Improving Informed Decision Making for Cancer Clinical Trial Participation

NCT ID: NCT03820687

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

581 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-08

Study Completion Date

2026-12-31

Brief Summary

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The goal of this study is to develop and pilot test a multi-communication approach to improve informed decision-making about cancer Clinical Trials (CTs) participation by increasing awareness of CTs and Mays Cancer Center (MCC) services (treatment care capacities, reputation and resources), positive attitudes towards CTs, self-efficacy and intentions to consider CTs as an appropriate treatment option for cancer (intention to participate) among patients attending the MCC (clinic-based setting) and the general public in selected Bexar County areas (community-based settings).

Detailed Description

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The proposed two-year study involves a randomized controlled educational trial featuring a 2-group parallel cohort design with random assignment of 400 cancer patients from the MCC to the intervention or usual care control group. Intervention participants will receive 3 components: 1) a bilingual culturally relevant educational video, 2) a low-literacy booklet and 3) support from a patient navigator to empower new cancer patients to make informed decisions about cancer CT participation by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider CTs as an appropriate treatment option for cancer. The usual care control group will receive a general CT fact sheet.

The community setting will involve a community awareness campaign including 400 community members, with 3 components: 1) an educational session delivered via PowerPoint presentation or flip chart, 2) a low-literacy booklet, and 3) support from a community health educator to raise awareness, positive attitudes and intentions to consider CTs as an appropriate treatment option for cancer and promote the MCC services among community members in Bexar County.

Conditions

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Educational Problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention Group

Participants in the intervention group will receive 3 components: 1) a bilingual, culturally tailored clinical trial educational video, 2) a low literacy booklet, and 3) support from a patient navigator to empower cancer patients to make informed decisions about cancer clinical trial participation by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider clinical trials as an appropriate treatment option for cancer.

Group Type ACTIVE_COMPARATOR

Clinical Trial Educational Video

Intervention Type OTHER

Bilingual, culturally tailored educational video, low literacy booklet, and support from a patient navigator to empower new cancer patients to make informed decisions about cancer clinical trial participation.

Low literacy booklet

Intervention Type OTHER

A bilingual low-literacy booklet with educational content about clinical trials.

Navigator

Intervention Type OTHER

Support will be provided by a patient navigator to empower cancer patients to make an informed decision about cancer clinical trial participation by increasing awareness of clinical trials and MCC services, positive attitudes, and intentions to consider clinical trials as an appropriate treatment option for cancer.

Usual Care Control Group

Participants in the usual care control group will receive a general clinical trial fact sheet.

Group Type ACTIVE_COMPARATOR

Clinical Trial Fact Sheet

Intervention Type OTHER

General Clinical Trial fact sheet with usual care information regarding Clinical Trials.

Interventions

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Clinical Trial Educational Video

Bilingual, culturally tailored educational video, low literacy booklet, and support from a patient navigator to empower new cancer patients to make informed decisions about cancer clinical trial participation.

Intervention Type OTHER

Clinical Trial Fact Sheet

General Clinical Trial fact sheet with usual care information regarding Clinical Trials.

Intervention Type OTHER

Low literacy booklet

A bilingual low-literacy booklet with educational content about clinical trials.

Intervention Type OTHER

Navigator

Support will be provided by a patient navigator to empower cancer patients to make an informed decision about cancer clinical trial participation by increasing awareness of clinical trials and MCC services, positive attitudes, and intentions to consider clinical trials as an appropriate treatment option for cancer.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed cancer patients (within 1 year) attending any of the clinics at the MCC
* Patients who have not participated in a Clinical Trial before
* English or Spanish-speaking
* Able to provide informed consent

Exclusion Criteria

* Younger than 18 years
* Patients who have already had a consultation with their doctor to discuss treatment options
* Patients who have participated in a Clinical Trial before
* Unable to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Patricia Chalela

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amelie G Ramirez, DrPH, MPH

Role: PRINCIPAL_INVESTIGATOR

UT Health San Antonio

Patricia Chalela, DrPH, MPH

Role: PRINCIPAL_INVESTIGATOR

UT Health San Antonio

Locations

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University of Texas Health Science Center San Antonio, MCC

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC20180283H

Identifier Type: -

Identifier Source: org_study_id

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