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Completed

NCT Number: NCT02463474

Mobile Health (mHealth) 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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UF Health Shands Hospital

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mHealth Intervention

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Perceived Involvement in Care Scale

    Time frame: Baseline assessment (Week 1) to post-intervention assessment (Week 10)

    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.

  2. Perceived Stress Scale

    Time frame: Baseline assessment (Week 1) to post-intervention assessment (Week 10)

    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.

  3. Functional Assessment of Cancer Therapy-Breast (FACT-B)

    Time frame: Baseline assessment (Week 1) to post-intervention assessment (Week 10)

    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.

  4. Acceptability

    Time frame: Baseline assessment (Week 1) to post-intervention assessment (Week 10)

    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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Piloting the Acceptability of a Culturally Tailored Evidence-Based mHealth Intervention for Low-Income Black Women With Breast Cancer

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2015
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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