Skip to content

Stress and Immunity Breast Cancer Project

Psychological/Immunity Studies With Women With Cancer Previously

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03578627
Enrollment
231
Registered
2018-07-06
Start date
1994-05-01
Completion date
2000-05-31
Last updated
2018-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Stage II, Breast Cancer Stage III

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.

Interventions

BEHAVIORALBioBehavioral 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.

Sponsors

Ohio State University Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Recurrence eventTen yearsDiagnosis of pathologically confirmed breast cancer recurrence
Recurrence timeTen yearsTime from the day of initial stage II or III breast cancer diagnosis to day of pathology confirmed breast cancer recurrence

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026