Back to resultsStress and Immunity Breast Cancer Project
Primary Purpose
Breast Cancer Stage II, Breast Cancer Stage III
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BioBehavioral Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer Stage II
Eligibility Criteria
Inclusion Criteria:
- Stage II or III breast cancer diagnosis prior to adjuvant therapy
Exclusion Criteria:
-
Sites / Locations
- Ohio State University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Assessment-only
Intervention
Arm Description
Outcomes
Primary Outcome Measures
Recurrence event
Diagnosis of pathologically confirmed breast cancer recurrence
Recurrence time
Time from the day of initial stage II or III breast cancer diagnosis to day of pathology confirmed breast cancer recurrence
Secondary Outcome Measures
Full Information
NCT ID
NCT03578627
First Posted
June 19, 2018
Last Updated
July 3, 2018
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT03578627
Brief Title
Stress and Immunity Breast Cancer Project
Official Title
Psychological/Immunity Studies With Women With Cancer Previously
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 1994 (Actual)
Primary Completion Date
May 31, 2000 (Actual)
Study Completion Date
May 31, 2000 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Stage II, Breast Cancer Stage III
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
231 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Assessment-only
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
BioBehavioral Intervention
Intervention Description
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 Measure Information:
Title
Recurrence event
Description
Diagnosis of pathologically confirmed breast cancer recurrence
Time Frame
Ten years
Title
Recurrence time
Description
Time from the day of initial stage II or III breast cancer diagnosis to day of pathology confirmed breast cancer recurrence
Time Frame
Ten years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage II or III breast cancer diagnosis prior to adjuvant therapy
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Andersen
Organizational Affiliation
The Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30762400
Citation
Conley CC, Andersen BL. Lemons to lemonade: Effects of a biobehavioral intervention for cancer patients on later life changes. Health Psychol. 2019 Mar;38(3):206-216. doi: 10.1037/hea0000717.
Results Reference
derived
Links:
URL
http://cancer.osu.edu
Description
The Jamesline
Learn more about this trial
Stress and Immunity Breast Cancer Project
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