Mobile Health (mHealth) Black Women With Breast Cancer

NCT ID: NCT02463474

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-12-31

Brief Summary

This research study will test whether a series of video clips with breast cancer information improves knowledge of breast cancer, breast cancer treatment and living with breast cancer. Questionnaires will be completed to learn if the videos are helpful and pleasant to watch.

Detailed Description

Though Black women have a lower breast cancer rate than White women, Black women have the poorest outcomes of all races and ethnicities. Low cancer knowledge and mistrust of the healthcare system have been shown to lead to poorer outcomes following breast cancer diagnosis. Participants are asked to be in this research study if they are a woman age 21 years or older who identifies as Black/ African American and has been diagnosed with breast cancer within the past 6 months.

First, participants will come to a pre-intervention study appointment and will be asked to complete several questionnaires. The questionnaires will ask about breast cancer knowledge, quality of life, and their relationship with their doctor. Participants will then opt-in to the study by sending a text message to the study.

For the next ten ten weeks, participants will receive a text message with a link to one video clip per week. Each video is 15-20 minutes long and contains information about breast cancer. Participants will also receive one supportive text message per week for ten weeks.

At the end of the ten weeks, participants will be scheduled for a follow-up appointment. Participants will again be asked questions about breast cancer knowledge, quality of life, and their relationship with their doctor. Participants will also be asked what was helpful and not helpful about the videos.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

mHealth Intervention

Each week for 10 weeks, participants will receive two text messages on their cell phone. The first text message will contain a link to a culturally tailored, informational video clip about living with breast cancer. The second text message that provides a supportive message about the video content.

Group Type: EXPERIMENTAL

mHealth Intervention

Intervention Type: BEHAVIORAL

Ten, short, engaging, entertaining and culturally relevant videos delivered to participants' cell phones provide breast cancer health information.

Interventions

mHealth Intervention

Ten, short, engaging, entertaining and culturally relevant videos delivered to participants' cell phones provide breast cancer health information.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age: 21 years or older
• Race/Ethnicity: Black from any cultural background (e.g., African American, Caribbean Islander, Haitian, Black Hispanic, etc.)
• Diagnosed with breast cancer stages 0-III in the past 6 months
• Life Expectancy: ≥12 months
• Income: at or below 200% of the federal poverty line
• Have access to a cellphone
• Able to receive text messages on cell phone
• Able to view video clips on cell phone.

Exclusion Criteria

• Previous diagnosis of any type of cancer
• Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to understand spoken English at the 8th grade level; unwilling to travel to University of Florida Health Shands hospital or HealthStreet for baseline and follow-up assessment appointments; inpatient psychiatric treatment for major psychiatric disorder in the past year; substance use disorder in the past year; and other conditions which in the opinion of study staff would adversely affect participation in the trial.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole Ennis Whitehead, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health Shands Hospital

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201401002

Identifier Type: -

Identifier Source: org_study_id