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.
Přehled studie
Postavení
Detailní popis
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 studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Hiba M. Khan, MD
- Telefonní číslo: 206-606-2524
- E-mail: hibakhan@uw.edu
Studijní místa
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Washington
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Seattle, Washington, Spojené státy, 98109
- Fred Hutch/University of Washington Cancer Consortium
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Kontakt:
- Hiba M. Khan, MD
- Telefonní číslo: 206-606-2524
- E-mail: hibakhan@uw.edu
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Vrchní vyšetřovatel:
- Hiba M. Khan, MD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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
Ostatní jména:
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Experimentální: 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
Ostatní jména:
Attend appointment with GU medical oncologist
Ostatní jména:
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Experimentální: 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
Ostatní jména:
Attend appointment with GU medical oncologist
Ostatní jména:
Undergo re-screening
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of patients who "agree" or "completely agree" in the Feasibility of Intervention Measure (Feasibility)
Časové okno: After pre-screening for clinical trials is complete (Up to 9 months)
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After pre-screening for clinical trials is complete (Up to 9 months)
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Percentage of community providers who "agree" or "completely agree" in the Feasibility of Intervention Measure (Feasibility)
Časové okno: After enrollment is complete at the end of study period (Up to 24 months)
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After enrollment is complete at the end of study period (Up to 24 months)
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Percentage of patients who "agree" or "completely agree" in the Acceptability of Intervention Measure (Acceptability)
Časové okno: After pre-screening for clinical trials is complete (Up to 9 months)
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After pre-screening for clinical trials is complete (Up to 9 months)
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Percentage of community providers who "agree" or "completely agree" in the Acceptability of Intervention Measure (Acceptability)
Časové okno: After enrollment is complete at the end of study period (Up to 24 months)
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After enrollment is complete at the end of study period (Up to 24 months)
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Percentage of patients who "agree" or "completely agree" in the Intervention Appropriateness Measure (Appropriateness)
Časové okno: After pre-screening for clinical trials is complete (Up to 9 months)
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After pre-screening for clinical trials is complete (Up to 9 months)
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Percentage of community providers who "agree" or "completely agree" in the Intervention Appropriateness Measure (Appropriateness)
Časové okno: After enrollment is complete at the end of study period (Up to 24 months)
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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
Časové okno: Up to 9 months
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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
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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
Časové okno: Up to 9 months
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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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Perceived barriers to participation in clinical trials
Časové okno: Baseline up to 9 months
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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
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Distribution of participants by race and ethnicity among remotely pre-screened patients who enroll or indicate intent to enroll in a clinical trial
Časové okno: Up to 9 months
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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
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Hiba M. Khan, MD, Fred Hutch/University of Washington Cancer Consortium
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Onemocnění genitálií
- Genitální novotvary, muži
- Urogenitální novotvary
- Novotvary podle místa
- Novotvary
- Onemocnění pohlavních orgánů, muž
- Onemocnění prostaty
- Mužská urogenitální onemocnění
- Urologická onemocnění
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Urologické novotvary
- Onemocnění močového měchýře
- Novotvary prostaty
- Novotvary močového měchýře
- Správa zdravotnických služeb
- Řízení péče o pacienty
- Komplexní zdravotní péče
- Péče zaměřená na pacienta
- Primární zdravotní péče
- Navigace pacienta
Další identifikační čísla studie
- RG1126822
- P30CA015704 (Grant/smlouva NIH USA)
- NCI-2026-07173 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
- STUDY00025270 (Jiný identifikátor: Fred Hutch/University of Washington Cancer Consortium)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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