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

Phase 3

Active, not recruiting

• Conditions: Breast Cancer; Lung Cancer; Colorectal Cancer; Lymphoma; Bladder Cancer; Ovarian Cancer; Prostate Cancer

• Registration Number: NCT02704832
• Lead Sponsor: Institut Bergonié

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 Timeline

• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-03-05
• Study First Posted: 2016-03-10
• Study Start: 2016-09-30
• Primary Completion: 2023-12-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 792

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
For the experimental arm only: Assessment of autonomy using Activities of Daily Living (ADL) questionnaire.	Months 0, 6, 12
6-month response rates defined as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or Cheson criteria.	Month 6
Number of unscheduled hospitalizations.	up to 3 years
For the experimental arm only: Assessment of comorbidities using Cumulative Illness Rating Scale for Geriatrics (CIRS-G) scale.	Months 0, 6, 12
For the experimental arm only: Assessment of nutritional status using mini nutritional assessment (MNA) scale.	Months 0, 6, 12
Toxicity graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.	up to 3 years
Length of unscheduled hospitalizations.	up to 3 years
For the experimental arm only: Assessment of mobility using get-up and Go test.	Months 0, 6, 12
For the experimental arm only: Assessment of autonomy using Instrumental Activities of Daily Living (IADL) questionnaire.	Months 0, 6, 12
For the experimental arm only: Assessment of depression using Geriatric Depression Scale (GDS-15) scale.	Months 0, 6, 12
For the experimental arm only: Assessment of cognitive functions using mini mental state exam (MMSE).	Months 0, 6, 12

Trial Locations

Locations (50)

Centre Hospitalier Universitaire de Grenoble; 🇫🇷 Grenoble, Rhône Alpes, France

Institut de Cancérologie de l'Ouest; 🇫🇷 Angers, France

Centre Hospitalier de Beauvais; 🇫🇷 Beauvais, France

Institut Bergonié Centre Régional de Lutte Contre le Cancer; 🇫🇷 Bordeaux, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Clinique Anne d'Artois; 🇫🇷 Béthune, 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

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