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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Hiba M. Khan, MD
- Telefonnummer: 206-606-2524
- E-post: hibakhan@uw.edu
Studieorter
-
-
Washington
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Seattle, Washington, Förenta staterna, 98109
- Fred Hutch/University of Washington Cancer Consortium
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Kontakt:
- Hiba M. Khan, MD
- Telefonnummer: 206-606-2524
- E-post: hibakhan@uw.edu
-
Huvudutredare:
- Hiba M. Khan, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
Attend appointment with GU medical oncologist
Andra namn:
|
|
Experimentell: 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
Andra namn:
Attend appointment with GU medical oncologist
Andra namn:
Undergo re-screening
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of patients who "agree" or "completely agree" in the Feasibility of Intervention Measure (Feasibility)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Perceived barriers to participation in clinical trials
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Hiba M. Khan, MD, Fred Hutch/University of Washington Cancer Consortium
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Genitala neoplasmer, manliga
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Genitala sjukdomar, manliga
- Prostatasjukdomar
- Manliga urogenitala sjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Urologiska neoplasmer
- Sjukdomar i urinblåsan
- Prostatiska neoplasmer
- Neoplasmer i urinblåsan
- Administration
- Patientvårdshantering
- Omfattande vård
- Patientcentrerad vård
- Grundvård
- Patientnavigering
Andra studie-ID-nummer
- RG1126822
- P30CA015704 (U.S.S. NIH-anslag/kontrakt)
- NCI-2026-07173 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- STUDY00025270 (Annan identifierare: Fred Hutch/University of Washington Cancer Consortium)
Plan för individuella deltagardata (IPD)
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