Role of Geriatric Intervention in Treatment of Older Patients With Cancer (PREPARE)
PREPARE
2 other identifiers
interventional
792
1 country
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Sep 2016
Longer than P75 for not_applicable breast-cancer
50 active sites
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
First Submitted
Initial submission to the registry
February 19, 2016
CompletedFirst Posted
Study publicly available on registry
March 10, 2016
CompletedStudy Start
First participant enrolled
September 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2025
CompletedJanuary 30, 2026
January 1, 2026
7.3 years
February 19, 2016
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall survival defined as the delay between randomization and death, all causes.
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.
Year 1
Secondary Outcomes (13)
Overall survival defined as the delay between randomization and death, all causes.
Year 3
Health related quality of life (hRQoL) assessed using 3 scales of EORTC QLQ-C30 questionnaire.
Year 3
6-month response rates defined as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or Cheson criteria.
Month 6
Toxicity graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.
up to 3 years
Number of unscheduled hospitalizations.
up to 3 years
- +8 more secondary outcomes
Study Arms (2)
Arm A
NO INTERVENTIONArm 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.
Arm B
EXPERIMENTALArm 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patient older 70 years and older
- Performance status 0 to 3 (WHO)
- G8 and QLQ-C30 questionnaires 'score are available
- No previous geriatric evaluation during cancer treatment
- Locally advanced or metastatic disease :
- st 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)
- Or 2nd line medical treatment :
- Breast cancer : locally advanced or metastatic disease, hormone-resistant and Her2 negative,
- +7 more criteria
You may not qualify if:
- Patient who already received 2 medical treatment lines
- Exclusive 1st or 2nd treatment lines of :
- Hormonotherapy (except for prostate cancer : abiteratone acetate is allowed),
- Surgery,
- Radiotherapy,
- "Best supportive care" treatment
- Patient unable to understand quality of life questionnaire
- Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.
- Patient placed under guardianship
- Previous enrolment in the present study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Bergoniélead
- Ministry of Health, Francecollaborator
Study Sites (50)
Centre Hospitalier Universitaire de Grenoble
Grenoble, Auvergne-Rhône-Alpes, 38043, France
Institut de Cancérologie de l'Ouest
Angers, France
Centre Hospitalier de Beauvais
Beauvais, 60021, France
Clinique Anne d'Artois
Béthune, 62400, France
Institut Bergonié Centre Régional de Lutte Contre le Cancer
Bordeaux, 33076, France
CHU de Bordeaux
Bordeaux, 33600, France
Centre Hospitalier Universitaire de Caen
Caen, 14033, France
Infirmerie Protestante de Lyon
Caluire-et-Cuire, 69300, France
Centre Hospitalier Intercommunal de Castres Mazamet
Castres, 81108, France
Centre Hospitalier Métropôle Savoie Chambéry
Chambéry, 73011, France
Centre Hospitalier de Chinon
Chinon, 37500, France
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63000, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
AP-HP Henri Mondor
Créteil, 94000, France
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010, France
Centre Hospitalier de Dax
Dax, 40107, France
Centre Georges François Leclerc
Dijon, 21079, France
Centre Hospitalier Universitaire de Martinique
Fort de France, 97261, France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000, France
Centre Hospitalier Universitaire de Lille
Lille, 59037, France
Clinique Mutualiste Eugène André
Lyon, 69003, France
Hôpital Saint Joseph Saint Luc
Lyon, 69007, France
Centre Léon Bérard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, 13273, France
Centre Hospitalier de Mont de Marsan
Mont-de-Marsan, 40000, France
Institut de Cancérologie de Montpellier
Montpellier, 34298, France
Institut de Cancérologie de Lorraine
Nancy, 54519, France
Centre Catherine de Sienne
Nantes, 44202, France
Centre Hospitalier Universitaire de Nîmes
Nîmes, 30029, France
AP-HP Hôpital Saint Louis
Paris, 75010, France
Centre Hospitalier de Pau
Pau, 64046, France
Polyclinique Francheville
Périgueux, 24000, France
Hospices Civils de Lyon
Pierre-Bénite, 69495, France
Centre CARIO - HPCA
Pleurin Sur Mer, 22190, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86000, France
Centre Hospitalier René Dubos
Pontoise, 95300, France
Centre Hospitalier Annecy Genevois
Pringy, 74374, France
Centre Hospitalier Intercommunal de Cornouaille
Quimper, 29107, France
Centre Jean Godinot
Reims, 51726, France
Centre Hospitalier Universitaire de Rennes
Rennes, 35033, France
Centre Eugène Marquis
Rennes, 35042, France
Centre Hospitalier Universitaire de Rouen
Rouen, 76031, France
Centre Hospitalier Privé de Saint Grégoire
Saint-Grégoire, 35760, France
Centre Hospitalier Universitaire de Nantes
Saint-Herblain, 44800, France
GHPSO Senlis Creil Picardie
Senlis, 60300, France
Centre Hospitalier de Saint-Malo
St-Malo, 35403, France
Centre Hospitalier Universitaire de Strasbourg
Strasbourg, 67091, France
Institut Claudius Regaud
Toulouse, 31059, France
Centre Hospitalier de Tourcoing
Tourcoing, 59208, France
Centre Hospitalier Universitaire de Tours
Tours, 37170, France
Related Publications (1)
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.
PMID: 27908282DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pierre-Louis SOUBEYRAN, PU-PH
Institut Bergonié
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2016
First Posted
March 10, 2016
Study Start
September 30, 2016
Primary Completion
December 31, 2023
Study Completion
November 21, 2025
Last Updated
January 30, 2026
Record last verified: 2026-01