Clinical trial NCT02463474: Mobile Health (mHealth) Black Women With Breast Cancer
Official title: Piloting the Acceptability of a Culturally Tailored Evidence-Based mHealth Intervention for Low-Income Black Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 6
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Breast Cancer Knowledge
timeFrame: Baseline assessment (Week 1) to post-intervention assessment (Week 10)
Secondary outcomes:
measure: Perceived Involvement in Care Scale
timeFrame: Baseline assessment (Week 1) to post-intervention assessment (Week 10)
measure: Perceived Stress Scale
timeFrame: Baseline assessment (Week 1) to post-intervention assessment (Week 10)
measure: Functional Assessment of Cancer Therapy-Breast (FACT-B)
timeFrame: Baseline assessment (Week 1) to post-intervention assessment (Week 10)
measure: Acceptability
timeFrame: Baseline assessment (Week 1) to post-intervention assessment (Week 10)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Shands Hospital
state: Florida
Study officials:
affiliation: University of Florida
name: Nicole Ennis Whitehead, PhD
role: PRINCIPAL_INVESTIGATOR
References: