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Post-treatment Care of Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821288
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : June 19, 2017
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Dawn L. Hershman, Columbia University

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Behavioral: Survivorship Intervention Behavioral: Facing Forward Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Post-treatment Care of Breast Cancer Survivors
Actual Study Start Date : July 2007
Actual Primary Completion Date : October 2011
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Survivorship Intervention
Latina and Caucasian breast cancer survivors treated in an urban academic medical center receiving Survivorship Intervention
Behavioral: Survivorship Intervention
Survivorship Consultation is a one hour consultation in a survivorship clinic. The consultation will be performed by a nurse practitioner under the supervision of a medical oncologist. The consultation will result in a detailed written document outlining the individuals "Survivorship Prescription" including treatment summary, surveillance recommendations, risk for late-effects, cancer screening recommendations, genetic risk, and life style recommendations. This written document will be provided to the patient and her treating physician. In addition, referrals will be made to appropriate adjunct services as needed (e.g. psychologist, nutritionist, social worker).
Other Name: Survivorship Prescription

Active Comparator: Facing Forward
Latina and Caucasian breast cancer survivors treated in an urban academic medical center receiving Survivorship Intervention Facing Forward: Life after Cancer Treatment manual
Behavioral: Facing Forward
Facing Forward: Life after Cancer Treatment is a guide for people who were treated for cancer published by the NCI. It is a 24-page manual that summarized many key issues of interest to cancer survivors during the re-entry phase, and contains sections on medical care after treatment, symptoms after treatment, feelings after treatment, social relationships after cancer treatment, and dealing with practical matters such as insurance and employment. The manual is available in English and Spanish. This will be given at the time of registration and the table of contents will be reviewed with the patient.
Other Name: Life after Cancer Treatment manual




Primary Outcome Measures :
  1. Change in FACIT-TS questionnaire score [ Time Frame: Baseline, 6 months ]
    This is designed to measure change in positive health related behavior.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821288


Locations
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United States, New York
Columbia Unviersity Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Susan G. Komen Breast Cancer Foundation
Investigators
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Principal Investigator: Dawn L Hershman, MD Columbia University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dawn L. Hershman, Associate Professor of Medicine & Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT00821288    
Other Study ID Numbers: AAAC5741
DISP0706868 ( Other Grant/Funding Number: The Susan Komen Foundation )
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dawn L. Hershman, Columbia University:
cancer survivorship
survivorship prescription
cancer related anxiety
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases