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Trial record 1 of 1 for:    2015-A01417-42
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Role of Geriatric Intervention in Treatment of Older Patients With Cancer (PREPARE) (PREPARE)

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ClinicalTrials.gov Identifier: NCT02704832
Recruitment Status : Unknown
Verified November 2017 by Institut Bergonié.
Recruitment status was:  Recruiting
First Posted : March 10, 2016
Last Update Posted : November 20, 2017
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Institut Bergonié

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer Bladder Cancer Ovarian Cancer Lymphoma Other: Geriatrician Intervention Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Role of Geriatric Intervention in Treatment of Older Patients With Cancer : a Phase III Randomized Study (PREPARE)
Study Start Date : March 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2021

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival defined as the delay between randomization and death, all causes. [ Time Frame: Year 1 ]
  2. 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 ]

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

Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704832


Contacts
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Contact: Pierre-Louis SOUBEYRAN, PU-PH +33 5 56 33 32 67 p.soubeyran@bordeaux.unciancer.fr
Contact: Caroline LALET +33 5 56 33 33 47 c.lalet@bordeaux.unicancer.fr

Locations
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Sponsors and Collaborators
Institut Bergonié
Ministry of Health, France
Investigators
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Study Chair: Pierre-Louis SOUBEYRAN, PU-PH Institut Bergonié
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT02704832    
Other Study ID Numbers: IB 2015-08
ID-RCB number 2015-A01417-42 ( Other Identifier: ANSM )
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Institut Bergonié:
Geriatric oncology
Intervention
Case management