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CV CARE: PC 患者の心血管ケア

2026年9月18日 更新者：Alicia Morgans、Dana-Farber Cancer Institute

CV CARE: 前立腺がん患者におけるアンドロゲン関連影響の心血管ケア

This research is being done to test a program to assess and manage reversible cardiovascular (CV) risk factors in participants with prostate cancer starting androgen deprivation therapy (ADT), with the goal of integrating a standardized method into Dana-Farber Cancer Institute clinics for all such participants.

The name of the intervention used in this research study is:

CV Care (cardiovascular risk assessment and management program)

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This research is being done to test a program to assess and manage reversible cardiovascular (CV) risk factors in participants with prostate cancer starting androgen deprivation therapy (ADT), with the goal of integrating a standardized method into Dana-Farber Cancer Institute clinics for all such participants.

Study procedures including screening for eligibility, treatment visits, questionnaires and surveys, and blood and urine tests.

Participation in this research study is expected to last about 6 months.

It is expected that about 60-150 people will take part in this study.

This study is supported by the National Comprehensive Cancer Network (NCCN) through grant funding provided by Pfizer Myovant.

研究の種類

介入

入学 (推定)

180

段階

  • 適用できない

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。

研究連絡先

研究場所

  • アメリカ
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02215
        • 募集
        • Dana-Farber Cancer Institute
        • コンタクト：
        • 主任研究者：
          • Alicia Morgans, MD, MPH
      • Boston、Massachusetts、アメリカ、02215
        • 募集
        • Brigham and Women's Hospital
        • コンタクト：
        • 主任研究者：
          • Alicia Morgans, MD, MPH

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

18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

説明

Inclusion Criteria:

  • Participants must have a histologic diagnosis of prostate adenocarcinoma. Participants with any stage of prostate cancer are eligible, as long as treatment with at least 24 weeks of ADT is recommended by their treating physician.
  • Participants must have been prescribed a plan for treatment with at least 24 weeks of ADT, and can have received up to 12 weeks of ADT therapy.
  • Participants must be willing to participate in two CV CARE visits at weeks 12 and 24 after ADT initiation.
  • Participants must be willing to have their follow up visits for ADT management at DFCI Longwood site.
  • Participants must be willing to undergo lab and blood pressure assessments, which can include local labs and home blood pressure checks if they wish to do virtual visits for follow up care.
  • Participants can have pre-existing CVD and/or CV risk factors, but this is not a requirement for inclusion.
  • Participants receiving combination treatment with an androgen receptor signaling inhibitory, some examples being (abiraterone acetate, enzalutamide, darolutamide, apalutamide, or bicalutamide), immunotherapy (pembrolizumab), or PARP inhibitor (olaparib, rucaparib) are eligible.
  • Age ≥18 years.
  • Life expectancy of greater than 6 months.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 24 weeks due to complicated comorbidities that necessitate close collaboration between the participant and their cardiologist.
  • Participants who have already been on ADT therapy for more than 12 weeks are ineligible due to their treatment cycle being incompatible with the quality improvement initiative's trial design. ADT therapy is defined as either a GnRH agonist or antagonist.
  • Participants receiving combination treatment with ADT and chemotherapy (docetaxel, cabazitaxel, carboplatin), radioligand therapy (radium-223, 177PSMA-lutetium-617), or treatment on a clinical trial are not eligible due to potential for more intensive symptom management that may be required for optimal support of their cancer-directed treatment.
  • Participants actively included in therapeutic clinical trials are not eligible due to their greater time constraints.

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

  • 主な目的：ヘルスサービス研究
  • 割り当て：非ランダム化
  • 介入モデル：順次割り当て
  • 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
実験的：CV Care Program

Study procedures will be conducted as follows:

  • Standard of care androgen deprivation therapy.
  • 4 week standard-of-care follow up visit in clinic with CV care education module completion.
  • 12-week standard-of-care prostate cancer care visit with oncologist.
  • 24-week standard-of-care post-ADT visit in clinic with CV Care module completion, surveys, and exit interview with clinical team members.
  • The CV Care program will be revised through participant feedback from assessments, surveys, focus groups, and exit-interviews. The revised CV Care Program will be used in the next cohort.
行動：CV Care Program

Comprised of two, in-clinic, counseling sessions with oncology nurse practitioner or physician assistant for education on cardiovascular disease (CVD) and cardiovascular risk factors as well as recommendations for management.
実験的：CV Care Program 2

Study procedures will be conducted as follows:

  • Standard of care androgen deprivation therapy.
  • 4 week standard-of-care follow up visit in clinic with CV care education module completion.
  • 12-week standard-of-care prostate cancer care visit with oncologist.
  • 24-week standard-of-care post-ADT visit in clinic with CV Care module completion, surveys, and exit interview with clinical team members.
  • Participant feedback from surveys, exit-interviews, and possibly focus groups will be collected.
行動：CV Care Program

Comprised of two, in-clinic, counseling sessions with oncology nurse practitioner or physician assistant for education on cardiovascular disease (CVD) and cardiovascular risk factors as well as recommendations for management.

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
Participant Retention Rate in CV CARE 2
時間枠：Weeks 4 and 24 in CV CARE 2

The percentage of a continued participation rate at week 24 of participants who participate at week 4 in the revised iteration of the program (CV CARE 2).
Weeks 4 and 24 in CV CARE 2

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of Participants on Statin Medications in CV CARE
時間枠：5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

The percentage of participants who initiate or adjust statin medication usage during the period between 4 weeks after ADT initiation and the week 24 on-treatment visit among individuals with ASCVD risk scores exceeding 10% and 20% at week 4 of the study.
5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
Proportion of Participants on Statin Medications in CV CARE 2
時間枠：5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

The percentage of participants who initiate or adjust statin medication usage during the period between 4 weeks after ADT initiation and the week 24 on-treatment visit among individuals with ASCVD risk scores exceeding 10% and 20% at week 4 of the study.
5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
Proportion of Participants on Blood Pressure Medications in CV CARE
時間枠：5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

The percentage of participants who initiate or adjust blood pressure medication usage during the period between 4 weeks after ADT initiation and the week 24 on-treatment visit among individuals with ASCVD risk scores exceeding 10% and 20% at week 4 of the study.
5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
Proportion of Participants on Blood Pressure Medications in CV CARE 2
時間枠：5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

The percentage of participants who initiate or adjust blood pressure medication usage during the period between 4 weeks after ADT initiation and the week 24 on-treatment visit among individuals with ASCVD risk scores exceeding 10% and 20% at week 4 of the study.
5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
Proportion of Participants with Blood Pressure Below 130/85 (mmHg) in CV CARE
時間枠：6 months (From the ADT initiation to the week 24 on-treatment visit)

The comparison of proportion of participants with a blood pressure below 130/85 mmHg between the average blood pressure levels of weeks 12 and 24 of the program and the average blood pressure levels of ADT initiation and week 4.
6 months (From the ADT initiation to the week 24 on-treatment visit)
Proportion of Participants with Blood Pressure Below 130/85 (mmHg) in CV CARE 2
時間枠：6 months (From the ADT initiation to the week 24 on-treatment visit)

The comparison of proportion of participants with a blood pressure below 130/85 mmHg between the average blood pressure levels of weeks 12 and 24 of the program and the average blood pressure levels of ADT initiation and week 4.
6 months (From the ADT initiation to the week 24 on-treatment visit)

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

Dana-Farber Cancer Institute

協力者

National Comprehensive Cancer Network

捜査官

  • 主任研究者：Alicia Morgans, MD, MPH、Dana-Farber Cancer Institute

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)

2024年1月18日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2027年6月30日

試験登録日

最初に提出

2024年1月1日

QC基準を満たした最初の提出物

2024年1月1日

最初の投稿 (実際)

2024年1月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月22日

QC基準を満たした最後の更新が送信されました

2026年9月18日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 23-311

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD 共有時間枠

Data can be shared no earlier than 1 year following the date of publication

IPD 共有アクセス基準

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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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