Psychobiological Pathways: Breast Cancer Intervention

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00245219
First received: October 26, 2005
Last updated: January 18, 2008
Last verified: January 2008
  Purpose

To test two behavioral interventions designed to enhance adjustment and lower recurrence and mortality among women with early versus late stage breast cancer.


Condition Intervention
Breast Neoplasms
Behavioral: health education
Behavioral: stress management

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1999
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

The study was a subproject within a Mind-Body Center on Understanding Shared Psychobiological Pathways. The Center was in response to a Request for Applications issued by the Office of the Director, NIH. Dr. Scheier was the Principal Investigator of the Center as well as the subproject principal investigator. The major objective of the Center was to to identify, measure, and understand the shared psychological, behavioral, and psychobiological pathways that contributed to the onset of and recovery from diverse physical illnesses, which included infections, arthritis, cancer, and cardiovascular disease.

The subproject studied an important area of psychosocial research in cancer, that was the testing of interventions in clinical trials and the determination of which interventions benefitted which patients and at which stage. The "one size fits all" approach was no longer appropriate as studies began to identify the efficacy of different approaches. This project addressed the best approach for early and advanced breast cancer, basing it on a rational consideration of the problems being confronted by women at each stage, leading to a determination of the most appropriate intervention.

DESIGN NARRATIVE:

The specific aims of the project were to: (1) implement and evaluate a two-arm intervention designed to enhance adjustment, and lower recurrence and mortality among women with early- vs. late-stage breast cancer; (2) determine the psychological, behavioral, and biological mechanisms through which the interventions operate; (3) assess whether the two arms of the intervention were differentially effective for women with different characteristics, most importantly early- vs. late-stage disease; (4) use the baseline data collected prior to the intervention to determine the nature and extent of difficulties faced by early- vs. late-stage breast cancer patients; and (5) determine how participants in the intervention differed from those who choose to participate.

An estimated 420 women, age 25 and above, were randomly assigned to one of two active arms of an intervention program or a treatment-as-usual control group. One active arm of the intervention consisted of group education sessions (lasting 1 hour/week for 8 weeks), in which women were provided with information about breast cancer and taught adaptive coping strategies and stress management techniques. The second arm of the intervention consisted of group peer support sessions (also lasting 1 hour/week for 8 weeks), in which the women were encouraged to share their experiences in an attempt to provide a sense of emotional support, promote altruism among group members, and supply group members with an enhanced sense of purpose and meaning in life. Hypothesized predictors, mediators, and relevant outcome measures were assessed prior to the intervention. Mediators and outcomes were then reassessed, both when the intervention ended and 6-months later. Analyses focused on evaluating the benefits of the intervention, and identifying who benefited from which intervention and why the benefit occurred.

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00245219

Sponsors and Collaborators
Investigators
Investigator: Michael Scheier Carnegie Mellon University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00245219     History of Changes
Other Study ID Numbers: 338
Study First Received: October 26, 2005
Last Updated: January 18, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 29, 2014