Anne E. Kazak - US grants

In this proposal we outline a multidisciplinary educational intervention for staff, patients, and families of pediatric cancer patients which focuses on reducing pain and distress during medical procedures. The specific aims of the Analgesia Protocol for Procedures in Oncology (APPO) are to: (1). develop an integrated pharmacological/psychological protocol for procedures, following the recommendations of the Consensus Conference on the Management of Pain in Childhood Cancer; (2). expand education and interventions for families in assessing and coping with procedural pain and distress; (3). prepare and implement programs and materials for multidisciplinary education and involvement in pain management; (4). use quantitative methods to demonstrate the effectiveness of the protocol for staff, patients, and families, including research looking at the ways in which such programs can be implemented; and (5). disseminate the results of our work to staff, patients, and families, including hosting conferences on the use of the protocol and means of introducing APPO in other hospital and clinic settings. New pharmacological guidelines will be utilized for all patients. The APPO intervention (new guidelines plus family assessment and specialized intervention) will be introduced initially to all new patients with leukemia at The Children's Hospital of Philadelphia (N=48/year. Patients will be randomized to APPO (with an individualized psychological intervention plan) or the existing psychosocial services for the first year. In Years 2 and 3 all patients with leukemia and other pediatric cancers will be offered APPO. Multidisciplinary staff education will begin before the initiation of APPO, and continue over the three year period.

Increasingly aggressive medical treatment has resulted in a dramatic rise in the number of childhood cancer survivors over the past two decades. While "cured" of cancer, these children and adolescents are at risk for significant medical and psychological sequelae. In the present study, we propose and test a post-traumatic stress model for understanding, predicting and treating emotional consequences of childhood cancer treatment. Intensive cancer treatment is intrusive and includes multiple and prolonged hospitalizations, repeated painful procedures, and generalized family distress over a period of several years. Four hundred pediatric oncology patients, age 8-18, disease free and off treatment for at least two years, and their parents, recruited from The Children's Hospital of Philadelphia and the University of California at Los Angeles will complete paper and pencil measures of anxiety, posttraumatic stress, social support, and family functioning. An interview measure of anxiety in children will be administered to a randomly selected subset of 125 subjects and their parents. Equivalent numbers of matched controls, recruited from the pediatric clinics at both centers, will be used as a comparison group for both paper and pencil and interview portions of the study. The presence of anxiety and specific post-traumatic stress symptoms in the sample of cancer survivors will be compared with that in the control group. The relationship of post-traumatic stress symptoms to intensity of treatment, medical sequelae of treatment, and family and social support variables in survivors will also be explored. Through the identification of the prevalence and correlates of anxiety in pediatric oncology survivors and their parents, interventions to remediate the associated distress can be designed.

In this proposal we outline a multidisciplinary educational intervention for staff, patients, and families of pediatric cancer patients which focuses on reducing pain and distress during medical procedures. The specific aims of the Analgesia Protocol for Procedures in Oncology (APPO) are to: (1). develop an integrated pharmacological/psychological protocol for procedures, following the recommendations of the Consensus Conference on the Management of Pain in Childhood Cancer; (2). expand education and interventions for families in assessing and coping with procedural pain and distress; (3). prepare and implement programs and materials for multidisciplinary education and involvement in pain management; (4). use quantitative methods to demonstrate the effectiveness of the protocol for staff, patients, and families, including research looking at the ways in which such programs can be implemented; and (5). disseminate the results of our work to staff, patients, and families, including hosting conferences on the use of the protocol and means of introducing APPO in other hospital and clinic settings. New pharmacological guidelines will be utilized for all patients. The APPO intervention (new guidelines plus family assessment and specialized intervention) will be introduced initially to all new patients with leukemia at The Children's Hospital of Philadelphia (N=48/year. Patients will be randomized to APPO (with an individualized psychological intervention plan) or the existing psychosocial services for the first year. In Years 2 and 3 all patients with leukemia and other pediatric cancers will be offered APPO. Multidisciplinary staff education will begin before the initiation of APPO, and continue over the three year period.

Increasingly aggressive medical treatment has resulted in a dramatic rise in the number of childhood cancer survivors over the past two decades. While "cured" of cancer, these children and adolescents are at risk for significant medical and psychological sequelae. In the present study, we propose and test a post-traumatic stress model for understanding, predicting and treating emotional consequences of childhood cancer treatment. Intensive cancer treatment is intrusive and includes multiple and prolonged hospitalizations, repeated painful procedures, and generalized family distress over a period of several years. Four hundred pediatric oncology patients, age 8-18, disease free and off treatment for at least two years, and their parents, recruited from The Children's Hospital of Philadelphia and the University of California at Los Angeles will complete paper and pencil measures of anxiety, posttraumatic stress, social support, and family functioning. An interview measure of anxiety in children will be administered to a randomly selected subset of 125 subjects and their parents. Equivalent numbers of matched controls, recruited from the pediatric clinics at both centers, will be used as a comparison group for both paper and pencil and interview portions of the study. The presence of anxiety and specific post-traumatic stress symptoms in the sample of cancer survivors will be compared with that in the control group. The relationship of post-traumatic stress symptoms to intensity of treatment, medical sequelae of treatment, and family and social support variables in survivors will also be explored. Through the identification of the prevalence and correlates of anxiety in pediatric oncology survivors and their parents, interventions to remediate the associated distress can be designed.

Our previous research on psychological sequelae of childhood cancer treatment indicates that symptoms of post traumatic stress are significant for many survivors and their mothers and fathers. Indeed, there are many aspects of cancer and its treatment which are potential traumatic stressors, including invasive medical procedures, life threat, and disruption of family relationships. These prior data support the importance of anxiety, beliefs about cancer and its treatment, social support and family functioning as both direct and indirect contributions to posttraumatic stress symptoms. This proposal expands research on child and family adjustment to long-term survival of childhood cancer by developing and examining an intervention for posttraumatic stress in childhood cancer survivors and their families. The intervention integrates cognitive behavioral and family intervention approaches for 11-18 year old adolescent survivors, at least one year from the completion of their cancer treatment, and their mothers and fathers, at The Children's Hospital of Philadelphia. Home-based pre (Time 1) and six-month post (Time 2) evaluations will be conducted. Families will be randomized to the intervention or wait list condition after Time 1. The wait list group will receive the intervention after Time 2. The intervention consists of two half-day weekend sessions, eight weeks apart, with the first half-day session focused individually on the recognition of the long-term psychological effects of cancer and its treatment and use of cognitive-behavioral strategies for reducing cancer-related distress, for survivors, mothers and fathers separately. The second half-day session is a family-oriented intervention directed towards helping families communicate more effectively about the impact of cancer and reframe the experiences for themselves as families. Eight families will participate in each intervention, for a total n of 128 families. Data analysis strategies address change in post traumatic stress symptoms with particular attention to anxiety, perceptions of life threat and perceived intensity of treatment, social support and family factors. To our knowledge, this project is unique in providing an empirical evaluation of an intervention combining cognitive behavioral and family intervention techniques to alleviate and prevent ongoing psychological distress in children who have survived cancer and their parents.

The diagnosis of children cancer affects the family and continues to impact parental functioning after treatment ends. Our previous research showed the persistence of parents' distressing symptoms of posttraumatic stress and its association with anxiety. In this proposal, we focus on the identification of parental beliefs associated with anxiety and adaption during treatment for childhood cancer, and conduct a randomized clinical trial (RCT) of a cognitive-behavioral and family therapy intervention for parents of newly diagnosed children with cancer. The three session intervention, Surviving Cancer Competently Intervention Program, Revised (SCCIP-R) is an adaptation of our intervention protocol for survivors of childhood cancer and their families. The first step in the project is the systematic identification of mothers' and fathers' beliefs about the disease and the treatment in a sample of 120 families of children in families at diagnosis of childhood cancer, randomized to SCCIP-R intervention or an attention control condition. Baseline, 2 and 6 month data collections will include self-report measures of parental anxiety, psychological adjustment and family. Child quality of life will be assessed by parent and staff report. We will determine the affects of parental anxiety and its reduction on the child's quality of life. In a subsample of 62 patients with acute lymphoblastic (ALL), we will examine the associations of parental anxiety with parental neuroendocrine makers (DHEA-S/cortosol ratio, ACTH, Substance P) and explore the associations among lowered levels of parental levels of parental anxiety and medical outcomes. Finally, we will assess the long- term impact of SCCIP-R assessing parental and patient posttraumatic stress at two points after cancer treatment ends. To our knowledge, this project is unique in providing a RCT of an intervention to reduce parental distress after diagnosis of childhood cancer and in the integration of neuroendocrine makers and medical outcome. If effective, SCCIP-R would provide evidence for the feasibility and importance of providing systemic intervention with families of patients with cancer.

DESCRIPTION (provided by applicant): While psychosocial services for children with cancer and their families are available in most cancer treatment centers, this care may be enhanced and delivered with greater effectiveness with systematic assessment instruments that can accurately identify risk factors for ongoing psychosocial adjustment or difficulties. We have developed and conducted a preliminary feasibility pilot study of a 20 item screening instrument, the Psychosocial Assessment Tool (PAT) for families of children newly diagnosed with cancer. The PAT includes questions for l 0 domains of risk, based on the research literature and clinical practice: Family Structure; Family Resources; Social Support; Child Knowledge; School; Child Emotional and Behavioral Concerns; Child Maturity for Age; Marital/Family Problems; Family Beliefs; and Other Stressors. In the present study we propose to develop scoring criteria for the PAT and to evaluate it by determining its psychometric properties (short-term and 6 month test-retest reliability and concurrent, construct, and predictive validity). 140 families of children newly diagnosed with cancer at The Children's Hospital of Philadelphia (CHOP) will be recruited and asked to complete the PAT and questionnaires assessing parental, child and family functioning at diagnosis and 6 months subsequently. Data will also be obtained from oncologist and nurse ratings of family risk and function. We will also measure hospital resource utilization (e.g., social work and psychological interventions, extent/intensity of nursing/medical attention to psychosocial issues, and use of other hospital resources). An external panel of multidisciplinary experts in pediatric oncology will assist in determining the scoring and weighting of items. Our hypotheses and related statistical analyses will test associations among parent and staff assessments of family risk and the predictive ability of the PAT to identify those families with ongoing psychosocial difficulty and elevated levels of resource utilization. The PAT is novel in its brief empirical approach to determining family risk in pediatric oncology. By reliably identifying families with varying levels of risk at diagnosis we may develop subsequent interventions which match their level of need over the course of treatment.

DESCRIPTION (provided by applicant): Appropriate care for long-term survivors of childhood cancer depends on understanding the psychology being a young adult long-term survivor, including psychosocial late effects, reactions to follow-up care, and predictors of distress and participation in health care. Although young adult cancer survivors have elevated rates of distress relative to norms, it is not known how their distress compares to that reported by a matched of never ill peers, or how other variables related to health care might be associated with distress. Beliefs about one's medical vulnerability and medical competence (health competence beliefs; HCB) are theoretically related to distress and to participation in health care, although these relationships have not been examined empirically with long-term survivors of childhood cancer. This study aims to examine these links. Aim 1 identifies distress that is cancer-specific by comparing long-term survivors of childhood cancer to a matched group of well individuals at the time of a medical visit and two months later. Aim 2 proposes to develop a reliable and valid brief screening tool of health competence beliefs (HCB) that are associated with distress. Aim 3 proposes to test the association among survivors HCB, health risk knowledge, psychological distress, and follow-up care. Analysis of existing data and focus groups of 8-12 long-term survivors will be used to develop the HCB measure. After pilot feasbility testing, 150 16-39 year old long-term survivors of childhood cancer and 300 never ill young adults will complete questionnaires assessing beliefs and distress at a routine follow-up/health maintenance medical visit, and two months later (by mail or Internet). Survivors will also complete the questionnaires 12 months later; medical late effect and treatment intensity will be rated and contact with the oncology medical team will be tracked over 12 months. The findings of this study are expected to inform the structure of follow-up visits by providing a tool to identify distressed survivors, as well as guidelines to optimize patients adaptive beliefs about their health competence, thereby maximizing long-term survivors' use of health care and enhancing their physical and psychological well-being.

DESCRIPTION (provided by applicant): Project Summary: This is an application for an Established Investigator Award in Cancer Prevention and Control (K05;PAR-05-145) for Anne E. Kazak, Ph.D., Professor, Department of Pediatrics at the University of Pennsylvania, based in the Division of Oncology at The Children's Hospital of Philadelphia. Dr. Kazak is a well established cancer investigator, with continuous federal funding since 1991. She has served as a research mentor to many multidisciplinary trainees, fellows and junior faculty, the majority now with academic positions and federally funded work. Dr. Kazak's work utilizes a social ecological framework to understand the adaptation of children with cancer and their families, with a particular focus on pediatric cancer survivorship. Her current research is focused on the development of evidence-based psychosocial interventions for children with cancer and their families, using two models that she has developed: 1) A posttraumatic stress model, viewing the diagnosis and treatment of cancer as potentially traumatic and persistent overtime;and 2) The Pediatric Preventative Psychosocial Health Model (PPPHM), a preventative public health oriented model to guide interventions for children with pediatric malignancies and their families. Dr. Kazak is pursuing this award in order to focus her efforts on mentoring and research. A plan for expanded mentoring is described, with multidisciplinary mentees and the development of mini-courses to attract and train more individuals in psychosocial research and interventions in pediatric cancer (and other serious pediatric illnesses). The application outlines two proposed studies. Project 1 investigates linkages between ongoing research on posttraumatic stress in young adult survivors and adherence to survivorship treatment recommendations. Project 2 extends Dr. Kazak's work on intervention development for families of patients newly diagnosed with cancer, requesting funds to pilot adaptations of the existing treatment model, with an emphasis on broader dissemination of this work. In sum, the proposal aims to increase the cadre of investigators conducting research on psychosocial aspects of cancer and contribute to Dr. Kazak's broad career goals of enhancing psychosocial intervention in pediatric oncology. Lay Summary: Dr. Kazak is an established investigator who studies psychological adjustment of children with cancer and their families. She has mentored many multidisciplinary trainees and junior faculty. In this application she presents a plan for expanded mentoring and two research projects related to her work on intervention development and dissemination.