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.

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

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 Educational Video

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

Clinical Trial Fact Sheet

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

Low literacy booklet

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.

Navigator

Vivian Cortez, MS

Anna Moreno

Amelie G Ramirez, DrPH, MPH

Patricia Chalela, DrPH

Patricia Chalela, DrPH, MPH

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).

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.

Improving Informed Decision Making for Cancer Clinical Trial Participation

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Improving Informed Decision Making for Cancer Clinical Trial Participation	NCT03820687	Educational Pro...	Clinical Trial ... Clinical Trial ... Low literacy bo... Navigator	18 Years -	The University of Texas Health Science Center at San Antonio
Improving Informed Decision Making for Cancer Clinical Trial Participation	NCT03820687	Educational Pro...	Clinical Trial ... Clinical Trial ... Low literacy bo... Navigator	18 Years -	The University of Texas Health Science Center at San Antonio

Spots Global Cancer Trial Database for low literacy booklet