Improving Informed Decision Making for Cancer Clinical Trial Participation

The University of Texas System (UT)

Status

Active, not recruiting

Conditions

Educational Problems

Treatments

Other: Clinical Trial Educational Video

Other: Navigator

Other: Clinical Trial Fact Sheet

Other: Low literacy booklet

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03820687

HSC20180283H

Details and patient eligibility

About

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).

Full description

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.

Enrollment

581 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

581 participants in 2 patient groups

Intervention Group

Active Comparator group

Description:

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.

Treatment: