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).

Condition

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)

Arm Groups

ArmDescriptionAssigned Intervention
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.
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.

More Details

Status
Not yet recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Sneha Prabhu, MPH
210-562-6546
prabhus@uthscsa.edu

Detailed Description

The proposed two-year study involves a randomized controlled educational trial featuring a 2-group 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 culturally relevant educational video, 2) a brochure and 3) support from a patient navigator to empower new cancer patients to make informed decisions about cancer CTs 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 education module will have also 3 components: 1) an educational session delivered via PowerPoint presentation or flip chart, 2) a brochure, and 3) support from a community health educator to raise awareness, positive attitudes and intentions to consider CTs as an appropriate treatment for cancer and promote the MCC services among community members in Bexar County.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.