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Stress and Immunity Breast Cancer Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03578627
Recruitment Status : Completed
First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Barbara Andersen, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Stage II Breast Cancer Stage III Behavioral: BioBehavioral Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Psychological/Immunity Studies With Women With Cancer Previously
Actual Study Start Date : May 1, 1994
Actual Primary Completion Date : May 31, 2000
Actual Study Completion Date : May 31, 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
No Intervention: Assessment-only
Experimental: 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.




Primary Outcome Measures :
  1. Recurrence event [ Time Frame: Ten years ]
    Diagnosis of pathologically confirmed breast cancer recurrence

  2. Recurrence time [ Time Frame: Ten years ]
    Time from the day of initial stage II or III breast cancer diagnosis to day of pathology confirmed breast cancer recurrence



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578627


Locations
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United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Barbara Andersen The Ohio State University Comprehensive Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Barbara Andersen, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03578627    
Other Study ID Numbers: 1992C0350
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases