Stress and Immunity Breast Cancer Project

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.

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Key information

Conditions

Breast Cancer Stage II Breast Cancer Stage III Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Stage II or III breast cancer diagnosis prior to adjuvant therapy

Exclusion criteria

Treatment and study plan

BioBehavioral Intervention

Behavioral

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 outcomes

Recurrence event

Time frame: Ten years

Diagnosis of pathologically confirmed breast cancer recurrence
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

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Psychological/Immunity Studies With Women With Cancer Previously

Important dates

Study start: 1994
Primary completion: 2000
Study completion: 2000
First posted: Jul 6, 2018
Registry last updated: Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed