Clinical trial NCT03820687: Improving Informed Decision Making for Cancer Clinical Trial Participation
Official title: Improving Informed Decision Making for Cancer Clinical Trial Participation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Educational Problems
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2019-01-29
Enrollment: 581
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who show intention to participate or to consider CTs as an appropriate treatment option for cancer.
timeFrame: Up to 3 months after the index oncology visit
Secondary outcomes:
measure: Proportion of patients who show increase in knowledge/awareness regarding CT participation.
timeFrame: Up to 3 months after the index oncology visit
measure: Proportion of patients who show improved attitudes regarding CT participation.
timeFrame: Up to 3 months after the index oncology visit
measure: Proportion of patients eligible for designated clinical trials who actually enroll in one of these trials.
timeFrame: Up to 3 months after the index oncology visit
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio, MCC
state: Texas
Study officials:
affiliation: UT Health San Antonio
name: Amelie G Ramirez, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Health San Antonio
name: Patricia Chalela, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
References: