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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Donna Jeffe, Washington University Early Recognition Center
ClinicalTrials.gov Identifier:
NCT00929084
First received: June 24, 2009
Last updated: August 19, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 Study Completion Date: May 2015
Estimated Primary Completion Date: April 2015 (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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929084

Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Donna B Jeffe, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Donna Jeffe, Professor of Medicine, Director, Health Behavior, Communication and Outreach, Washington University Early Recognition Center
ClinicalTrials.gov Identifier: NCT00929084     History of Changes
Other Study ID Numbers: 000799
Study First Received: June 24, 2009
Last Updated: August 19, 2014
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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 21, 2014