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

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

Tracking Information

• First Submitted Date: February 19, 2016
• First Posted Date: March 10, 2016
• Last Update Posted Date: November 20, 2017
• Study Start Date: March 2016
• Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 5, 2016)

• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 5, 2016)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Role of Geriatric Intervention in Treatment of Older Patients With Cancer (PREPARE)
• Official Title: Role of Geriatric Intervention in Treatment of Older Patients With Cancer : a Phase III Randomized Study (PREPARE)
• 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other

Condition

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

Intervention

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.

Study Arms

• 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.
  Intervention: Other: Geriatrician Intervention

• Publications *: Soubeyran P, Terret C, Bellera C, Bonnetain F, Jean OS, Galvin A, Chakiba C, Zwolakowski MD, Mathoulin-Pélissier 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 5, 2016): 1500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2021
• Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 70 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02704832
• Other Study ID Numbers: IB 2015-08; ID-RCB number 2015-A01417-42 ( Other Identifier: ANSM )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Institut Bergonié
• Study Sponsor: Institut Bergonié
• Collaborators: Ministry of Health, France

Investigators

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

• PRS Account: Institut Bergonié
• Verification Date: November 2017