In 1994 a randomized clinical trial began to test the hypothesis that stress accompanying a cancer diagnosis would trigger psychological and behavioral responses, as well as biological responses, relevant to disease progression. We reasoned that receipt of a psychological intervention might serve as a protective mechanism to significantly alter the chain of adverse stress effects, and thereby reduce the risk for cancer recurrence. Newly diagnosed patients (N=227) who had received surgical treatment for Stage II or III breast cancer were accrued and randomized to study arms: psychological intervention plus assessment vs. assessment only (monitoring).
The goals of the psychological intervention were to reduce distress and improve quality of life, improve health behaviors (diet, exercise, smoking cessation), and facilitate cancer treatment compliance and medical follow-up. As previously reported, statistical analyses demonstrated that the patients in the Intervention arm significantly improved across all secondary outcomes (psychological, behavioral, health) as well as immunity factors (higher levels of phytohemagglutinin (PHA) and concanavalin A (ConA) T cell blastogenesis) compared with patients in the Assessment arm.
In 2008 after a median of 11 years of follow-up, disease recurrence was reported to occur in 62 of 212 (29%) women and death was reported for 54 of 227 (24%) women. Using Cox proportional hazards analysis, multivariate comparison of survival was conducted. As predicted, patients in the intervention arm were found to have a reduced risk of breast cancer recurrence (hazards ratio [HR] of 0.55; P 5.034). Follow-up analyses also suggested a reduced risk of death from breast cancer (HR of 0.44; P 5.016) and risk of death from all causes (HR of 0.51; P 5.028) for the breast cancer patients randomized to receive the psychological intervention. For comparison, we note that the 5-year survival rate for the stage II patients in the trial from both study arms was 90%, which compares favorably with rates from the same period for the state of Ohio (84%) and the surrounding county (Franklin) for Columbus, Ohio (83%).
We continue to follow and support out SIBCP participants. We are most appreciative of their previous and continued participation, their guidance, and their many contributions to our ongoing studies of breast cancer survivorship.
Cancer recurrence is devastating. The numbers of recurrence diagnoses per year is staggering, 1.2 million expected in 2003, and over half of the individuals will quickly succumb to disease progression. Despite the numbers, only modest attention has come from the cancer control community, and research progress is in the earliest of phases. The research objectives include the following: 1) Testing a model of biobehavioral responses to cancer and its extension to cancer recurrence; 2) Conducting a prospective, longitudinal study of patients' responses to breast cancer recurrence; 3) Comparing and distinguishing the biobehavioral responses of women with recurrence with matched, but disease free, patients who have been followed for an equivalent interval; and, 4) Gathering clinical information and preliminary data for the design of a randomized, clinical trial of a psychological intervention for patients with cancer recurrence. Study groups are women previously diagnosed with stage II/III breast cancer that have recurred (n = 75) or remained disease free (n = 75-150). Data consist of biobehavioral measures/outcomes--psychological, behavioral, medical, and biologic (immune and endocrine). The proposal addresses gaps in the literature, the research designs will describe the spectrum of responses prior to and following the recurrence event, and the data will provide direction for interventions and document recurrence as an important topic for cancer control research initiatives.
The KO5 research goal is to extend the biobehavioral approach to the context of cancer recurrence. Despite its clinical importance, cancer recurrence has received little systematic study. The proposed controlled, prospective, longitudinal design has powerful methodological and scientific advantages, would yield unique data, and test related hypotheses of the RO1 trial. See grant above for specific research funding for the recurrence study (RSGPB-03-248; 7/1/03-6/30/08).
The KO5 mentoring goal would continue Andersen's successful record during the past 20+ years of mentoring pre and postdoctoral trainees. She admits students with exceptional academic records who become trainee-collaborators in her interdisciplinary cancer control research. Enhanced mentoring is proposed to increase the trainees' level of professional maturity, enhance their scholarly record, and facilitate the transition of the 'best and the brightest' to careers as independent investigators and leaders in cancer prevention and control.
There are significant racial and ethnic disparities in outcome among women in the United States with different types of gynecologic cancer. We are testing hypotheses that poor outcomes among minorities with gynecologic cancer exists because of biological differences in tumors related to race and ethnicity; culture, social and psychological barriers to accessing care; less than optimal screening services and prevention strategies; and, unequal provision of quality health care and tailored therapeutics.
Project 2 of the Center grant will be divided into two phases. For Part I (Survey) gynecologic cancer survivors who have been treated within the last 10 years will be contacted. We will focus upon racial/ethnic minorities as well as women of lower socioeconomic status. This is particularly important, as there are minimal data on quality of life outcomes for such individuals. The survey will include quality of life (QoL), depression, mood, social involvement, cancer specific stress, sexuality, and fatigue. During year 1 the procedures and assessments will be piloted with a sample (N = 500) from the OSU gynecologic cancer survivor cohort. When finalized, the survey will be implemented with survivors from the Walter Reed Army Hospital catchments area. In Part II (Intervention), women will be accrued for a pilot testing of the efficacy of a stress reduction and sexuality intervention for reducing psychological and sexual morbidity. A sample of 80 women with newly diagnosed stage I or II (all sites) or good prognosis Stage III (cervix and endometrial only) disease from the gynecologic oncology service of the Ohio State University Comprehensive Cancer Center will be accrued. In combination, Parts I and II provide pilot data addressing the most pressing needs for quality of life research in gynecologic cancer: the need for descriptive data from underserved populations and the testing of psychological interventions to reduce morbidity and enhance quality of life.