Post-treatment Care of Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Breast Neoplasm
• Interventions: Behavioral: Survivorship Intervention; Behavioral: Facing Forward

• Registration Number: NCT00821288
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2009-01-12
• Study First Submitted QC: 2009-01-12
• Study First Posted: 2009-01-13
• Primary Completion: 2011-10
• Study Completion: 2013-05
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in FACIT-TS questionnaire score	Baseline, 6 months	This is designed to measure change in positive health related behavior.

Trial Locations

Locations (1)

Columbia Unviersity Medical Center; 🇺🇸 New York, New York, United States