Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Biobehavioral Intervention in Reducing Stress and Improving Quality of Life in Patients With Newly Diagnosed Stage I-III Breast Cancer

Protocol: OSU-13127

Full Title

Psychological Changes in Breast Cancer Patients Participating in a Biobehavioral Intervention

Purpose

This clinical trial studies biobehavioral (psychological and behavioral) intervention in reducing stress and improving quality of life in patients with newly diagnosed stage I-III breast cancer. Psychological and behavioral interventions may reduce emotional distress, improve social support and dietary habits, reduce smoking, reduce symptoms, enhance immunity, reduce the risk for breast recurrence and may improve quality of life in patients with breast cancer.

Study Objective

PRIMARY OBJECTIVES:

I. Determine whether participants experience improvements on all outcomes, similar to improvements noted in the randomized clinical trial establishing the efficacy of the biobehavioral intervention (BBI).

OUTLINE:

Participants attend BBI sessions over 1.5 hours weekly for 18 weeks, biweekly for 8 weeks, and then monthly for 4 months. Participants learn adaptive coping strategies, including progressive muscle relaxation, assertive communication, health behavior change (e.g., diet and physical activity) and problem solving skills. Participants are also guided in seeking information, enhancing social support, enhancing body esteem and intimacy, and maintaining positive changes.

After completion of study, patients are followed up at 2 months.

Are you eligible?

Inclusion Criteria:

Newly diagnosed and surgically treated females with stage I-III breast cancer

Able to speak/read English

Able to give informed consent

Exclusion Criteria:

Non-ambulatory

Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit

Major mental illness (e.g., schizophrenia, psychotic disorder)

Breast Cancer