Role of Geriatric Intervention in Treatment of Older Patients With Cancer : a Phase III Randomized Study (PREPARE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 792
- 试验地点
- 50
- 主要终点
- Overall survival defined as the delay between randomization and death, all causes.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 :
- •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).
排除标准
- •Patient who already received 2 medical treatment lines
- •Exclusive 1st or 2nd treatment lines of :
- •Hormonotherapy (except for prostate cancer : abiteratone acetate is allowed),
- •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
- •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
研究组 & 干预措施
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.
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.
干预措施: Geriatrician Intervention (Other)
结局指标
主要结局
Overall survival defined as the delay between randomization and death, all causes.
时间窗: 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.
时间窗: Year 1
次要结局
- 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)
- Overall survival defined as the delay between randomization and death, all causes.(Year 3)
- 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)