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Remote Screening and Navigation to Increase Trial Enrollment, INVITE Trial (INVITE)

4 listopada 2026 zaktualizowane przez: Fred Hutchinson Cancer Center

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

50

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Hiba M. Khan, MD
  • Numer telefonu: 206-606-2524
  • E-mail: hibakhan@uw.edu

Lokalizacje studiów

  • Stany Zjednoczone
    • Washington
      • Seattle, Washington, Stany Zjednoczone, 98109
        • Fred Hutch/University of Washington Cancer Consortium
        • Kontakt:
        • Główny śledczy:
          • Hiba M. Khan, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Age ≥ 18

  • Ability to understand English or Spanish

  • Records must be available to review on Epic CareEverywhere

  • 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

  • Receiving care for prostate or bladder cancer at participating community sites

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3

  • Not enrolled in hospice

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: Survey Administration

Ancillary studies

Inny: Electronic Health Record Review

Undergo medical record review

Inny: Prescreen

Undergo clinical trial eligibility pre-screening

Inne nazwy:
  • Prescreened
  • Prescreening
Eksperymentalny: 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.
Inny: Survey Administration

Ancillary studies

Inny: Electronic Health Record Review

Undergo medical record review

Inny: Prescreen

Undergo clinical trial eligibility pre-screening

Inne nazwy:
  • Prescreened
  • Prescreening
Behawioralne: Patient Navigation

Attend appointment with GU medical oncologist

Inne nazwy:
  • Program Patient Navigator
Eksperymentalny: 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.
Inny: Survey Administration

Ancillary studies

Inny: Electronic Health Record Review

Undergo medical record review

Inny: Prescreen

Undergo clinical trial eligibility pre-screening

Inne nazwy:
  • Prescreened
  • Prescreening
Behawioralne: Patient Navigation

Attend appointment with GU medical oncologist

Inne nazwy:
  • Program Patient Navigator
Inny: Rescreening

Undergo re-screening

Inne nazwy:
  • Re-screening
  • Rescreen

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of patients who "agree" or "completely agree" in the Feasibility of Intervention Measure (Feasibility)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Perceived barriers to participation in clinical trials
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Fred Hutchinson Cancer Center

Współpracownicy

National Cancer Institute (NCI)

Śledczy

  • Główny śledczy: Hiba M. Khan, MD, Fred Hutch/University of Washington Cancer Consortium

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 stycznia 2027

Zakończenie podstawowe (Szacowany)

31 marca 2027

Ukończenie studiów (Szacowany)

31 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

26 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 października 2026

Pierwszy wysłany (Rzeczywisty)

2 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 listopada 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • RG1126822
  • P30CA015704 (Grant/umowa NIH USA)
  • NCI-2026-07173 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
  • STUDY00025270 (Inny identyfikator: Fred Hutch/University of Washington Cancer Consortium)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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