search
Back to results

Mobile Health (mHealth) Black Women With Breast Cancer

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth Intervention
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasms

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UF Health Shands Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mHealth Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Breast Cancer Knowledge
Breast cancer knowledge will be assessed using the Knowledge subscales of the Breast Cancer Surgery Decision Quality Instrument, short version 2 (BCS-DQI, SV2) developed by Massachusetts General Hospital. The knowledge subscale has twelve multiple choice or fill in the blank items about breast cancer, treatment options, recurrence, survival and side effects.

Secondary Outcome Measures

Perceived Involvement in Care Scale
The Perceived Involvement in Care Scale (PICS) is a 13 item self-report scale that assesses patient's perception of doctor and patient behaviors that occur during a medical visit. It assesses the patients' perception of the doctors' facilitation of patient involvement, amount of information exchanged between the patient and doctor, and patient involvement in decision making.
Perceived Stress Scale
The Perceived Stress Scale (PSS) is a 10-item, self-report questionnaire of globally perceived stress. Each item is rated for the past month on a 5-point Likert scale (1 = never to 5 = very often). A higher total score indicates greater stress.
Functional Assessment of Cancer Therapy-Breast (FACT-B)
This questionnaire is a global measure of quality of life. The FACT-B assesses well-being across five broad domains (i.e., physical, spiritual, social/family, emotional, and functional) and one specific domain of breast cancer symptoms. The instructions ask participants to indicate to what degree each statement has been "true" during the past seven days.
Acceptability
This questionnaire queries the participant's ratings of the acceptability of the program. Item content includes: program was a good use of my time, program was helpful, program will be useful in my daily life, program has helped me deal with my breast cancer, likeability of of the interventionist, acceptability of mobile health (mhealth) format, perceived skill of interventionist, ease of participation in intervention, interactions with program staff, ease of trouble shooting difficulties and overall rating

Full Information

First Posted
May 29, 2015
Last Updated
January 13, 2017
Sponsor
University of Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT02463474
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mHealth Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
mHealth Intervention
Intervention Description
Ten, short, engaging, entertaining and culturally relevant videos delivered to participants' cell phones provide breast cancer health information.
Primary Outcome Measure Information:
Title
Breast Cancer Knowledge
Description
Breast cancer knowledge will be assessed using the Knowledge subscales of the Breast Cancer Surgery Decision Quality Instrument, short version 2 (BCS-DQI, SV2) developed by Massachusetts General Hospital. The knowledge subscale has twelve multiple choice or fill in the blank items about breast cancer, treatment options, recurrence, survival and side effects.
Time Frame
Baseline assessment (Week 1) to post-intervention assessment (Week 10)
Secondary Outcome Measure Information:
Title
Perceived Involvement in Care Scale
Description
The Perceived Involvement in Care Scale (PICS) is a 13 item self-report scale that assesses patient's perception of doctor and patient behaviors that occur during a medical visit. It assesses the patients' perception of the doctors' facilitation of patient involvement, amount of information exchanged between the patient and doctor, and patient involvement in decision making.
Time Frame
Baseline assessment (Week 1) to post-intervention assessment (Week 10)
Title
Perceived Stress Scale
Description
The Perceived Stress Scale (PSS) is a 10-item, self-report questionnaire of globally perceived stress. Each item is rated for the past month on a 5-point Likert scale (1 = never to 5 = very often). A higher total score indicates greater stress.
Time Frame
Baseline assessment (Week 1) to post-intervention assessment (Week 10)
Title
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Description
This questionnaire is a global measure of quality of life. The FACT-B assesses well-being across five broad domains (i.e., physical, spiritual, social/family, emotional, and functional) and one specific domain of breast cancer symptoms. The instructions ask participants to indicate to what degree each statement has been "true" during the past seven days.
Time Frame
Baseline assessment (Week 1) to post-intervention assessment (Week 10)
Title
Acceptability
Description
This questionnaire queries the participant's ratings of the acceptability of the program. Item content includes: program was a good use of my time, program was helpful, program will be useful in my daily life, program has helped me deal with my breast cancer, likeability of of the interventionist, acceptability of mobile health (mhealth) format, perceived skill of interventionist, ease of participation in intervention, interactions with program staff, ease of trouble shooting difficulties and overall rating
Time Frame
Baseline assessment (Week 1) to post-intervention assessment (Week 10)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Ennis Whitehead, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Mobile Health (mHealth) Black Women With Breast Cancer

We'll reach out to this number within 24 hrs