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Post-Treatment Care of Breast Cancer Survivors
This study is currently recruiting participants.
Verified by Columbia University, January 2009
Sponsors and Collaborators: Columbia University
Susan G. Komen Breast Cancer Foundation
Information provided by: Columbia University
ClinicalTrials.gov Identifier: NCT00821288
  Purpose

More than 2 million women living in the United States today are breast cancer survivors. Limited data exist on the experiences of women during the critical transitional period between the end of primary treatment and survivorship. Minorities are typically underrepresented in most studies that examined the quality of life and psychosocial functioning of cancer survivors, and this is especially true of non-English speaking minority populations. 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 women. 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. We will recruit 120 patients (60 Hispanic and 60 non-Hispanic) within 4 weeks of completing their last definitive breast cancer therapy (radiation therapy or chemotherapy). Subjects will complete self administered baseline and follow-up questionnaires 3 months after intervention. Following baseline evaluation, patients will review written information for follow-up care of cancer survivors - Facing Forward: Life after Cancer Treatment and undergo a comprehensive consultation in a survivorship clinic where an individualized report including a treatment summary, surveillance recommendations, risk for late-effects, cancer screening recommendations, genetic risk, and life style recommendations will be generated and provided to the patient and physician. Patients will be re-assessed 3 months after the intervention. Cancer therapy related symptoms, understanding of the recommended treatment plan, treatment satisfaction, and the psychosocial impact of being a cancer survivor will be evaluated, and assessed in relation to ethnicity (Hispanic vs non-Hispanic), primary language, literacy and socioeconomic status. We hypothesize that patients will differ in rates of cancer therapy related symptoms, understanding of the recommended treatment plan, treatment satisfaction, and the psychosocial impact of being a cancer survivor in relation to ethnicity (Hispanic vs non-Hispanic), primary language, literacy and socioeconomic status. We also hypothesize that the intervention will improve patents understanding of the recommended treatment plan, treatment satisfaction and long term risk. We believe in the long-term this Survivorship Intervention will have a positive impact on follow-up and surveillance guidelines, adherence to standard cancer screening, and understanding of lifestyle modification recommendations (low fat diet/exercise).


Condition Intervention Phase
Breast Neoplasm
Behavioral: survivorship prescription
Behavioral: facing forward
Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Anxiety Breast Cancer Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Post-Treatment Care of Breast Cancer Survivors

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Cancer related anxiety [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2008
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Survivorship intervention
Behavioral: survivorship prescription
lifestyle and post-treatment information
2: Sham Comparator
Survivorship book
Behavioral: facing forward
book

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821288

Locations
United States, New York
Columbia Unviersity Medical Center Recruiting
New York, New York, United States, 10032
Contact: Dawn Hershman, MD     212-305-1945     dlh23@columbia.edu    
Principal Investigator: Dawn L Hershman, MD            
Sponsors and Collaborators
Columbia University
Susan G. Komen Breast Cancer Foundation
  More Information

Responsible Party: Columbia University ( Dawn Hershman )
Study ID Numbers: IRB-AAAC5741
Study First Received: January 12, 2009
Last Updated: January 12, 2009
ClinicalTrials.gov Identifier: NCT00821288  
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
cancer survivorship
survivorship prescription
cancer related anxiety

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009