NCT00929084

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

5.2 years

First QC Date

June 24, 2009

Last Update Submit

February 3, 2025

Conditions

Keywords

Race DisparitiesBreast CancerQuality of LifeTreatment Adherence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (2)

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.

Other: The Survivor Stories Tablet

Control Arm

OTHER

Women in the Control Arm will receive standard care.

Other: The Survivor Stories Tablet

Interventions

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 ArmSurvivor Stories Arm

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Breast NeoplasmsTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHealth BehaviorBehavior

Study Officials

  • Donna B Jeffe, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Director, Health Behavior, Communication and Outreach Core

Study Record Dates

First Submitted

June 24, 2009

First Posted

June 26, 2009

Study Start

November 1, 2009

Primary Completion

January 1, 2015

Study Completion

December 1, 2016

Last Updated

February 6, 2025

Record last verified: 2025-02

Locations