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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bladder Carcinoma; Prostate Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Electronic Health Record Review; Other: Prescreen; Behavioral: Patient Navigation; Other: Rescreening

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hiba M. Khan, MD; Phone Number: 206-606-2524; Email: hibakhan@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Hiba M. Khan, MD; Phone Number: 206-606-2524; Email: hibakhan@uw.edu
      • Principal Investigator: Hiba M. Khan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Survey Administration; Ancillary studies; Other: Electronic Health Record Review; Undergo medical record review; Other: Prescreen; Undergo clinical trial eligibility pre-screening; Other Names: Prescreened; Prescreening
Experimental: 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.	Other: Survey Administration; Ancillary studies; Other: Electronic Health Record Review; Undergo medical record review; Other: Prescreen; Undergo clinical trial eligibility pre-screening; Other Names: Prescreened; Prescreening; Behavioral: Patient Navigation; Attend appointment with GU medical oncologist; Other Names: Patient Navigator Program
Experimental: 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.	Other: Survey Administration; Ancillary studies; Other: Electronic Health Record Review; Undergo medical record review; Other: Prescreen; Undergo clinical trial eligibility pre-screening; Other Names: Prescreened; Prescreening; Behavioral: Patient Navigation; Attend appointment with GU medical oncologist; Other Names: Patient Navigator Program; Other: Rescreening; Undergo re-screening; Other Names: Re-screening; Rescreen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients who "agree" or "completely agree" in the Feasibility of Intervention Measure (Feasibility)		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)		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)		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)		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)		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)		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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived barriers to participation in clinical trials	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	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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Hiba M. Khan, MD, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: October 26, 2026
• First Submitted That Met QC Criteria: October 26, 2026
• First Posted (Actual): November 2, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 4, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Prostatic Neoplasms; Urinary Bladder Neoplasms; Health Services Administration; Patient Care Management; Comprehensive Health Care; Patient-Centered Care; Primary Health Care; Patient Navigation
• Other Study ID Numbers: RG1126822; P30CA015704 (U.S. NIH Grant/Contract); NCI-2026-07173 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); STUDY00025270 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No