Breast NeoplasmsNCT02463474
Mobile Health (mHealth) Black Women With Breast Cancer
A study testing mHealth Intervention in people with Breast Neoplasms, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- mHealth Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Shands Hospital
Gainesville, Florida, 32610
About this study
Official title: Piloting the Acceptability of a Culturally Tailored Evidence-Based mHealth Intervention for Low-Income Black Women With Breast Cancer
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.
Read the 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
- Being tested
- mHealth Intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth InterventionBehavioural
Ten, short, engaging, entertaining and culturally relevant videos delivered to participants' cell phones provide breast cancer health information.
| Study group | Role | What they receive |
|---|---|---|
| mHealth Intervention | Experimental | 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. Receives: Behavioral: mHealth Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline assessment (Week 1) to post-intervention assessment (Week 10)
Secondary outcomes (4)
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.
Measured: Baseline assessment (Week 1) to post-intervention assessment (Week 10)
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.
Measured: Baseline assessment (Week 1) to post-intervention assessment (Week 10)
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.
Measured: Baseline assessment (Week 1) to post-intervention assessment (Week 10)
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
Measured: Baseline assessment (Week 1) to post-intervention assessment (Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Ennis Whitehead, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463474
- Sponsor's protocol ID
- IRB201401002
- Status last verified
- Jan 2017
- First submitted
- 29 May 2015
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting the Acceptability of a Culturally Tailored Evidence-Based mHealth Intervention for Low-Income Black Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT02463474
- Acronym / sponsor ID
- IRB201401002
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mHealth Intervention | Experimental | Behavioral: mHealth InterventionEach 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth InterventionTen, short, engaging, entertaining and culturally relevant videos delivered to participants' cell phones provide breast cancer health information. | Behavioural | mHealth Intervention |
Primary outcome
Breast Cancer Knowledge
Time frame: Baseline assessment (Week 1) to post-intervention assessment (Week 10)
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.
4 secondary outcomes
Perceived Involvement in Care Scale
Time frame: Baseline assessment (Week 1) to post-intervention assessment (Week 10)
Perceived Stress Scale
Time frame: Baseline assessment (Week 1) to post-intervention assessment (Week 10)
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Time frame: Baseline assessment (Week 1) to post-intervention assessment (Week 10)
Acceptability
Time frame: Baseline assessment (Week 1) to post-intervention assessment (Week 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Ennis Whitehead, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Intervention in people with Breast Neoplasms, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Cancer Knowledge (time frame: Baseline assessment (Week 1) to post-intervention assessment (Week 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.