Cost-Utility Analysis of Home-based Versus Hospital-based Chemotherapy in Multiple Myeloma: Case of Carfilzomib (ADHOMY2)
Carfilzomib is administered in treatment of Multiple Myeloma intravenously on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (days 17 to 28). With COVID pandemic, the investigators had to limit patient visits to the hospital. The treatment protocols were modified by switching to weekly injections of carfilzomib according to the PLEIADES and ARROW 2 studies.
Considering the frequency of intravenous (IV) administration, home-based chemotherapy in Hospital-at-Home (HaH) setting is an attractive and suitable alternative to standard hospital-based chemotherapy in Outpatient-Hospital (OH), and is expected to provide both cost-savings for the Health Insurance (HI) and improvement in patient quality of life (QoL).
The purpose of the study is to assess the cost-utility of home-based compared to hospital-based carfilzomib administration in multiple myeloma.
The investigators are also planning on assessing healthcare resource utilization and related costs, adverse and intercurrent events, and patients' quality of life and satisfaction, for each strategy.
調査の概要
状態
条件
詳細な説明
All participants receive the first cycle of treatment in OH. They are then randomized between exclusive OH treatment and combined treatment in OH and at home with HaH services.
For the HaH group, the first injection of each cycle is delivered in OH. The rest of the cycle is delivered at home by HaH after a clinical examination (by nurse or general practitionner).
Primary and secondary endpoints are collected at day 1 of cycle 3, 6, 9, 12, 18 and one month after the end of treatment.
Participants we leave the protocol prematurely in case of treatment failure, toxicity or if participant ask to. For those patients, the end of study visit will be done one month after ending treatment.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：ANDREIA CARVALHO DE FREITAS
- 電話番号：0383859305
- メール：a.carvalhodefreitas@chru-nancy.fr
研究連絡先のバックアップ
- 名前：Pierre FEUGIER
- 電話番号：0383853283
- メール：p.feugier@chru-nancy.fr
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age > 18 years
- relapsed multiple myeloma, at least one prior line of treatment
- treatment with carfilzomib validated in a multidisciplinary consultation meeting and accepted by the patient
- The patient accepts mixed management and benefits from the support of his/her family and friends (see ANAES 2003 criteria). If the patient does not have a caregiver, he/she can still participate in the research and the absence of a caregiver will be collected.
- Patient capable of adhering to care (cf. ANAES 2003 criteria)
- Patient affiliated to a social security system or beneficiary of such a system.
- Patient having received full information on the organization of the research and having signed his or her informed consent
Exclusion Criteria:
- Person with a contraindication to carfilzomib
- Women of childbearing age who do not have effective contraception
- Persons referred to in articles L. 1121-5, L. 1121-7; L1121-8 and L1122-1-2 of the Public Health Code
- Pregnant woman, parturient or nursing mother
- Minor (not emancipated)
- Adult person under a legal protection measure (guardianship, curatorship, safeguard of justice)
- A person of full age who is unable to express his or her consent
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Carfilzomib delivered in OH only
Patients receive the whole treatment in OH. Primary and secondary endpoints are collected at day 1 of cycle 3, 6, 9, 12, 18 and one month after. Patients leave the protocol prematurely due to treatment failure, toxicity or patient wishes. For those patients, the end of study visit will be done one month after ending treatment. |
Patients receive the whole treatment en OH.
|
|
実験的：Carfilzomib delivered in OH and HaH combined
Patients receive the first cycle of treatment in OH. Then, they are randomized between exclusive OH treatment and combined treatment in OH and at home with HaH services. For the HaH patients group, the first injection of each cycle is delivered in OH. The rest of the cycle is delivered at home by HaH after a clinical examination (by nurse or general practitionner). Primary and secondary endpoints are collected at day 1 of cycle 3, 6, 9, 12, 18 and one month after. Patients leave the protocol prematurely due to treatment failure, toxicity or patient wishes. For those patients, the end of study visit will be done one month after ending treatment. |
Patients receive the first cycle of treatment in OH.
Then, they are randomized between exclusive OH treatment and combined treatment in OH and at home with HaH services.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incremental cost-utility ratio (ICUR) expressed in euros per QALY.
時間枠：Up to 20 months
|
Incremental cost-utility ratio (ICUR) of home-based compared to hospital-based carfilzomib administration in multiple myeloma, expressed in euros per QALY according to EQ-5D-5L questionnaire (EuroQOL 5 dimensions 5 levels) from 0 to 1 (1 being the best state with no problem)
|
Up to 20 months
|
|
Differences of quality of life in cancer patients between each group
時間枠：Up to 20 months
|
Difference of quality of life according to EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire with 30 questions, answer from 1 to 4, 1 being the best state with no problem)
|
Up to 20 months
|
|
Differences of quality of life in myeloma patients between each group
時間枠：Up to 20 months
|
Difference of quality of life according to EORTC QLQ-MY20 questionnaire (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire with 20 questions related to myeloma symptoms, answer from 1 to 4, 1 being the best state with no problem)
|
Up to 20 months
|
|
Cost of care
時間枠：Up to 20 month
|
Cost for Health Insurance by patients, at the end of treament: Total costs per patient and average cost per injection
|
Up to 20 month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Healthcare resource utilization
時間枠：Up to 20 months
|
|
Up to 20 months
|
|
Adverse events related to myeloma treatment
時間枠：Up to 20 months
|
|
Up to 20 months
|
|
Patients and caregivers' satisfaction
時間枠：Up to 20 months
|
- Patients' and Caregivers' Satisfaction Scores at the end of the treatment according to questionnaires with (opened and closes-questions) : 4 questions for OH group 9 questions for OH and HaH group 7 questions for caregiver
|
Up to 20 months
|
協力者と研究者
捜査官
- 主任研究者：Pierre FEUGIER、Central Hospital, Nancy, France
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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