Purpose

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).

Category

IRB Number
20180283HU
NCT Number
NCT03820687
Open to Enrollment
Yes
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Patricia Chalela
+1 (210) 562-6513
chalela@uthscsa.edu

Vivian Cortez
(210) 567-6528
cortezv1@uthscsa.edu

Anna Moreno
(210) 567-0836
morenoa3@uthscsa.edu

Principal Investigator
Amelie Ramirez

Patricia Chalela
+1 (210) 562-6513
chalela@uthscsa.edu

Vivian Cortez
(210) 567-6528
cortezv1@uthscsa.edu

Anna Moreno
(210) 567-0836
morenoa3@uthscsa.edu

Amelie Ramirez
(210) 562-6500
ramirezag@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    • Newly diagnosed cancer patients attending any of the clinics at the MCC
    • Patients who have not had a consultation with their doctor to discuss treatment options
    • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)
Condition
  • Educational Problems

    • Arm Groups

    ArmDescriptionIntervention
    Active Comparator

    Usual Care Control Group

    		Participants in the usual care control group will receive a general clinical trial fact sheet.
  • Other: Clinical Trial Fact Sheet

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

    • Active Comparator

    Intervention Group

    		Participants in the intervention group will receive 3 components: 1) a culturally tailored clinical trial educational video, 2) a brochure and 3) support from a patient navigator to empower new cancer patients to make informed decisions about cancer clinical trials 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 Video

    Culturally tailored educational video, brochure, and support from a patient navigator to empower new cancer patients to make informed decisions about cancer clinical trials.

  • Other: Brochure

    A brochure with educational material about clinical trials and services offered by Mays Cancer Center.

  • Other: Navigator

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

    •