Trial Information

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.