Post-treatment Care of Breast Cancer Survivors
June 15, 2017 updated by: Dawn L. Hershman, Columbia University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia Unviersity Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Survivorship Intervention
Latina and Caucasian breast cancer survivors treated in an urban academic medical center receiving 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 Names:
|
|
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
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in FACIT-TS questionnaire score
Time Frame: Baseline, 6 months
|
This is designed to measure change in positive health related behavior.
|
Baseline, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dawn L Hershman, MD, Columbia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2007
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
January 12, 2009
First Submitted That Met QC Criteria
January 12, 2009
First Posted (Estimate)
January 13, 2009
Study Record Updates
Last Update Posted (Actual)
June 19, 2017
Last Update Submitted That Met QC Criteria
June 15, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAC5741
- DISP0706868 (Other Grant/Funding Number: The Susan Komen Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.