Educational Problems
Conditions
Brief summary
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).
Detailed 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.
Interventions
OTHERClinical Trial Educational Video
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.
OTHERClinical Trial Fact Sheet
General Clinical Trial fact sheet with usual care information regarding Clinical Trials.
OTHERLow literacy booklet
A bilingual low-literacy booklet with educational content about clinical trials.
OTHERNavigator
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.
Sponsors
The University of Texas Health Science Center at San Antonio
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who show intention to participate or to consider CTs as an appropriate treatment option for cancer. | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who show increase in knowledge/awareness regarding CT participation. | 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. |
| Proportion of patients who show improved attitudes regarding CT participation. | 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. |
| Proportion of patients eligible for designated clinical trials who actually enroll in one of these trials. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmelie G Ramirez, DrPH, MPH
UT Health San Antonio
PRINCIPAL_INVESTIGATORPatricia Chalela, DrPH, MPH
UT Health San Antonio
Outcome results
None listed