Survivor Stories: Impact on Cancer Patients' Quality of Life and Follow-up
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Other: The Survivor Stories Tablet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Survivor Stories: Impact on Cancer Patients' Quality of Life and Follow-up |
- 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. [ Time Frame: Outcome measures are assessed at five time points: baseline, one month following primary treatment surgery, 6 months, one year, and two years post surgery. ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Outcome measures are assessed at five time points: baseline, one month following primary treatment surgery, 6 months, one year, and two years post surgery. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 220 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Survivor Stories Arm
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.
|
Other: The Survivor Stories Tablet
The Survivor Stories Tablet is a tablet computer where participants can browse an archive of 1-3 minute videotaped survivor stories told by African American Breast Cancer Survivors. Stories contain five main topics: coping, relationships, experiences with the health care system, follow-up care, and quality of life (QOL) living with breast cancer.
|
|
Control Arm
Women in the Control Arm will receive standard care.
|
Other: The Survivor Stories Tablet
The Survivor Stories Tablet is a tablet computer where participants can browse an archive of 1-3 minute videotaped survivor stories told by African American Breast Cancer Survivors. Stories contain five main topics: coping, relationships, experiences with the health care system, follow-up care, and quality of life (QOL) living with breast cancer.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- African American women
- First primary ductal carcinoma in situ (DCIS) or stages I, II, or III invasive breast cancer.
Exclusion Criteria:
- Prior DCIS or breast cancer diagnosis
- Stage IV or metastatic breast cancer
- Having received 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
Contacts and Locations| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| Principal Investigator: | Donna B Jeffe, PhD | Washington University School of Medicine |
More Information
No publications provided
| Responsible Party: | Donna Jeffe, Research Associate Professor of Medicine, Director, Health Behavior, Communication and Outreach, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00929084 History of Changes |
| Other Study ID Numbers: | 000799 |
| Study First Received: | June 24, 2009 |
| Last Updated: | March 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
Race Disparities Breast Cancer Quality of Life Treatment Adherence |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013