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Post-treatment Care of Breast Cancer Survivors

Primary Purpose

Breast Neoplasm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Survivorship Intervention
Facing Forward
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasm focused on measuring cancer survivorship, survivorship prescription, cancer related anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Columbia Unviersity Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Survivorship Intervention

Facing Forward

Arm Description

Latina and Caucasian breast cancer survivors treated in an urban academic medical center receiving Survivorship Intervention

Latina and Caucasian breast cancer survivors treated in an urban academic medical center receiving Survivorship Intervention Facing Forward: Life after Cancer Treatment manual

Outcomes

Primary Outcome Measures

Change in FACIT-TS questionnaire score
This is designed to measure change in positive health related behavior.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2009
Last Updated
June 15, 2017
Sponsor
Columbia University
Collaborators
Susan G. Komen Breast Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00821288
Brief Title
Post-treatment Care of Breast Cancer Survivors
Official Title
Post-treatment Care of Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2007 (Actual)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Susan G. Komen Breast Cancer Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm
Keywords
cancer survivorship, survivorship prescription, cancer related anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Survivorship Intervention
Arm Type
Experimental
Arm Description
Latina and Caucasian breast cancer survivors treated in an urban academic medical center receiving Survivorship Intervention
Arm Title
Facing Forward
Arm Type
Active Comparator
Arm Description
Latina and Caucasian breast cancer survivors treated in an urban academic medical center receiving Survivorship Intervention Facing Forward: Life after Cancer Treatment manual
Intervention Type
Behavioral
Intervention Name(s)
Survivorship Intervention
Other Intervention Name(s)
Survivorship Prescription
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Facing Forward
Other Intervention Name(s)
Life after Cancer Treatment manual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in FACIT-TS questionnaire score
Description
This is designed to measure change in positive health related behavior.
Time Frame
Baseline, 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn L Hershman, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia Unviersity Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23542954
Citation
Hershman DL, Greenlee H, Awad D, Kalinsky K, Maurer M, Kranwinkel G, Brafman L, Jayasena R, Tsai WY, Neugut AI, Crew KD. Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. Breast Cancer Res Treat. 2013 Apr;138(3):795-806. doi: 10.1007/s10549-013-2486-1. Epub 2013 Mar 31.
Results Reference
derived

Learn more about this trial

Post-treatment Care of Breast Cancer Survivors

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