Psychobiological Pathways: Breast Cancer Intervention
To test two behavioral interventions designed to enhance adjustment and lower recurrence and mortality among women with early versus late stage breast cancer.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||September 1999|
|Study Completion Date:||August 2005|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245219
|Investigator:||Michael Scheier||Carnegie Mellon University|