Breast CancerPREPARENCT02704832
Role of Geriatric Intervention in Treatment of Older Patients With Cancer (PREPARE)
A study testing Geriatrician Intervention in people with Breast Cancer and Colorectal Cancer, run by Institut Bergonié at 50 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Lung Cancer
- What is being tested?
- Geriatrician Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 792 participants
- Where
- 50 sitesFrance
- Study dates
- 30 Sep 2016to 5 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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 :
- 1st line medical treatment :
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- 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,
- 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)
- Life expectancy over 6 months
- Signed informed consent
- 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).
Who cannot join
- 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
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- 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
- Planned concomitant participation to another medical interventional trial during the 12 months following the inclusion in the randomized study PREPARE
- Previous enrolment in the present study
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
France50 sites
Institut de Cancérologie de l'Ouest
Angers
Centre Hospitalier de Beauvais
Beauvais, 60021
Clinique Anne d'Artois
Béthune, 62400
Institut Bergonié Centre Régional de Lutte Contre le Cancer
Bordeaux, 33076
CHU de Bordeaux
Bordeaux, 33600
Centre Hospitalier Universitaire de Caen
Caen, 14033
Infirmerie Protestante de Lyon
Caluire-et-Cuire, 69300
Centre Hospitalier Intercommunal de Castres Mazamet
Castres, 81108
Centre Hospitalier Métropôle Savoie Chambéry
Chambéry, 73011
Centre Hospitalier de Chinon
Chinon, 37500
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63000
Centre Jean Perrin
Clermont-Ferrand, 63011
AP-HP Henri Mondor
Créteil, 94000
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Centre Hospitalier de Dax
Dax, 40107
Centre Georges François Leclerc
Dijon, 21079
Centre Hospitalier Universitaire de Martinique
Fort de France, 97261
Centre Hospitalier Universitaire de Grenoble
Grenoble, Auvergne-Rhône-Alpes, 38043
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000
Centre Hospitalier Universitaire de Lille
Lille, 59037
Clinique Mutualiste Eugène André
Lyon, 69003
Hôpital Saint Joseph Saint Luc
Lyon, 69007
Centre Léon Bérard
Lyon, 69373
Institut Paoli Calmettes
Marseille, 13273
Centre Hospitalier de Mont de Marsan
Mont-de-Marsan, 40000
Institut de Cancérologie de Montpellier
Montpellier, 34298
Institut de Cancérologie de Lorraine
Nancy, 54519
Centre Catherine de Sienne
Nantes, 44202
Centre Hospitalier Universitaire de Nîmes
Nîmes, 30029
AP-HP Hôpital Saint Louis
Paris, 75010
Centre Hospitalier de Pau
Pau, 64046
Polyclinique Francheville
Périgueux, 24000
Hospices Civils de Lyon
Pierre-Bénite, 69495
Centre CARIO - HPCA
Pleurin Sur Mer, 22190
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86000
Centre Hospitalier René Dubos
Pontoise, 95300
Centre Hospitalier Annecy Genevois
Pringy, 74374
Centre Hospitalier Intercommunal de Cornouaille
Quimper, 29107
Centre Jean Godinot
Reims, 51726
Centre Hospitalier Universitaire de Rennes
Rennes, 35033
Centre Eugène Marquis
Rennes, 35042
Centre Hospitalier Universitaire de Rouen
Rouen, 76031
Centre Hospitalier Privé de Saint Grégoire
Saint-Grégoire, 35760
Centre Hospitalier Universitaire de Nantes
Saint-Herblain, 44800
GHPSO Senlis Creil Picardie
Senlis, 60300
Centre Hospitalier de Saint-Malo
St-Malo, 35403
Centre Hospitalier Universitaire de Strasbourg
Strasbourg, 67091
Institut Claudius Regaud
Toulouse, 31059
Centre Hospitalier de Tourcoing
Tourcoing, 59208
Centre Hospitalier Universitaire de Tours
Tours, 37170
About this study
Official title: 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.
Read the 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
- Being tested
- Geriatrician Intervention
- Keywords
- Geriatric oncology, Intervention, Case management
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Urinary Bladder Neoplasms, Ovarian Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatrician InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | No intervention | 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. |
| Arm B | Experimental | 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. Receives: Other: Geriatrician Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival defined as the delay between randomization and death, all causes.
Measured: 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.
Measured: Year 1
Secondary outcomes (13)
Overall survival defined as the delay between randomization and death, all causes.
Measured: Year 3
Health related quality of life (hRQoL) assessed using 3 scales of EORTC QLQ-C30 questionnaire.
Measured: Year 3
6-month response rates defined as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or Cheson criteria.
Measured: Month 6
Toxicity graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.
Measured: up to 3 years
Number of unscheduled hospitalizations.
Measured: up to 3 years
Length of unscheduled hospitalizations.
Measured: up to 3 years
For the experimental arm only: Assessment of autonomy using Activities of Daily Living (ADL) questionnaire.
Measured: Months 0, 6, 12
For the experimental arm only: Assessment of autonomy using Instrumental Activities of Daily Living (IADL) questionnaire.
Measured: Months 0, 6, 12
For the experimental arm only: Assessment of depression using Geriatric Depression Scale (GDS-15) scale.
Measured: Months 0, 6, 12
For the experimental arm only: Assessment of cognitive functions using mini mental state exam (MMSE).
Measured: Months 0, 6, 12
For the experimental arm only: Assessment of comorbidities using Cumulative Illness Rating Scale for Geriatrics (CIRS-G) scale.
Measured: Months 0, 6, 12
For the experimental arm only: Assessment of nutritional status using mini nutritional assessment (MNA) scale.
Measured: Months 0, 6, 12
For the experimental arm only: Assessment of mobility using get-up and Go test.
Measured: Months 0, 6, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study start30 Sep 2016
- Primary completion31 Dec 2023
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 792 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Pierre-Louis SOUBEYRAN, PU-PH, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704832
- Sponsor's protocol ID
- IB 2015-08
- Other IDs
- ID-RCB number 2015-A01417-42
- Acronym
- PREPARE
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2016
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 27908282
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Geriatric Intervention in Treatment of Older Patients With Cancer : a Phase III Randomized Study (PREPARE)
- ClinicalTrials.gov ID
- NCT02704832
- Acronym / sponsor ID
- PREPARE / IB 2015-08
- Conditions
- Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer, Bladder Cancer, Ovarian Cancer
- Keywords
- Geriatric oncology, Intervention, Case management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 792 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | No intervention | –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. |
| Arm B | Experimental | Other: Geriatrician InterventionArm 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (22 listed)
- 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 :
Key exclusion criteria (11 listed)
- Patient who already received 2 medical treatment lines
- Exclusive 1st or 2nd treatment lines of :
- "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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatrician InterventionArm 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. | Other | Arm B |
Primary outcome
Overall survival defined as the delay between randomization and death, all causes.
Time frame: 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
13 secondary outcomes
Overall survival defined as the delay between randomization and death, all causes.
Time frame: Year 3
Health related quality of life (hRQoL) assessed using 3 scales of EORTC QLQ-C30 questionnaire.
Time frame: 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
Toxicity graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.
Time frame: up to 3 years
Number of unscheduled hospitalizations.
Time frame: up to 3 years
Length of unscheduled hospitalizations.
Time frame: 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
For the experimental arm only: Assessment of autonomy using Instrumental Activities of Daily Living (IADL) questionnaire.
Time frame: 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
For the experimental arm only: Assessment of cognitive functions using mini mental state exam (MMSE).
Time frame: 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
For the experimental arm only: Assessment of nutritional status using mini nutritional assessment (MNA) scale.
Time frame: Months 0, 6, 12
For the experimental arm only: Assessment of mobility using get-up and Go test.
Time frame: Months 0, 6, 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 27908282Soubeyran 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Louis SOUBEYRAN, PU-PH study chair
Institut Bergonié
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatrician Intervention in people with Breast Cancer and Colorectal Cancer, run by Institut Bergonié at 50 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival defined as the delay between randomization and death, all causes. (time frame: Year 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02704832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.