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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929084
• Other study ID #: 000799
• Status: Completed
• Phase: N/A
• Start date: November 2009
• Est. completion date: December 2016

Study information

• Verified date: August 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: December 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

• 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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Outcome measures are assessed at five time points: baseline, one month following primary treatment surgery, 6 months, one year, and two years post surgery.
Secondary	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.