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Clinical Trials/NCT00821288
NCT00821288
Completed
Not Applicable

Post-treatment Care of Breast Cancer Survivors

Columbia University1 site in 1 country140 target enrollmentJuly 2007
ConditionsBreast Neoplasm

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Neoplasm
Sponsor
Columbia University
Enrollment
140
Locations
1
Primary Endpoint
Change in FACIT-TS questionnaire score
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The overall goal of this proposal is to improve the post-treatment care of breast cancer survivors and to understand the barriers to optimal post-treatment care in Latina and Non-Hispanic women.

Detailed Description

The proposed investigation is a randomized prospective evaluation of a Survivorship Intervention in improving the quality of care, treatment satisfaction and understanding of care in Latina and Caucasian breast cancer survivors treated in an urban academic medical center. Patients will be recruited within 6 weeks of completing their last definitive breast cancer therapy (radiation or chemotherapy). Patients will complete self administered baseline and follow-up questionnaires. Following baseline evaluation patients will be randomized to receiving either written information for follow-up care of cancer survivors published by the National Cancer Institute (Facing Forward), or the Survivorship Intervention. Patients will not be aware that they are participating in a randomized intervention. After verbally agreeing to participate they will be randomized to group A or B and will receive the corresponding consent. Patients will be re-assessed 3 and 6 months after enrollment.

Registry
clinicaltrials.gov
Start Date
July 2007
End Date
May 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dawn L. Hershman

Associate Professor of Medicine & Epidemiology

Columbia University

Eligibility Criteria

Inclusion Criteria

  • Participants will be screened for the following inclusion criteria:
  • Age \>18 years
  • History of stage 0, I, II, or IIIa breast cancer and no evidence of recurrent disease
  • Within 6 weeks of completion of breast cancer therapy (Surgery, Radiation or Chemotherapy)
  • Caucasian and/or Hispanic (English or Spanish-speaking)
  • Willing to undergo a 1 hr cancer survivorship evaluation

Exclusion Criteria

  • Patients with the following active conditions or behaviors will be excluded from participation:
  • Evidence of recurrent or metastatic breast cancer
  • Patients who have received surgery only with no adjuvant therapy
  • Uncontrolled or significant psychiatric illness/social situations that would preclude completion of questionnaire or follow-up evaluation.

Outcomes

Primary Outcomes

Change in FACIT-TS questionnaire score

Time Frame: Baseline, 6 months

This is designed to measure change in positive health related behavior.

Study Sites (1)

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