSSAT, MD
      • Le Puy-en-Velay, France, 43000
        • Not yet recruiting
        • Centre Hospitalier Emile Roux
        • Contact:
          • Vanessa PANTE, MD
      • Lille, France, 59037
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Lille
        • Contact:
          • Christophe DESAUW, MD
      • Lyon, France, 69373
        • Recruiting
        • Centre Leon Berard
        • Contact:
          • Catherine TERRET, MD
      • Lyon, France, 69003
        • Not yet recruiting
        • Clinique Mutualiste Eugène André
        • Contact:
          • Cécile FOURNEL-FEDERICO, MD
      • Lyon, France, 69007
        • Recruiting
        • hôpital Saint Joseph Saint Luc
        • Contact:
          • Denis PERE-VERGE, MD
      • Marseille, France, 13273
        • Recruiting
        • Institut Paoli Calmettes
        • Contact:
          • Frédérique ROUSSEAU, MD
      • Mont de Marsan, France, 40000
        • Recruiting
        • Centre Hospitalier de Mont de Marsan
      • Montpellier, France, 34298
        • Not yet recruiting
        • Institut de Cancérologie de Montpellier
        • Contact:
          • Fabienne PORTALES, MD
      • Nancy, France, 54519
        • Recruiting
        • Institut de Cancérologie de Lorraine
        • Contact:
          • Cécile DELATTRE, MD
      • Nantes, France, 44202
        • Recruiting
        • Centre Catherine de Sienne
        • Contact:
          • Claude EL KOURI, MD
      • Nîmes, France, 30029
        • Recruiting
        • Centre Hospitalier Universitaire de Nîmes
        • Contact:
          • Nadine HOUEDE, PU-PH
      • Paris, France, 75010
        • Recruiting
        • AP-HP Hôpital Saint Louis
      • Pau, France, 64046
        • Recruiting
        • Centre Hospitalier de Pau
        • Contact:
          • Corinne DAGADA, MD
      • Pierre Bénite, France, 69495
        • Not yet recruiting
        • Hospices Civils de Lyon
      • Pleurin Sur Mer, France, 22190
        • Recruiting
        • Centre CARIO - HPCA
      • Poitiers, France, 86000
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers
        • Contact:
          • Patrick BOUCHAERT, MD
      • Pontoise, France, 95300
        • Not yet recruiting
        • Centre Hospitalier Rene Dubos
      • Pringy, France, 74374
        • Recruiting
        • Centre Hospitalier Annecy Genevois
        • Contact:
          • Laetitia STEFANI, MD
      • Périgueux, France, 24000
        • Recruiting
        • Polyclinique Francheville
        • Contact:
          • Laurent CANY, MD
      • Quimper, France, 29107
        • Recruiting
        • Centre Hospitalier Intercommunal de Cornouaille
        • Contact:
          • Delphine MOLLON, MD
      • Reims, France, 51726
        • Recruiting
        • Centre Jean Godinot
      • Rennes, France, 35042
        • Recruiting
        • Centre Eugène Marquis
      • Rennes, France, 35033
        • Recruiting
        • Centre Hospitalier Universitaire de Rennes
      • Rouen, France, 76031
        • Recruiting
        • Centre Hospitalier Universitaire de Rouen
        • Contact:
          • Pierre MICHEL, PU-PH
      • Saint Grégoire, France, 35760
        • Recruiting
        • Centre hospitalier privé de Saint Grégoire
        • Contact:
          • Anne MERCIER-BLAS
      • Saint Herblain, France, 44800
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes
        • Contact:
          • Stéphanie BORDENAVE, MD
      • Saint-Malo, France, 35403
        • Recruiting
        • Centre Hospitalier de Saint-Malo
        • Contact:
          • Hervé DESCLOS, MD
      • Senlis, France, 60300
        • Recruiting
        • GHPSO Senlis Creil Picardie
      • Strasbourg, France, 67091
        • Recruiting
        • Centre Hospitalier Universitaire de Strasbourg
      • Toulouse, France, 31059
        • Recruiting
        • Institut Claudius Regaud
        • Contact:
          • Loïc MOUREY, MD
      • Tourcoing, France, 59208
        • Not yet recruiting
        • Centre Hospitalier de Tourcoing
      • Tours, France, 37170
        • Recruiting
        • Centre Hospitalier Universitaire de Tours
    • Rhône Alpes
      • Grenoble, Rhône Alpes, France, 38043
        • Recruiting
        • Centre Hospitalier Universitaire de Grenoble
        • Contact:
          • Hervé CURE, PU-PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient older 70 years and older
  2. Performance status 0 to 3 (WHO)
  3. G8 and QLQ-C30 questionnaires 'score are available
  4. No previous geriatric evaluation during cancer treatment

  5. Locally advanced or metastatic disease :

    1. 1st line medical treatment :

      • Breast cancer : locally advanced or metastatic disease, hormone-resistant and Her2 negative,
      • Colon and rectum : metastatic (unresectable metastasis),
      • Prostate cancer : metastatic and refractory to hormonal castration,
      • Bladder cancer : locally advanced or metastatic,
      • Ovarian cancer : advanced stage (IIb to IV),
      • Lung cancer : metastatic non-small cell,
      • Lymphomas (indolent and aggressive)

    2. Or 2nd line medical treatment :

      • Breast cancer : locally advanced or metastatic disease, hormone-resistant and Her2 negative,
      • Colon and rectum : metastatic (unresectable metastasis),
      • Prostate cancer : metastatic and refractory to hormonal castration,
      • Ovarian cancer : advanced stage (IIb to IV),
      • Lymphomas (indolent and aggressive)
  6. Life expectancy over 6 months
  7. Signed informed consent
  8. Patients with a French social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code).

Exclusion Criteria:

  1. Patient who already received 2 medical treatment lines

  2. Exclusive 1st or 2nd treatment lines of :

    • Hormonotherapy (except for prostate cancer : abiteratone acetate is allowed),
    • Surgery,
    • Radiotherapy,
  3. "Best supportive care" treatment
  4. Patient unable to understand quality of life questionnaire
  5. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.
  6. Patient placed under guardianship
  7. Planned concomitant participation to another medical interventional trial during the 12 months following the inclusion in the randomized study PREPARE
  8. Previous enrolment in the present study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Arm A
Arm A "Standard oncological care": patients will be treated according to daily oncological practices as defined for each type of cancer, in the "Management protocol of Oncology" written and validated by a group of expert oncologists. The quality of life will be assessed every 3 months during the first year and at 18 months. The study's follow-up will last until 3 years after the enrollment of the last patient and data on vital status of the patient, weight, place of life and the status of the disease will be collected every 6 months.
EXPERIMENTAL: Arm B

Arm B "Geriatrician Intervention": patients will be treated according to the same "Management protocol of Oncology" than patients in the arm "Standard oncological care".

  • Before the beginning of the medical treatment, a comprehensive geriatric assessment will be performed by the geriatrician and the nurse that will define a plan of geriatric management care, according to the "Management protocol of Geriatrics".
  • The nurse, under the supervision of a geriatrician, will monitor implemented geriatric interventions. Phone follow-up will be performed every month for 6 months and at 9 months or during any change of situation according to a pre-established phone call plan. A full geriatric assessment by the geriatrician and the nurse will be performed at 6 and 12 months.
Other: Geriatrician Intervention
Arm B : The duration of the geriatric intervention will be 12 months. The quality of life will be assessed every 3 months during the first year and at 18 months. The study's follow-up will last until 3 years after the enrollment of the last patient and data on vital status of the patient, weight, place of life and the status of the disease will be collected every 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival defined as the delay between randomization and death, all causes.
Time Frame: Year 1
Year 1
Health related quality of life (HR-QoL) assessed using 3 scales of European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.
Time Frame: Year 1
Year 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival defined as the delay between randomization and death, all causes.
Time Frame: Year 3
Year 3
Health related quality of life (hRQoL) assessed using 3 scales of EORTC QLQ-C30 questionnaire.
Time Frame: Year 3
Year 3
6-month response rates defined as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or Cheson criteria.
Time Frame: Month 6
Month 6
Toxicity graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.
Time Frame: up to 3 years
up to 3 years
Number of unscheduled hospitalizations.
Time Frame: up to 3 years
up to 3 years
Length of unscheduled hospitalizations.
Time Frame: up to 3 years
up to 3 years
For the experimental arm only: Assessment of autonomy using Activities of Daily Living (ADL) questionnaire.
Time Frame: Months 0, 6, 12
Months 0, 6, 12
For the experimental arm only: Assessment of autonomy using Instrumental Activities of Daily Living (IADL) questionnaire.
Time Frame: Months 0, 6, 12
Months 0, 6, 12
For the experimental arm only: Assessment of depression using Geriatric Depression Scale (GDS-15) scale.
Time Frame: Months 0, 6, 12
Months 0, 6, 12
For the experimental arm only: Assessment of cognitive functions using mini mental state exam (MMSE).
Time Frame: Months 0, 6, 12
Months 0, 6, 12
For the experimental arm only: Assessment of comorbidities using Cumulative Illness Rating Scale for Geriatrics (CIRS-G) scale.
Time Frame: Months 0, 6, 12
Months 0, 6, 12
For the experimental arm only: Assessment of nutritional status using mini nutritional assessment (MNA) scale.
Time Frame: Months 0, 6, 12
Months 0, 6, 12
For the experimental arm only: Assessment of mobility using get-up and Go test.
Time Frame: Months 0, 6, 12
Months 0, 6, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Collaborators

Ministry of Health, France

Investigators

  • Study Chair: Pierre-Louis SOUBEYRAN, PU-PH, Institut Bergonié

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ANTICIPATED)

February 1, 2019

Study Completion (ANTICIPATED)

February 1, 2021

Study Registration Dates

First Submitted

February 19, 2016

First Submitted That Met QC Criteria

March 5, 2016

First Posted (ESTIMATE)

March 10, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IB 2015-08
  • ID-RCB number 2015-A01417-42 (OTHER: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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