The adjustment process for cancer survivors may be burdensome and lengthy, but deteriorations in quality of life are underscored if they also have adverse health effects. In the general case, the immune system may be relevant to host resistance to progression and metastatic spread, but cancers etiologically linked to hormonal stimuli--such as breast cancer--may be particularly responsive to adverse, down-regulating factors. To guide the research, a Biobehavioral Model of cancer stress and disease course was proposed. The model includes psychological (stress and quality of life), behavioral (health behaviors and compliance), and biologic (neuroendocrine and immune) factors, and specifies the pathways by which health outcomes (e.g. disease endpoints--recurrence, disease free interval) might be affected.
Prior funding (R01 MH51487) enabled accrual of women (N of 200) with stage II or III breast cancer to an experiment testing the Biobehavioral Model. Accrual was completed and women were randomized between psychological/behavioral intervention and assessment only (no intervention) arms. Consistent with the Model, published data document that stress is related immune down regulation for women with cancer the earliest days following surgery (Andersen, Farrar, Golden-Kreutz, et al., 1998). Moreover, if left untreated, the stresses of diagnosis and surgery predict higher levels of depressive symptoms and lowered quality of life (Golden-Kreutz et al., 2004; in press).
Present funding provides for the testing of intervention efficacy; follow up of women for 5 years, and examination of disease endpoint effects. Current data show that women treated with the psychological intervention protocol show lowered stress, less dispersion in the chemotherapy dosages received, more positive health behaviors and fewer negative ones, and an increase in immune responses, as predicted (Andersen, Carson, Farrar, Golden-Kreutz et al., 2004). The ultimate aim of the research is to test the hypothesis that intervention subjects will show a doubling (ratio of median durations = 2.0) in time to recurrence, with a .05 level of significance and power of 0.80, one-sided test. We are continuing follow up assessments for years 2-5 and have begun follow up for years 6-10 when the risk for disease recurrence remains high. The research is yielding novel biobehavioral data, and the study is poised to experimentally test disease endpoint hypotheses.
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.