Clinical trial NCT02808598: Breast Cancer Trials Education Program
Official title: Scientific Literacy and Breast Cancer Clinical Trials Education Program for Hispanic American and African American Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Clinical Trials
Education
Hispanic Americans
African Americans
Health Disparities
Patient Participation
Refusal to Participate
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Diego State University
name: Vista Community Clinic
First posted: 2016-06-22
Enrollment: 1065
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to test a program designed to increase African American and Hispanic American women's scientific literacy, knowledge of clinical trials, and to facilitate breast cancer clinical trial participation.

Detailed description: Knowledge and participation in clinical trials is disproportionately low among minorities. The purpose of this study is to test a program designed to increase African American and Hispanic American women's scientific literacy, knowledge of clinical trials, and to facilitate breast cancer clinical trial participation.

A validation study was also conducted to validate several measures for the Hispanic American and African American populations.

The experimental group watched an education program concerning breast cancer clinical trials while the control group watched an education program on neighborhood safety.

To examine willingness to participate in research was assessed by a post-intervention invitation to complete a sleep diary.

Eligibility criteria: Inclusion Criteria:

* Self-Identified as an African American or a Hispanic American female
* Speak English and/or Spanish
* Mentally and Physically capable of completing the consenting process

Exclusion Criteria:

* None

Primary outcomes:
measure: Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Personal Health Survey.
timeFrame: Baseline data using Personal Health Survey were collected immediately prior to participants' randomization to either the experimental or control study arms.
measure: Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Social Status Survey.
timeFrame: Baseline data using Social Status Survey were collected immediately prior to participants' randomization to either the experimental or control study arms.
measure: Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Reactions to Race Module.
timeFrame: Baseline data using Reactions to Race Module were collected immediately prior to participants' randomization to either the experimental or control study arms.
measure: Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Beliefs & Attitudes Survey.
timeFrame: Baseline data using Beliefs & Attitudes Survey were collected immediately prior to participants' randomization to either the experimental or control study arms.
measure: Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Duke University Religion Index.
timeFrame: Baseline data using Duke University Religion Index were collected immediately prior to participants' randomization to either the experimental or control study arms.
measure: Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Health-Related Quality of Life-4.
timeFrame: Baseline data using Health-Related Quality of Life-4 were collected immediately prior to participants' randomization to either the experimental or control study arms.
measure: Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Patient Health Questionnaire-9.
timeFrame: Baseline data using Patient Health Questionnaire-9 were collected immediately prior to participants' randomization to either the experimental or control study arms.
measure: Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Cancer Worry Scale.
timeFrame: Baseline data using Cancer Worry Scale were collected immediately prior to participants' randomization to either the experimental or control study arms.
measure: Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Powe Fatalism Inventory.
timeFrame: Baseline data using Powe Fatalism Inventory were collected immediately prior to participants' randomization to either the experimental or control study arms.
measure: Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Measure (Barriers to Clinical Trials Participation).
timeFrame: Baseline data using Barriers to Clinical Trials Participation were collected immediately prior to participants' randomization to either the experimental or control study arms and also immediately after the completion of the educational intervention.
measure: Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Clinical Trials Knowledge Questionnaire.
timeFrame: Baseline data using Clinical Trials Knowledge Questionnaire were collected immediately prior to participants' randomization to either the experimental or control study arms and also immediately after the completion of the educational intervention.
measure: Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Neighborhood Watch Knowledge Questionnaire.
timeFrame: Baseline data using Neighborhood Watch Knowledge Questionnaire were collected immediately prior to participants' randomization to either the experimental or control study arms and also immediately after the completion of the educational intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Vista
country: United States
facility: Vista Community Clinic
state: California
Study officials:
affiliation: UC San Diego Moores Cancer Center
name: Georgia R Sadler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Vanessa L Malcarne, PhD
role: PRINCIPAL_INVESTIGATOR
References: