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Improving Informed Decision Making for Cancer Clinical Trial Participation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820687
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
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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).

Condition or disease Intervention/treatment Phase
Educational Problems Other: Clinical Trial Educational Video Other: Clinical Trial Fact Sheet Other: Brochure Other: Navigator Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Improving Informed Decision Making for Cancer Clinical Trial Participation
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2023
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients who show intention to participate or to consider CTs as an appropriate treatment option for cancer. [ Time Frame: 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 Outcome Measures :
  1. Proportion of patients who show increase in knowledge/awareness regarding CT participation. [ Time Frame: 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.

  2. Proportion of patients who show improved attitudes regarding CT participation. [ Time Frame: 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.

  3. Proportion of patients eligible for designated clinical trials who actually enroll in one of these trials. [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820687


Contacts
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Contact: Sneha Prabhu, MPH 210-562-6546 prabhus@uthscsa.edu
Contact: Jessica Gutierrez 210-562-6505 gutierrezj4@uthscsa.edu

Locations
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United States, Texas
University of Texas Health Science Center San Antonio, MCC
San Antonio, Texas, United States, 78229
Contact: Amelie G Ramirez, DrPH, MPH    210-562-6500    ramirezag@uthscsa.edu   
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Amelie G Ramirez, DrPH, MPH UT Health San Antonio
Principal Investigator: Patricia Chalela, DrPH, MPH UT Health San Antonio
More Information
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03820687    
Other Study ID Numbers: HSC20180283H
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No