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Behavioral Intervention

Patient Navigation for Cancer (GUIDE Trial)

N/A

Recruiting

Led By Jason Mendoza, MD, MPH

Research Sponsored by Fred Hutchinson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be ≥ 18 years of age

Be older than 18 years old

Must not have

Children, adolescents, and teens under the age of 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to increase participation and diversity in cancer clinical trials by using a program called GUIDE. GUIDE involves a trained navigator working with potential patients to help them overcome barriers like health-related social needs and financial

Who is the study for?

This trial is for cancer patients who may face social and financial barriers to participating in clinical trials. It aims to help those with breast, gastrointestinal, or bladder cancer by providing a 'Guide' to navigate the process.

What is being tested?

The study tests a patient navigation program called GUIDE that assigns a trained navigator to assist potential participants in overcoming obstacles to join cancer clinical trials, aiming for increased diversity and inclusion.

What are the potential side effects?

Since this trial involves non-medical intervention (patient navigation), there are no direct medical side effects associated with drugs or treatments. However, participation could impact time and require commitment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Financial burden

Health related quality of life

Participant perceptions of the intervention (acceptability, appropriateness, feasibility)

+5 more

Secondary study objectives

Amount of money provided to participants for reimbursement of trial-related expenses

Participant time costs

Staff time and effort to deliver intervention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ARM I (Clinical trial navigator, SOC)Experimental Treatment2 Interventions

Patients meet with a clinical trial navigator to understand activities involved with clinical trials, identify financial barriers to clinical trial participation, and review available financial resources. Patients receive ongoing access to the Guide via a check in meeting once monthly for up to 6 months. Patients also receive SOC supportive care services.

Group II: Arm II (SOC)Active Control1 Intervention

Patients receive SOC supportive care services.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patient Navigation

2017

Completed Phase 2

~38910

0 / 2Eligibility criteria met