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NCT03578627 Clinical Trial

Stress and Immunity Breast Cancer Project

Breast Cancer Stage II Clinical Trial

Official title:
Psychological/Immunity Studies With Women With Cancer Previously

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03578627
Other study ID # 1992C0350
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 1994
Est. completion date May 31, 2000

Study information
Verified date July 2018
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 231
Est. completion date May 31, 2000
Est. primary completion date May 31, 2000
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• BioBehavioral Intervention
Psychological (stress and quality of life), behavioral (health behaviors and compliance), and biologic (neuroendocrine and immune) factors, and pathways by which health outcomes (e.g. disease endpoints—recurrence, disease free interval) might be affected.

Locations
Country Name City State
United States Ohio State University Medical Center Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence event Diagnosis of pathologically confirmed breast cancer recurrence Ten years
Primary Recurrence time Time from the day of initial stage II or III breast cancer diagnosis to day of pathology confirmed breast cancer recurrence Ten years
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