NCT03820687

Brief Summary

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
581

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Feb 2023Dec 2026

First Submitted

Initial submission to the registry

January 3, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
4 years until next milestone

Study Start

First participant enrolled

February 8, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

January 3, 2019

Last Update Submit

March 11, 2026

Conditions

Educational Problems

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who show intention to participate or to consider CTs as an appropriate treatment option for cancer.

    The percentage of patients who increased intentions to participate in a CT after the intervention compared with baseline.

    Up to 3 months after the index oncology visit

Secondary Outcomes (3)

  • Proportion of patients who show increase in knowledge/awareness regarding CT participation.

    Up to 3 months after the index oncology visit

  • Proportion of patients who show improved attitudes regarding CT participation.

    Up to 3 months after the index oncology visit

  • Proportion of patients eligible for designated clinical trials who actually enroll in one of these trials.

    Up to 3 months after the index oncology visit

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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.

Other: Clinical Trial Educational VideoOther: Low literacy bookletOther: Navigator

Usual Care Control Group

ACTIVE COMPARATOR

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

Other: Clinical Trial Fact Sheet

Interventions

Clinical Trial Educational VideoOTHER

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 Group
Clinical Trial Fact SheetOTHER

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

Usual Care Control Group
Low literacy bookletOTHER

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

Intervention Group
NavigatorOTHER

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 Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center San Antonio, MCC

San Antonio, Texas, 78229, United States

Location

Study Officials

  • Amelie G Ramirez, DrPH, MPH

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

  • Patricia Chalela, DrPH, MPH

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 29, 2019

Study Start

February 8, 2023

Primary Completion

October 31, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations

US(1)