Stress and Immunity Breast Cancer Project

NCT ID: NCT03578627

Last Updated: 2018-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-05-01

Study Completion Date

2000-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Stage II Breast Cancer Stage III

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Assessment-only

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Group Type EXPERIMENTAL

BioBehavioral Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Barbara Andersen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara Andersen

Role: PRINCIPAL_INVESTIGATOR

The Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30762400 (View on PubMed)

Related Links

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Other Identifiers

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1992C0350

Identifier Type: -

Identifier Source: org_study_id

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