Barbara L. Andersen - US grants

Approximately 80,000 cases of invasive gynecologic cancer are diagnosed annually in the United States and two-thirds of these women will survive at last 5 years. This encouraging prognosis contrasts with the distress attending disrupted life patterns and/or permanent body changes following cancer treatment. One life area that undergoes certain disruption for gynecologic cancer patients is sexual functioning. Before preventive or rehabilitative efforts can be implemented for such patients, information is needed on the specific nature, timing, and etiology of sexual difficulties for gynecologic cancer patients. Toward these objectives, the present research plan offers a controlled prospective longitudinal analysis of women's sexual functioning following the diagnosis and treatment of gynecologic cancer. The first aim of the proposed research plan determines the nature of sexual functioning for early stage cervical and endometrial cancer patients. This will be examined in two ways: (a) assessment of the range and frequency of sexual behavior, level of sexual responsiveness, and presence of sexual dysfunction; and (b) comparison of sexual functioning in women with gynecologic cancer with (i) a matched group of healthy women in no gynecologic distress, and (ii) a matched group of women with benign gynecologic disease. Group (i) will be used to estimate the base rate of sexual functioning deficits which occur under normal health and life circumstances, and Group (ii) will be used to estimate the level of sexual functioning deficits following non-life-threatening disease and major gynecologic treatment. The second aim provides delineation of the time point(s) at which gynecologic cancer patients experience sexual distress during the first postoperative year. For this, a prospective longitudinal methodology will be used in which subjects from the gynecologic cancer and the two comparison groups will be administered the sexual functioning assessment prior to treatment and at 4, 8 and 12 months posttreatment. The third aim proposes and tests a model of the contribution of sexual, medical, and psychosocial factors to the etiology of sexual distress among gynecologic cancer patients. Together these three aims will provide basic data on the nature of sexual functioning, the timing of sexual difficulties in the first postoperative year, and the variables which may be predictive of posttreatment sexual functioning. With these data, treatment programs focused on prevention can be designed to improve the quality of life for survivors of gynecologic cancer.

The adjustment for breast cancer survivors may be burdensome and lengthy. Evidence from psychoneuroimmunology literature shows that adjustment difficulties can produce certain biological effects, specifically the down regulation of the immune system. This project proposes to create a biobehavioral model of cancer stress and disease in breast cancer victims.

DESCRIPTION (Adapted from the Applicant Abstract): The adjustment process for breast cancer survivors may be burdensome and lengthy. There is also ample evidence from the psychoneuroimmunology (PNI) literature showing that adults undergoing acute and/or long term stressors experience high rates of adjustment difficulties and important biologic effects--persistent down regulation of the immune system. Thus, deteriorations in quality of life (QOL) with cancer are underscored if they also have adverse health effects. In the general case, the immune system may be relevant to host resistance against 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 is proposed. This model includes psychological (stress and quality of life), behavioral (health behaviors and compliance), and biologic (immune) factors, and specifies the pathways by which health outcomes (eg. disease endpoints--recurrence, disease-free interval) might be affected. We propose to test portions of the model with an experiment--a randomized clinical trial of a psychological intervention. Women with Stage II or III breast cancer will be randomized between psychological behavioral intervention and no intervention arms. Our hypothesis is that women being treated with the psychological intervention protocol will show lowered stress, increased QOL, more positive health behaviors and fewer negative ones, greater compliance, and an increase in immune functioning. In turn, we also anticipate that they will show a doubling (ratio of median duration=2)in time to recurrence, with a .05 level of significance and power of 0.80, one-sided test. Data from this proposal will provide 1) a test of a psychological intervention which is designed to reduce stress, enhance quality of life, increase positive health behaviors, decrease negative health behaviors, and improve compliance; 2) a test of the immune enhancing effects of such interventions; 3) a test of the health (cancer Outcome) consequences of such interventions; and, 4) a test of immunity as one mechanism which may link psychological/behavioral variables to cancer outcomes.

DESCRIPTION (provided by applicant): The K05 application for Barbara L. Andersen is submitted to enable a full time effort in cancer control research and mentoring. She is a professor in the Department of Psychology and a member of the Cancer Prevention and Control and the Immunology programs of the Comprehensive Cancer Center at the Ohio State University. A Biobehavioral Model of cancer stress and disease course (Andersen et al., 1994) provides a conceptual framework for the current research (CA92704, 7/01/01-6/30/06). The model includes psychological (stress and quality of life), behavioral (health behaviors and compliance), and biologic (endocrine and immune) factors and specifies the pathways for effects on health. A randomized clinical trial with breast cancer patients tests components of the model and efficacy of a psychological intervention. The research yields novel biobehavioral data, and the study is poised to experimentally test disease endpoint hypotheses. The K05 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 R01 trial. Since the previous submission, the recurrence study has been funded (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.

Active Follow-up; Alcohol Drinking; Alcohol consumption; Area; Behavior Conditioning Therapy; Behavior Modification; Behavior Therapy; Behavior Treatment; Behavior or Life Style Modifications; Behavioral; Behavioral Conditioning Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Breast Cancer Treatment; CRISP; Cancer Model; Cancer Patient; Cancer Treatment; Cancer of Breast; CancerModel; Change of Life, Female; Characteristics; Chemotherapy-Hormones/Steroids; Clinical; Clinical Trials; Clinical Trials, Unspecified; Computer Retrieval of Information on Scientific Projects Database; Conditioning Therapy; Diet, Fat-Restricted; Diet, Low-Fat; Disease; Disease Outcome; Disease Progression; Disorder; ER Status; Effectiveness; Endocrine; Endocrine Gland Secretion; Estrogen Receptor Status; EtOH drinking; Exercise; Exercise, Physical; Fat-Restricted Diet; Fats; Fatty acid glycerol esters; Funding; Grant; Health; Health behavior; Health behavior outcomes; Hormones; Immune; Immune Function, Cellular; Immune response; Immunity; Individual; Individual Differences; Institution; Intake; Intervention; Intervention Strategies; Investigators; Life Style Modification; Link; Literature; Malignant Neoplasm Therapy; Malignant Neoplasm Treatment; Malignant Tumor of the Breast; Malignant neoplasm of breast; Mediator; Mediator of Activation; Mediator of activation protein; Medical; Menopause; Modeling; NIH; National Institutes of Health; National Institutes of Health (U.S.); Neuroses; Neurotic Disorders; Numbers; Outcome; Personality; Positive Lymph Node; Psychoneuroses; QOL; Quality of life; Rate; Reporting; Research; Research Personnel; Research Resources; Researchers; Resources; Role; Rosa; Rose; Self Concept; Social support; Source; Specific qualifier value; Specified; Stratification Factors; Stress; Testing; Therapeutic Hormone; Time; United States National Institutes of Health; Woman; alcohol ingestion; alcohol intake; alcohol product use; alcohol use; alcoholic beverage consumption; alcoholic drink intake; anticancer therapy; base; behavior intervention; behavioral health; behavioral intervention; biobehavior; biobehavioral; cancer progression; cancer therapy; clinical investigation; design; designing; disease/disorder; ethanol consumption; ethanol drinking; ethanol ingestion; ethanol intake; ethanol product use; ethanol use; etoh use; follow-up; host response; immune function; immunoresponse; improved; interventional strategy; malignant breast neoplasm; menopausal; neoplasm progression; neoplastic progression; neurotic; neuroticism; node-positive; psychologic; psychological; psychological outcomes; psychosocial; response; social role; social support network; tumor progression

Active Follow-up; Alcohol Drinking; Alcohol consumption; Area; Behavior Conditioning Therapy; Behavior Modification; Behavior Therapy; Behavior Treatment; Behavior or Life Style Modifications; Behavioral; Behavioral Conditioning Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Breast Cancer Treatment; CRISP; Cancer Model; Cancer Treatment; Cancer of Breast; CancerModel; Change of Life, Female; Characteristics; Chemotherapy-Hormones/Steroids; Clinical; Clinical Trials; Clinical Trials, Unspecified; Computer Retrieval of Information on Scientific Projects Database; Conditioning Therapy; Diet, Fat-Restricted; Diet, Low-Fat; Disease; Disease Outcome; Disease Progression; Disorder; ER Status; Effectiveness; Endocrine; Endocrine Gland Secretion; Estrogen Receptor Status; EtOH drinking; Exercise; Exercise, Physical; Fat-Restricted Diet; Fats; Fatty acid glycerol esters; Funding; Grant; Health; Health behavior; Health behavior outcomes; Hormones; Immune; Immune Function, Cellular; Immune response; Immunity; Individual; Individual Differences; Institution; Intake; Intervention; Intervention Strategies; Investigators; Life Style Modification; Link; Literature; Malignant Neoplasm Therapy; Malignant Neoplasm Treatment; Malignant Tumor of the Breast; Malignant neoplasm of breast; Mediator; Mediator of Activation; Mediator of activation protein; Medical; Menopause; Modeling; NIH; National Institutes of Health; National Institutes of Health (U.S.); Neuroses; Neurotic Disorders; Numbers; Outcome; Patients; Personality; Positive Lymph Node; Psychoneuroses; QOL; Quality of life; Rate; Recurrence; Recurrent; Reporting; Research; Research Personnel; Research Resources; Researchers; Resources; Role; Rosa; Rose; Self Concept; Social support; Source; Specific qualifier value; Specified; Stratification Factors; Stress; Testing; Therapeutic Hormone; Time; United States National Institutes of Health; Woman; alcohol ingestion; alcohol intake; alcohol product use; alcohol use; alcoholic beverage consumption; alcoholic drink intake; anticancer therapy; base; behavior intervention; behavioral health; behavioral intervention; biobehavior; biobehavioral; cancer progression; cancer recurrence; cancer therapy; clinical investigation; design; designing; disease/disorder; ethanol consumption; ethanol drinking; ethanol ingestion; ethanol intake; ethanol product use; ethanol use; etoh use; follow-up; host response; immune function; immunoresponse; improved; interventional strategy; malignant breast neoplasm; menopausal; neoplasm progression; neoplastic progression; neurotic; neuroticism; node-positive; psychologic; psychological; psychological outcomes; psychosocial; response; social role; social support network; tumor progression

DESCRIPTION (provided by applicant): Worldwide, cancer is a leading cause of death and the most common killer of adult Americans. For the individual, the diagnosis is accompanied by extreme stress. Multiple randomized clinical trials (RCTs) of psychological interventions have shown efficacy in reducing stress for the "typical" patient-newly diagnosed with local or regional disease. Unfortunately, only two (N=2) RCTs have focused upon the patient with recurrent disease, leaving this patient group adrift in the sea of previous and present day cancer control research. The proposed project is designed to address this important need, by refining and pilot testing a promising intervention. A two-phase project, accruing patients newly diagnosed cancer recurrence (N=96) is proposed. Breast or gynecologic patients will be accrued, as these are the 1st and 3rd most prevalent sites among women and together account for 40% of annual diagnoses. Phase I will employ a focus group methodology for three aims: 1) provide clinical detail on the unique needs of patients facing recurrence;2) understand the frequency and perceived effectiveness of patients'own coping strategies;and, 3) solicit patient perceptions of intervention strategies shown to be effective with other cancer populations. Using these data, we will modify a previously tested psychological treatment-the Biobehavioral Intervention (BBI;Andersen et al., 2004;2007;in press)- found to be effective for reducing Stage II/III breast cancer patients'stress, improving health behaviors and treatment adherence, enhancing immunity, and reducing the risk of recurrence and death. In Phase II the revised intervention will be pilot tested to achieve three aims: 1) test the acceptability and feasibility of the intervention;2) test of the efficacy of the intervention to affect biobehavioral outcomes;and 3) assemble clinical detail, estimate effect sizes, and discover factors producing variability in patient outcomes, if any. The intervention will be tested in both individual and group formats with the latter including both homogeneous and heterogeneous disease site patient participants. Completion of both phases leads an experienced investigator group to their over arching aim: Conduct of a randomized clinical trial testing the efficacy of a psychological intervention tailored to the needs of this important, but underserved, cancer patient group. PUBLIC HEALTH RELEVANCE: With over 1.3 million new cancer diagnoses per year, more than half a million individuals will face recurrence and succumb to their disease. Despite the numbers, little psychosocial research has focused on the plight of those with recurrence. This research advances public mental health by providing an important first step in developing and testing a psychological intervention to decrease psychological symptoms and improve health, thereby reducing burden to cancer patients, their families, and the health care system.

DESCRIPTION (provided by applicant): As noted in the 2008 Institute of Medicine report, Cancer care for the whole patient: Meeting psychosocial health needs, the psychological distress of the vast majority of cancer patients is not addressed, posing a serious public health problem for the U.S. health care system. The NCI has acknowledged this by designating supportive care and quality of life issues of cancer survivors as health priority areas. However, progress has been limited for at least two reasons: 1) There is a gulf between the availability of empirically supported treatments (ESTs) that can produce psychosocial and health benefits for patients and their dissemination; and, 2) There are few mechanisms for supportive care professionals to receive any training in the latest developments in evidence based cancer control approaches. To address both gaps, 8 three-day training institutes are proposed for competitively selected (N=320) psychologist, social worker, and mental health clinical nurse specialists. The curriculum will be the empirically supported Biobehavioral Intervention (BBI). This treatment has yielded robust and enduring gains, including reductions in patients' emotional distress, improvements in social support, treatment adherence (chemotherapy), health behaviors (diet, smoking), and symptom and functional status, and reduced risk for cancer recurrence. Training components will include stress reduction, communication with health care providers, social support, problem solving, health behaviors, sexuality, and maintenance of change. Guided by the RE-AIM model (Reach, Effectiveness, Adoption, Implementation, Maintenance) of Abrams [1] and Glasgow et al. [2] program evaluation and dissemination will have a multi-level plan, with primary level benchmarks being success in educating trainees in BBI understanding and delivery; the secondary level being the trainee's clinical use of BBI; the tertiary level being an open label (phase II) trial of the BBI as disseminated to and implemented by trainees; and, the fourth level benchmarks being adoption of the BBI at the trainees' institution and uptake of the published BBI therapist and patient manuals. The overarching goal is to train supportive care professionals in the use of the BBI in order to improve care of cancer patients and survivors by the delivery of empirically supported psychosocial treatment.

DESCRIPTION (provided by applicant): Worldwide, gynecologic cancer is a leading cause of death. In the U.S. more than 80,000 diagnoses are made annually, making gynecologic tumors the third most prevalent disease site for women. For the patient, diagnosis is accompanied by extreme stress, with multimodal therapies to follow. Hundreds of randomized clinical trials (RCTs) of psychological interventions for cancer patients have been conducted, but only 21 enrolled gynecologic patients. For these patients, one of the most disruptive and long-lasting sources of morbidity is sexual, second only to extremity lymphedema. Over 50% of patients have moderate-to-severe sexual disruption, as documented with 30+ years of descriptive studies. Of the previous 21 trials, only 5 of them have included a sexual functioning component (typically one session) in the intervention, and in all cases this dose of treatment yielded null effects or only minimal change. Thus, the proposed research addresses this gap by pilot testing a novel, theoretically driven, psychological intervention to prevent sexual morbidity. A small RCT is proposed. Recently diagnosed, post surgery gynecologic cancer patients (N=50) will be accrued and randomized to: Psychological Intervention vs. Control (Enhanced Standard Care; ESC). Patients will be assessed at intake (baseline), and 3-, 6-, and 9-months. ESC will include three elements: stress reduction (progressive muscle relaxation), information delivery regarding gynecologic cancer treatments and sexuality, and provision of survivorship care plan documents. For the intervention arm, the investigators' build on their program of basic research in sexuality by framing the core intervention elements (sex therapy, cognitive-behavior therapy, problem solving) in the theoretical context of sexual self schema enhancement. Patients will receive four weekly, four biweekly, and two monthly sessions, for a total of ten sessions spaced across five months. The Intervention will be provided in both individual and group formats to ascertain dissemination information. Primary outcome measures assess sexual behavior, responsiveness, and satisfaction, and sexual pain. Secondary outcomes include emotional distress, depressive symptoms, and fatigue. Important for later dissemination, procedures are in place to collect cost-effectiveness data. Completion of the proposed research leads an experienced, interdisciplinary, investigator team to their overarching goal: conduct of a large-scale RCT testing the efficacy of a tailored psychological intervention suited for dissemination to this underserved and burdened cancer patient group. This is a high-impact research program that, if successful, will change the trajectory of sexual morbidity and substantively improve gynecologic cancer survivorship.