Post-treatment Care of Breast Cancer Survivors

Breast Neoplasm Clinical Trial

Official title:

Post-treatment Care of Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821288
• Other study ID #: AAAC5741
• Secondary ID: DISP0706868
• Status: Completed
• Phase: N/A
• First received: January 12, 2009
• Last updated: June 15, 2017
• Start date: July 2007
• Est. completion date: May 2013

Study information

• Verified date: June 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

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).
• 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.

Locations

Country	Name	City	State
United States	Columbia Unviersity Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FACIT-TS questionnaire score	This is designed to measure change in positive health related behavior.	Baseline, 6 months