Treatment Patterns in Metastatic Prostate Cancer
2018年1月24日 更新者：Bayer
Treatment Patterns, Mortality, Healthcare Resource Utilization, and Costs in Patients With Prostate Cancer With Bone Metastases: A Retrospective Database Analysis .
This study will evaluate treatment patterns, mortality, healthcare resource utilization, and costs in patients with prostate cancer with bone metastases (primary objectives).
Additionally, this study will evaluate opioid/analgesic use among lines of therapy in this patient population (secondary objective).
The study is descriptive in nature and is meant to provide a greater understanding of the patterns of therapy observed in real-world clinical practice (in the absence of clear guideline recommendations with regards to treatment sequencing), to contribute to a greater understanding of the major cost drivers (thus better-informing payers), and to examine real-world mortality in such patients.
調査の概要
研究の種類
観察的
入学 (実際)
565
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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New Jersey
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Whippany、New Jersey、アメリカ
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
45年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
サンプリング方法
非確率サンプル
調査対象母集団
Part 1 - Assessment of treatment patterns, healthcare resource utilization, and costs The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
Part 2 - Assessment of mortality The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
説明
Inclusion Criteria:
- Subjects with at least one claim with a primary diagnosis of prostate cancer (International Classification of Diseases(ICD) Clinical Modification (CM)185.xx )and any of the below on same day or after the prostate cancer claim:
- At least one inpatient claim with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or Healthcare Common Procedure Coding System (HCPCS) code for a treatment indicative of bone metastases OR
- At least two outpatient claims with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or HCPCS code for a treatment indicative of bone metastases, with a minimum of 30 days between claims.
Exclusion Criteria:
- Subjects with a diagnosis of a cancer other than prostate cancer - defined as the presence of one inpatient or two outpatient claims with a primary or secondary diagnosis of malignant neoplasms (ICD-9-CM 140.xx-171.xx, 174.xx-184.xx,186.xx-195.xx,200.xx-209.3x, 230.xx-239.xx) - in the 12-month pre-index period.
- Subjects with any claim for a primary or secondary diagnosis indicating bone metastases (ICD-9-CM 198.5) or any treatment indicative of bone metastases in the 12-month pre-index period.
- Patients who had a SRE in the 12-month pre-index period.
- Subjects without continuous enrollment for at least 12 months before the index date.
- Subjects without continuous eligibility for at least 6 months after the index date.
- Subjects that are female.
- Subjects that have negative costs.
- Subjects that are less than 45 years of age on the index date.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Treatment patterns, healthcare resource utilization and costs
Part 1 - Assessment of treatment patterns, healthcare resource utilization and costs.
The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population.
The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
All patients must have no diagnosis of other cancers, no diagnosis of bone metastases or a claim for a treatment indicative of bone metastases, and no skeletal-related events (SREs) in the 12-month pre-index period.
Additionally, all subjects must be continuously enrolled for at least 12 months before and at least 6 months after the index date.
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Retrospective claims analysis.
Descriptive analyses of treatment patterns.
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Mortality
Part 2 - Assessment of mortality.
The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population.
The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
All patients must have no diagnosis of other cancers, no diagnosis of bone metastases or a claim for a treatment indicative of bone metastases, and no SREs in the 12-month pre-index period.
Additionally, all subjects must be continuously enrolled for at least 12 months before the index date.
Unlike in Part 1, there will be no required minimum follow-up time after the index date (in order to assess mortality).
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Retrospective claims analysis.
Descriptive analyses of treatment patterns.
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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 |
|---|---|---|
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Distribution of treatment types among lines of therapy
時間枠：Up to 6 months
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Possible Treatment Types: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy
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Up to 6 months
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Time to treatment (days)
時間枠：Up to 6 months
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Up to 6 months
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Duration of treatment (days)
時間枠：Up to 6 months
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Up to 6 months
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Number of patients on each drug or drug combination
時間枠：Up to 6 months
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Drug: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy
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Up to 6 months
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Number of inpatient visits per patient
時間枠：Upto 6 month post index period
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Upto 6 month post index period
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Length of hospital stay (days) among those with an inpatient visit
時間枠：Upto 6 month post index period
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Upto 6 month post index period
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Number of outpatient visits per patient
時間枠：Upto 6 month post index period
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Upto 6 month post index period
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Number of emergency room (ER) visits per patient
時間枠：Upto 6 month post index period
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Upto 6 month post index period
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Number of physician office visits per patient
時間枠：Upto 6 month post index period
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Upto 6 month post index period
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Number of medication prescriptions per patient
時間枠：Upto 6 month post index period
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Upto 6 month post index period
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Number of patients by provider type
時間枠：Upto 6 month post index period
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Upto 6 month post index period
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Number of claims per patient
時間枠：Upto 6 month post index period
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Upto 6 month post index period
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Total costs of healthcare
時間枠：Upto 6 month post index period
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Upto 6 month post index period
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Medical costs of healthcare
時間枠：Upto 6 month post index period
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Upto 6 month post index period
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Pharmacy costs of healthcare
時間枠：Upto 6 month post index period
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Upto 6 month post index period
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Per-patient-per-month (PPPM)) costs of healthcare
時間枠：Upto 6 month post index period
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Upto 6 month post index period
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Mortality rate
時間枠：Up to 6 months
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Up to 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Opioid/analgesic use among lines of therapy(Y/N)
時間枠：Up to 6 months
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Opioid and analgesics use among lines of therapy (e.g.
1st, 2nd, 3rd)
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Up to 6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年10月31日
一次修了 (実際)
2017年1月19日
研究の完了 (実際)
2017年1月19日
試験登録日
最初に提出
2016年3月16日
QC基準を満たした最初の提出物
2016年3月31日
最初の投稿 (見積もり)
2016年4月6日
学習記録の更新
投稿された最後の更新 (実際)
2018年1月25日
QC基準を満たした最後の更新が送信されました
2018年1月24日
最終確認日
2018年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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