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NCT Number: NCT03820687

Improving Informed Decision Making for Cancer Clinical Trial Participation

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Educational Problems

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center San Antonio, MCC

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical Trial Educational Video

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.

Clinical Trial Fact Sheet

Other

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

Low literacy booklet

Other

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

navigator

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.

Primary outcomes

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

    Time frame: Up to 3 months after the index oncology visit

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

Secondary outcomes

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

    Time frame: Up to 3 months after the index oncology visit

    The percentage of patients who improved knowledge/awareness about clinical trials after the intervention compared with baseline.

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

    Time frame: Up to 3 months after the index oncology visit

    The percentage of patients who improve their attitudes towards clinical trial participation after the intervention compared with baseline.

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

    Time frame: Up to 3 months after the index oncology visit

    The percentage of patients who actually participate, or enroll in a clinical trial if they meet the eligibility criteria.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Genentech, Inc.

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jan 29, 2019
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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