Remote Screening and Navigation to Increase Trial Enrollment, INVITE Trial (INVITE)
INVITE: Remote ScreenIng & NaVigation to Increase Trial Enrollment
This clinical trial studies the feasibility, acceptability, appropriateness, and effectiveness of a remote screening and navigation program in increasing clinical trial enrollment among patients with prostate and bladder cancer receiving cancer care in the community setting. Genitourinary (GU) cancers, including prostate and bladder cancer, are among the most common affecting patients in the United States. In spite of recent advances, there are still only a few broad categories of treatments effective in both prostate and bladder cancer, and investigating new therapies in clinical trials is essential. In Washington State, the majority of patients with prostate and bladder cancer are treated at local community oncology sites. Patients are referred to Fred Hutch (FH) GU oncologists for clinical trials, but often this referral occurs once a patient has exhausted all standard of care options for treatment. This remote screening and navigation study involves approaching patients at community oncology and urology clinics in the Washington State area and pre-screening them for eligibility in open clinical trials at FH. Interested eligible patients will then be referred to our patient navigation program to be seen by a GU medical oncologist at Fred Hutch Cancer Center. This program may help increase access to clinical trials for patients with prostate and bladder cancer, as well as strengthen collaboration between community oncology providers and GU oncology specialists at FH.
調査の概要
状態
詳細な説明
OUTLINE:
Patients have their medical records reviewed by the research nursing team and are pre-screened for open clinical trials at Fred Hutch Cancer Center. Patients NOT eligible for a clinical trial are assigned to Group I. Patients who are immediately eligible for a clinical trial are assigned to Group II. Patients who are eligible for a clinical trial in the future upon disease progression or change in status are assigned to Group III.
GROUP I: Patients are notified and receive no further contact.
GROUP II: Patients who are interested in learning more about the clinical trial(s) are contacted and scheduled for an appointment with a GU medical oncologist to discuss further. Patients who are NOT interested receive no further contact. These patients may have the option for future pre-screening.
GROUP III: Patients who are interested in learning more about the clinical trial(s) are contacted and scheduled for an appointment with a GU medical oncologist to discuss further. Patients who are interested in pursuing the clinical trial(s) upon eligibility, but do not wish to proceed to a GU appointment have the option to reach out at time of eligibility for re-screening and appointment. Patients who are NOT interested in the clinical trial(s) they are eligible for and/or not interested in participation receive no further contact. These patients may have the option for future pre-screening.
After completion of study, patients are followed for 12 months.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Hiba M. Khan, MD
- 電話番号：206-606-2524
- メール：hibakhan@uw.edu
研究場所
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Washington
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Seattle、Washington、アメリカ、98109
- Fred Hutch/University of Washington Cancer Consortium
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コンタクト：
- Hiba M. Khan, MD
- 電話番号：206-606-2524
- メール：hibakhan@uw.edu
-
主任研究者：
- Hiba M. Khan, MD
-
-
参加基準
適格基準
就学可能な年齢
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:
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Age ≥ 18
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Ability to understand English or Spanish
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Records must be available to review on Epic CareEverywhere
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Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives (LAR) may sign and give informed consent on behalf of study participants
- For participants utilizing LAR, participant must assent or otherwise be capable of completing patient-reported surveys
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Receiving care for prostate or bladder cancer at participating community sites
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Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
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Not enrolled in hospice
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：ヘルスサービス研究
- 割り当て：非ランダム化
- 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 |
|---|---|
|
実験的：Group I (pre-screening)
Patients have their medical records reviewed by the research nursing team and are pre-screened for open clinical trials at Fred Hutch Cancer Center for 9 months. Patients NOT eligible for a clinical trial are notified and receive no further contact. |
Ancillary studies Undergo medical record review Undergo clinical trial eligibility pre-screening
他の名前：
|
|
実験的：Group II (pre-screening, GU appointment)
Patients have their medical records reviewed by the research nursing team and are pre-screened for open clinical trials at Fred Hutch Cancer Center for 9 months. Patients who are immediately eligible for a clinical trial who are interested in learning more about the clinical trial(s) are contacted and scheduled for an appointment with a GU medical oncologist to discuss further. Patients who are immediately eligible for a clinical trial who are NOT interested receive no further contact. These patients may have the option for future pre-screening. |
Ancillary studies Undergo medical record review Undergo clinical trial eligibility pre-screening
他の名前：
Attend appointment with GU medical oncologist
他の名前：
|
|
実験的：Group III (pre-screening, GU appointment, re-screening)
Patients have their medical records reviewed by the research nursing team and are pre-screened for open clinical trials at Fred Hutch Cancer Center for 9 months. Patients who are eligible for a clinical trial in the future upon disease progression or change in status who are interested in learning more about the clinical trial(s) are contacted and scheduled for an appointment with a GU medical oncologist to discuss further. Patients who are eligible for a clinical trial in the future upon disease progression or change in status who are interested in pursuing the clinical trial(s) upon eligibility, but do not wish to proceed to a GU appointment have the option to reach out at time of eligibility for re-screening and appointment. Patients who are eligible for a clinical trial in the future upon disease progression or change in status who are NOT interested in the clinical trial(s) they are eligible for and/or not interested in participation receive no further contact. |
Ancillary studies Undergo medical record review Undergo clinical trial eligibility pre-screening
他の名前：
Attend appointment with GU medical oncologist
他の名前：
Undergo re-screening
他の名前：
|
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 |
|---|---|---|
|
Percentage of patients who "agree" or "completely agree" in the Feasibility of Intervention Measure (Feasibility)
時間枠：After pre-screening for clinical trials is complete (Up to 9 months)
|
After pre-screening for clinical trials is complete (Up to 9 months)
|
|
|
Percentage of community providers who "agree" or "completely agree" in the Feasibility of Intervention Measure (Feasibility)
時間枠：After enrollment is complete at the end of study period (Up to 24 months)
|
After enrollment is complete at the end of study period (Up to 24 months)
|
|
|
Percentage of patients who "agree" or "completely agree" in the Acceptability of Intervention Measure (Acceptability)
時間枠：After pre-screening for clinical trials is complete (Up to 9 months)
|
After pre-screening for clinical trials is complete (Up to 9 months)
|
|
|
Percentage of community providers who "agree" or "completely agree" in the Acceptability of Intervention Measure (Acceptability)
時間枠：After enrollment is complete at the end of study period (Up to 24 months)
|
After enrollment is complete at the end of study period (Up to 24 months)
|
|
|
Percentage of patients who "agree" or "completely agree" in the Intervention Appropriateness Measure (Appropriateness)
時間枠：After pre-screening for clinical trials is complete (Up to 9 months)
|
After pre-screening for clinical trials is complete (Up to 9 months)
|
|
|
Percentage of community providers who "agree" or "completely agree" in the Intervention Appropriateness Measure (Appropriateness)
時間枠：After enrollment is complete at the end of study period (Up to 24 months)
|
After enrollment is complete at the end of study period (Up to 24 months)
|
|
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Percentage of remotely screened patients that are identified as eligible for a prostate or bladder cancer clinical trial at Fred Hutch (FH) and enroll in that clinical trial
時間枠：Up to 9 months
|
Analysis of these percentages will be taken into context with the reported barriers that our patient population describes. Will provide rationale for a larger clinical trial, in which barriers can be directly addressed if possible, to assess improvement in clinical trial interest/participation among patients receiving care in the community. |
Up to 9 months
|
|
Percentage of remotely screened patients that are identified as eligible or potentially eligible for a prostate or bladder cancer clinical trial at FH, and express interest in participating
時間枠：Up to 9 months
|
Analysis of these percentages will be taken into context with the reported barriers that our patient population describes. Will provide rationale for a larger clinical trial, in which barriers can be directly addressed if possible, to assess improvement in clinical trial interest/participation among patients receiving care in the community. |
Up to 9 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Perceived barriers to participation in clinical trials
時間枠：Baseline up to 9 months
|
Free-text survey data from patients and qualitative interview data from referring providers will be analyzed using Braun & Clarke's inductive thematic analysis framework. |
Baseline up to 9 months
|
|
Distribution of participants by race and ethnicity among remotely pre-screened patients who enroll or indicate intent to enroll in a clinical trial
時間枠：Up to 9 months
|
Free-text survey data from patients and qualitative interview data from referring providers will be analyzed using Braun & Clarke's inductive thematic analysis framework. |
Up to 9 months
|
協力者と研究者
捜査官
- 主任研究者：Hiba M. Khan, MD、Fred Hutch/University of Washington Cancer Consortium
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RG1126822
- P30CA015704 (米国 NIH グラント/契約)
- NCI-2026-07173 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- STUDY00025270 (その他の識別子：Fred Hutch/University of Washington Cancer Consortium)
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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