Stress and Immunity Breast Cancer Project

Not Applicable

Completed

• Conditions: Breast Cancer Stage III; Breast Cancer Stage II
• Interventions: Behavioral: BioBehavioral Intervention

• Registration Number: NCT03578627
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

An investigative study of the effectiveness of the BioBehavioral Intervention on Stage II/III breast cancer patients. A total of 231 patients were split between an assessment-only control group and an experimental group receiving the Intervention and assessment. The goal of the Intervention is to use psychological, behavioral, and biologic methods with the primary goal of reducing cancer recurrence.

Detailed Description

Not available

Study Timeline

• Study Start: 1994-05-01
• Primary Completion: 2000-05-31
• Study Completion: 2000-05-31
• Study First Submitted: 2018-06-19
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-03
• Last Update Submitted: 2018-07-03
• Study First Posted: 2018-07-06
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 231

Inclusion Criteria

• Stage II or III breast cancer diagnosis prior to adjuvant therapy

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	BioBehavioral Intervention	-

Primary Outcome Measures

Name	Time	Method
Recurrence event	Ten years	Diagnosis of pathologically confirmed breast cancer recurrence
Recurrence time	Ten years	Time from the day of initial stage II or III breast cancer diagnosis to day of pathology confirmed breast cancer recurrence

Trial Locations

Locations (1)

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States