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

NCT ID: NCT02704832

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 792 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2025-11-21

Brief Summary

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.

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.

Conditions

Breast Cancer; Colorectal Cancer; Lung Cancer; Prostate Cancer; Bladder Cancer; Ovarian Cancer; Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Geriatrician Intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre-Louis SOUBEYRAN, PU-PH

Role: STUDY_CHAIR

Institut Bergonié

Locations

Centre Hospitalier Universitaire de Grenoble

Grenoble, Auvergne-Rhône-Alpes, France

Institut de Cancérologie de l'Ouest

Angers, , France

Centre Hospitalier de Beauvais

Beauvais, , France

Clinique Anne d'Artois

Béthune, , France

Institut Bergonié Centre Régional de Lutte Contre le Cancer

Bordeaux, , France

CHU de Bordeaux

Bordeaux, , France

Centre Hospitalier Universitaire de Caen

Caen, , France

Infirmerie Protestante de Lyon

Caluire-et-Cuire, , France

Centre Hospitalier Intercommunal de Castres Mazamet

Castres, , France

Centre Hospitalier Métropôle Savoie Chambéry

Chambéry, , France

Centre Hospitalier de Chinon

Chinon, , France

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, , France

Centre Jean Perrin

Clermont-Ferrand, , France

AP-HP Henri Mondor

Créteil, , France

Centre Hospitalier Intercommunal de Créteil

Créteil, , France

Centre Hospitalier de Dax

Dax, , France

Centre Georges François Leclerc

Dijon, , France

Centre Hospitalier Universitaire de Martinique

Fort de France, , France

Centre Hospitalier Emile Roux

Le Puy-en-Velay, , France

Centre Hospitalier Universitaire de Lille

Lille, , France

Clinique Mutualiste Eugène André

Lyon, , France

Hôpital Saint Joseph Saint Luc

Lyon, , France

Centre Léon Bérard

Lyon, , France

Institut Paoli Calmettes

Marseille, , France

Centre Hospitalier de Mont de Marsan

Mont-de-Marsan, , France

Institut de Cancérologie de Montpellier

Montpellier, , France

Institut de Cancérologie de Lorraine

Nancy, , France

Centre Catherine de Sienne

Nantes, , France

Centre Hospitalier Universitaire de Nîmes

Nîmes, , France

AP-HP Hôpital Saint Louis

Paris, , France

Centre Hospitalier de Pau

Pau, , France

Polyclinique Francheville

Périgueux, , France

Hospices Civils de Lyon

Pierre-Bénite, , France

Centre CARIO - HPCA

Pleurin Sur Mer, , France

Centre Hospitalier Universitaire de Poitiers

Poitiers, , France

Centre Hospitalier René Dubos

Pontoise, , France

Centre Hospitalier Annecy Genevois

Pringy, , France

Centre Hospitalier Intercommunal de Cornouaille

Quimper, , France

Centre Jean Godinot

Reims, , France

Centre Hospitalier Universitaire de Rennes

Rennes, , France

Centre Eugène Marquis

Rennes, , France

Centre Hospitalier Universitaire de Rouen

Rouen, , France

Centre Hospitalier Privé de Saint Grégoire

Saint-Grégoire, , France

Centre Hospitalier Universitaire de Nantes

Saint-Herblain, , France

GHPSO Senlis Creil Picardie

Senlis, , France

Centre Hospitalier de Saint-Malo

St-Malo, , France

Centre Hospitalier Universitaire de Strasbourg

Strasbourg, , France

Institut Claudius Regaud

Toulouse, , France

Centre Hospitalier de Tourcoing

Tourcoing, , France

Centre Hospitalier Universitaire de Tours

Tours, , France

Countries

France

References

Soubeyran P, Terret C, Bellera C, Bonnetain F, Jean OS, Galvin A, Chakiba C, Zwolakowski MD, Mathoulin-Pelissier S, Rainfray M. Role of geriatric intervention in the treatment of older patients with cancer: rationale and design of a phase III multicenter trial. BMC Cancer. 2016 Dec 1;16(1):932. doi: 10.1186/s12885-016-2927-4.

Reference Type: DERIVED

PMID: 27908282 (View on PubMed)

Other Identifiers

ID-RCB number 2015-A01417-42

Identifier Type: OTHER

Identifier Source: secondary_id

IB 2015-08

Identifier Type: -

Identifier Source: org_study_id