Clinical trial NCT00929084: Survivor Stories: Impact on Cancer Patients' Quality of Life and Follow-up
Official title: Survivor Stories: Impact on Cancer Patients' Quality of Life and Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Race Disparities
Breast Cancer
Quality of Life
Treatment Adherence
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2009-06-26
Enrollment: 228
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 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
* 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

Primary outcomes:
measure: 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.
timeFrame: 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 outcomes:
measure: 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
timeFrame: Outcome measures are assessed at five time points: baseline, one month following primary treatment surgery, 6 months, one year, and two years post surgery.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Donna B Jeffe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thompson T, Perez M, Kreuter M, Margenthaler J, Colditz G, Jeffe DB. Perceived social support in African American breast cancer patients: Predictors and effects. Soc Sci Med. 2017 Nov;192:134-142. doi: 10.1016/j.socscimed.2017.09.035. Epub 2017 Sep 22.
citation: Thompson T, Perez M, Yan Y, Kreuter MW, Margenthaler JA, Colditz GA, Jeffe DB. Randomized controlled trial of a breast cancer Survivor Stories intervention for African American women. Soc Sci Med. 2021 Feb;270:113663. doi: 10.1016/j.socscimed.2020.113663. Epub 2020 Dec 29.
citation: Perez M, Kreuter MW, Yan Y, Thompson T, Sefko J, Golla B, Margenthaler JA, Colditz G, Jeffe DB. Feasibility and Acceptability of an Interactive Cancer-Communication Video Program Using African American Breast Cancer Survivor Stories. J Health Commun. 2020 Jul 2;25(7):566-575. doi: 10.1080/10810730.2020.1821132. Epub 2020 Oct 13.
citation: Jarvandi S, Perez M, Margenthaler J, Colditz GA, Kreuter MW, Jeffe DB. Improving Lifestyle Behaviors After Breast Cancer Treatment Among African American Women With and Without Diabetes: Role of Health Care Professionals. Ann Behav Med. 2021 Feb 12;55(1):1-13. doi: 10.1093/abm/kaaa020.
citation: Schootman M, Perez M, Schootman JC, Fu Q, McVay A, Margenthaler J, Colditz GA, Kreuter MW, Jeffe DB. Influence of built environment on quality of life changes in African-American patients with non-metastatic breast cancer. Health Place. 2020 May;63:102333. doi: 10.1016/j.healthplace.2020.102333. Epub 2020 May 11.
citation: Cho B, Perez M, Jeffe DB, Kreuter MW, Margenthaler JA, Colditz GA, Liu Y. Factors associated with initiation and continuation of endocrine therapy in women with hormone receptor-positive breast cancer. BMC Cancer. 2022 Aug 1;22(1):837. doi: 10.1186/s12885-022-09946-x.