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临床试验/NCT02463474
NCT02463474已完成不适用

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

University of Florida2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2
主要终点
Breast Cancer Knowledge

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Breast Cancer Knowledge

时间窗: 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.

次要结局

  • Perceived Stress Scale(Baseline assessment (Week 1) to post-intervention assessment (Week 10))
  • Functional Assessment of Cancer Therapy-Breast (FACT-B)(Baseline assessment (Week 1) to post-intervention assessment (Week 10))
  • Perceived Involvement in Care Scale(Baseline assessment (Week 1) to post-intervention assessment (Week 10))
  • Acceptability(Baseline assessment (Week 1) to post-intervention assessment (Week 10))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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