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临床试验/NCT00929084
NCT00929084已完成不适用

Survivor Stories: Impact on Cancer Patients' Quality of Life and Follow-up

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2009年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
228
试验地点
2
主要终点
Determine to what extent African American breast cancer survivor stories affect various aspects of QOL, including depressed mood and concern about recurrence, among African American breast cancer patients following primary treatment.

研究概览

简要总结

The purpose of this study is to evaluate in a randomized controlled trail, an innovative cancer communication strategy to help African American breast cancer patients cope with a variety of challenges during and after treatment and to better adhere to recommended treatment guidelines and follow-up care.

详细描述

Disparities in incidence and mortality between African Americans and Caucasians for a number of cancers have been well documented. This study builds on previous work in St. Louis to overcome barriers to access to breast screening, identifying and addressing factors associated with access to care once diagnosed, and factors contributing to delay in diagnosis and completion of therapy. African American breast cancer patients randomly assigned to the intervention arm of the trial will have access to the Survivor Stories Tablet, a tablet computer, on which they will browse an archive of 1-3 minute videotaped survivor stories about five topics: coping, relationships, experiences with the health care system, follow-up care, and quality of life (QOL) living with breast cancer. Patients will have the tablet for two weeks after enrollment in the study, and again at 6 and 12 months. Patients in the control arm will receive usual care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • African American women
  • First primary ductal carcinoma in situ (DCIS) or stages I, II, or III invasive breast cancer.

排除标准

  • Prior DCIS or breast cancer diagnosis
  • Stage IV or metastatic breast cancer
  • Planned to receive a double mastectomy
  • non-English speaking,
  • Having known psychiatric or neurologic disorders
  • Being cognitively impaired according to weighted error scores on the Orientation-Memory-Concentration Test
  • Being unwilling or unable to give consent

研究组 & 干预措施

Control Arm

Other

Women in the Control Arm will receive standard care.

干预措施: The Survivor Stories Tablet (Other)

Survivor Stories Arm

Other

Women in the Survivor Stories intervention arm will be given the Survivor Stories Tablet to take home for two weeks at three different time points over a two year period.

干预措施: The Survivor Stories Tablet (Other)

结局指标

主要结局

Determine to what extent African American breast cancer survivor stories affect various aspects of QOL, including depressed mood and concern about recurrence, among African American breast cancer patients following primary treatment.

时间窗: Outcome measures are assessed at five time points: baseline, one month following primary treatment surgery, 6 months, one year, and two years post surgery.

次要结局

  • Determine whether and to what extent African American breast cancer survivor stories affect African American breast cancer patients' adherence to recommended surveillance mammography and prescribed hormone therapy(Outcome measures are assessed at five time points: baseline, one month following primary treatment surgery, 6 months, one year, and two years post surgery.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Donna Jeffe

Professor of Medicine, Director, Health Behavior, Communication and Outreach Core

Washington University School of Medicine

研究点 (2)

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