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K Ruccione

Publications and source records attributed to K Ruccione.

At least 19 recordsLinked to original sources
PubMed2004

Staged informed consent for a randomized clinical trial in childhood leukemia: impact on the consent process.

BACKGROUND: Children Cancer Group (CCG) 1991 is the first childhood acute lymphoblastic leukemia trial within CCG that allowed the utilization of a staged approach to the consent process. METHODS: One hundred and forty subjects participated in the Project on Informed Consent which compared the primary outcome measures in the consent process of patients enrolled in CCG-1991 with those enrolled in other CCG leukemia studies. RESULTS: The parents' trust scores were higher for the CCG-1991 compared with other protocols. Eighty percent of parents enrolled in CCG-1991 understood the distinction between the randomized clinical trial and the standard treatment arm, compared with 62.5% in the other studies, P = 0.05. Multiple other outcome measures suggested a positive impact from staged informed consent. CONCLUSIONS: Our results suggest that a consent process with a staged approach can help investigators obtain a more truly informed consent. Future research is needed to confirm the benefits of the staged approach to the informed consent process.

Child↗
PubMed2001

Late mortality experience in five-year survivors of childhood and adolescent cancer: the Childhood Cancer Survivor Study.

PURPOSE: Survivors of childhood and adolescent cancer are at risk for long-term effects of disease and treatment. The Childhood Cancer Survivor Study assessed overall and cause-specific mortality in a retrospective cohort of 20,227 5-year survivors. PATIENTS AND METHODS: Eligible subjects were individuals diagnosed with cancer (from 1970 to 1986) before the age of 21 who had survived 5 years from diagnosis. Underlying cause of death was obtained from death certificates and other sources and coded and categorized as recurrent disease, sequelae of cancer treatment, or non-cancer-related. Age and sex standardized mortality ratios (SMRs) were calculated using United States population mortality data. RESULTS: The cohort, including 208,947 person-years of follow-up, demonstrated a 10.8-fold excess in overall mortality (95% confidence interval, 10.3 to 11.3). Risk of death was statistically significantly higher in females (SMR = 18.2), individuals diagnosed with cancer before the age of 5 years (SMR = 14.0), and those with an initial diagnosis of leukemia (SMR = 15.5) or CNS tumor (SMR = 15.7). Recurrence of the original cancer was the leading cause of death among 5-year survivors, accounting for 67% of deaths. Statistically significant excess mortality rates were seen due to subsequent malignancies (SMR = 19.4), along with cardiac (SMR = 8.2), pulmonary (SMR = 9.2), and other causes (SMR = 3.3). Treatment-related associations were present for subsequent cancer mortality (radiation, alkylating agents, epipodophyllotoxins), cardiac mortality (chest irradiation, bleomycin), and other deaths (radiation, anthracyclines). No excess mortality was observed for external causes (SMR = 0.8). CONCLUSION: While recurrent disease remains a major contributor to late mortality in 5-year survivors of childhood cancer, significant excesses in mortality risk associated with treatment-related complications exist up to 25 years after the initial cancer diagnosis.

Adolescent↗
PubMed2001

Posttraumatic stress, quality of life, and psychological distress in young adult survivors of childhood cancer.

PURPOSE/OBJECTIVES: To explore the relationship between posttraumatic stress disorder (PTSD) and quality of life (QOL)/psychological outcome in young adult survivors of childhood cancer. DESIGN: Cross-sectional, descriptive study. SETTING: A large comprehensive pediatric cancer center on the West Coast. SAMPLE: Fifty-one young adult survivors of childhood cancer, 18-37 years of age, disease free, and off treatment for an average of 11 years (range 2.8-26.7 years). METHODS: A structured clinical interview was used to establish a PTSD diagnosis. Self-report instruments were used to assess QOL (RAND SF-36) and psychological distress (Brief Symptom Inventory (BSI)). Survivors with and without PTSD were compared on the BSI and RAND SF-36. MAIN RESEARCH VARIABLES: PTSD status, QOL and psychological distress. FINDINGS: Eleven subjects (20%) met full criteria for PTSD. Significant group differences were found for 17 of the 18 outcome variables. Survivors with PTSD reported clinically significant levels of psychological distress, whereas symptom levels for those without PTSD fell well within population norms. On all domains, QOL scores were significantly lower for the PTSD group compared to the non-PTSD group. CONCLUSIONS: PTSD in survivors of childhood cancer is related to long-term outcome. PTSD is associated with a poorer QOL (physical and mental) and an increase in psychological distress. Data suggest that survivors with PTSD have significant functional limitations and psychological comorbidity. IMPLICATIONS FOR NURSING PRACTICE: Screening cancer survivors for PTSD will identify high-risk patients who need further evaluation and intervention.

Adolescent↗
PubMed2000

Symptoms of posttraumatic stress in young adult survivors of childhood cancer.

PURPOSE: This study assessed the prevalence of posttraumatic stress symptoms in young adult survivors of childhood cancer and the association of posttraumatic stress with anxiety, adjustment, perceptions of illness and treatment, and medical data extracted from oncology records. PATIENTS AND METHODS: Seventy-eight young adults (ages 18 to 40 years) who had been treated for childhood cancer completed questionnaires and psychiatric interviews assessing posttraumatic stress, anxiety, perceptions of their illness and treatment, and symptoms of psychologic distress. Data on treatment intensity and severity of medical late effects were collected via chart review. RESULTS: Of the patient sample, 20.5% met American Psychiatric Association Diagnostic and Statistical Manual criteria for posttraumatic stress disorder (PTSD) at some point since the end of their treatment. Clinically significant levels of intrusive (9%) and avoidant (16.7%) symptoms were reported. Participants also reported elevated state and trait anxiety. Participants with PTSD reported higher perceived current life threat, more intense treatment histories, and higher (and clinically significant) levels of psychologic distress than those who did not have PTSD. CONCLUSION: One-fifth of this sample of young adult survivors of childhood cancer met criteria for a diagnosis of PTSD, with clinically significant symptoms of intrusion and avoidance reported. As in other samples, PTSD in young adult survivors was associated with anxiety and other psychologic distress. Survivors' perceptions of treatment and its effects were more highly associated with posttraumatic stress than were more objective medical data. The data suggest that cancer-related posttraumatic stress may emerge in young adulthood and may affect the achievement of developmental milestones and orientation toward health care.

Adolescent↗
PubMed2000

Pediatric oncology nursing in cooperative group clinical trials comes of age.

OBJECTIVES: To provide a review of the nursing committees in both the Children's Cancer Group and the Pediatric Oncology Group and discuss intergroup nursing research collaboration in preparation for the merger of these cooperative clinical trials groups. DATA SOURCES: Review articles, reports, and newsletters from cooperative clinical trials groups. CONCLUSIONS: Nurses have established a vital presence in the pediatric cancer cooperative groups over the past 20 years through education, clinical practice, and collaborative research. IMPLICATIONS FOR NURSING PRACTICE: With the unification of the pediatric cooperative groups into the single Children's Oncology Group, the time is uniquely right to build a program of nursing research allied with pediatric oncology cooperative group clinical trials.

Adolescent↗
PubMed1999

Cancer and genetics: what we need to know now.

Profound changes brought about by discoveries in molecular biology may enable us in the future to treat cancer without causing late effects or to prevent cancer altogether. Even before that happens, the age of molecular medicine has arrived. Molecular biology is the study of biological processes at the level of the molecule. A major aspect of molecular biology is molecular genetics--the science that deals with DNA and RNA. Most of the progress in molecular biology has been made in the second half of the 20th century. Each discovery or technological innovation has built on previous discoveries and paved the way for the next, culminating in the current effort to map, sequence, and understand the functions of the entire human genome. In the past 20 years, many pieces of the cancer puzzle have been found, showing us how the normal cellular control mechanisms go awry to cause cancer and setting the stage for genetic testing and disease treatment. These new discoveries bring both promise and peril. To provide comprehensive care for survivors of childhood cancer and care in other settings as well, health care providers must now be familiar with the concepts and language of molecular biology, understand its applications to cancer care, and be fully informed about its implications for clinical practice, research, and education.

Child↗
PubMed1998

Informed consent in the Childrens Cancer Group: results of preliminary research.

BACKGROUND: Informed consent is critical to the ethical conduct of pediatric cancer clinical research. Research regarding such consent has been limited. METHODS: After conducting a background survey of institutional practice from principal investigators (PIs) at 113 Childrens Cancer Group (CCG) centers, the authors obtained more detailed data regarding informed consent from 23 parents of children recently enrolled in CCG research trials and from 23 clinician-investigators at 5 CCG institutions. RESULTS: Approximately 73% of PIs responded to the background survey, providing context in which to interpret the more detailed information. Parents reported that they found the informed consent process helpful, although somewhat confusing. Satisfaction with informed consent was not related to ethnicity or education level. Parents found discussion with staff more helpful than the consent document, and the majority reported that the amount of information conveyed was appropriate. Although only 3 parents (13%) reported that too much information was given, nearly 50% of the investigators believed too much information usually is provided. All investigators believed that patients benefit from participation in CCG studies; the majority recommend that the child be enrolled on study, and the majority believe the major obstacle to good informed consent is parents' "state of shock." CONCLUSIONS: Parents expressed general satisfaction with the consent process. By contrast, clinician responses indicate dissatisfaction with the informed consent process. Future research must include more centers and larger numbers of parents of children who we enrolled as well as those who declined to participate in CCG studies, examine consent in minority subgroups, and further investigate the role of clinician-investigators and their interaction with parents and children during the informed consent process.

Adult↗
PubMed1997

High birth weight and risk of specific childhood cancers: a report from the Children's Cancer Group.

OBJECTIVES: High birth weight has been associated with a number of childhood cancers. This study was conducted to test the hypothesis that elevated birth weight is associated with an increased risk of diagnosis-specific and age-specific groups of childhood cancers. METHODS: A case-control study, using a large Children's Cancer Group database, examined birth weight as a risk factor for childhood cancer. Birth weight information for the index child was available for 3711 cases and 816 control subjects. RESULTS: There was a statistically significant increased risk of acute lymphoblastic leukemia, Wilms' tumor, and neuroblastoma with increasing birth weight (p, trend = 0.006, 0.003, and 0.001, respectively). A statistically significant decreased risk of cancer was observed for soft tissue sarcoma (p, trend = 0.04). When data were stratified on the basis of age at diagnosis, many of these associations were apparent for children whose disease was diagnosed before the age of 2 years. Moreover, for acute myeloid leukemia, age at diagnosis was an important effect modifier. For children with acute myeloid leukemia whose disease was diagnosed before 2 years of age, there was a statistically significant increased risk with high birth weight (odds ratio = 2.5, 95% confidence interval 1.1 to 5.5); there was no increased risk of acute myeloid leukemia with high birth weight noted for children whose disease was diagnosed after 2 years of age (odds ratio 1.3, 95% confidence interval 0.8 to 2.2). CONCLUSIONS: Biologic studies are needed to address why high birth weight may increase risk (particularly at younger ages) of development of certain cancers.

Birth Weight↗
PubMed1995

History of maternal fetal loss and increased risk of childhood acute leukemia at an early age. A report from the Childrens Cancer Group.

BACKGROUND: Maternal reproductive history of fetal loss previously has been reported to be associated with an increased risk of leukemia in subsequent offspring. Data from a Childrens Cancer Group (CCG) case-control study were analyzed to test the hypothesis that this association was dependent on the number of previous fetal losses and age at leukemia diagnosis. METHODS: A case-control study using a large Childrens Cancer Group database examined maternal history of fetal loss as a risk factor for childhood leukemia in subsequent offspring. One thousand seven hundred fifty-three patients with childhood acute leukemia were compared with 839 community control subjects s and 2081 nonleukemia cancer control subjects. RESULTS: A modest increase in risk was found to be associated with a history of fetal loss. Stratification by age at diagnosis of leukemia showed that this association was significant only for those patients diagnosed before 4 years of age and most significant in those patients diagnosed before 2 years of age. When comparing community controls with patients acute lymphocytic leukemia diagnosed before 2 years of age, one previous fetal loss was associated with a five-fold increased risk (P < 0.001) whereas two or more fetal losses were associated with a relative risk of 24.8 (P < 0.001). Similarly, patients with acute myelocytic leukemia diagnosed before 2 years of age demonstrated 5-fold and 12-fold increased risks associated with the previous fetal loss and 2 or more previous fetal losses, respectively. CONCLUSIONS: Childhood acute leukemia occurring at younger ages may be associated with an underlying genetic abnormality or chronic environmental exposure, which can be either lethal to the developing fetus or mutagenic and result in the development of acute leukemia.

Abortion, Spontaneous↗
PubMed1994

Epidemiological characteristics of childhood acute lymphocytic leukemia. Analysis by immunophenotype. The Childrens Cancer Group.

While a number of epidemiological studies of childhood acute lymphocytic leukemia (ALL) have been conducted, separate analysis of risk factors for ALL subtypes has generally not been possible. We report the results of an analysis of data obtained from parents of children with ALL (and a control group of children without cancer), linked to a clinical database. Cases were classified into four ALL subtypes, and odds ratios (OR) were determined for each subtype for a broad range of factors. Numerous significant associations were found, some across all subtypes and others that were subtype-specific. Factors with elevated and/or significant ORs included: (i) for common ALL (n = 286): Down syndrome; family history (FH) of bone/joint diseases; postnatal jaundice; birthweight; MMR vaccination; exposure to gases and insecticides; and parental occupational exposure to insecticides. (ii) for pre-B ALL (n = 38): FH of gastrointestinal, hematological or bone/joint diseases, or allergy; cat ownership; exposure to solvents, fumes, petroleum products, cleaning agents and farm animals; and parental exposure to farm animals, fumes and solvents; (iii) for T-cell ALL (n = 158): FH of gastrointestinal disorders, maternal age, male gender, and parental occupational exposure to metals; (iv) for null-cell ALL (n = 65): FH of congenital heart disorders; measles; and parental occupational exposure to fumes, metals or solvents. This analysis should be considered as a hypothesis-generating process for future case-control interview studies.

Adolescent↗
PubMed1992

Educational, occupational, and insurance status of childhood cancer survivors in their fourth and fifth decades of life.

PURPOSE: Survivors of childhood cancer who are now greater than or equal to 30 years of age are available for study in significant numbers for the first time. An evaluation of their educational achievement, current employment status, frequency of problems in the work-place, and ability to obtain affordable health and life insurance was the aim of this study. PATIENTS AND METHODS: This was a case-control study of 219 childhood cancer survivors with individually matched controls from two tertiary-care pediatric centers. Telephone interviews were used and drew on a 356-item basic instrument for both subjects and controls. Medical (including intensity of therapy), marital, and psychosocial areas were included in the survey, but statistical comparisons concentrated on educational and economic issues. RESULTS: The overall current status of survivors and controls in the relevant areas, ie, education, employment, and insurance, was similar. A history of employment discrimination for entry into the uniformed services and in other special situations, and life insurance discrimination during the initial years after the completion of therapy was noted. Survivors experienced few problems in the work-place. Survivors of CNS tumors were unique, with problems in many of the areas studied, although there were notable individual exceptions. CONCLUSION: With the exception of those individuals with CNS tumor histories, survivors who were treated in the era of 1945 to 1975 had few economic sequelae of cancer or its therapy that extended beyond the first decades after treatment.

Adult↗
PubMed1991

Informed consent for treatment of childhood cancer: factors affecting parents' decision making.

Both the treatment for childhood cancer and the legal requirements for gaining parents' consent to treatment have become increasingly complex. The purpose of the exploratory investigation reported here was to identify influential circumstances surrounding the consent process in the pediatric setting, to describe the relationship of parental anxiety to these factors, and to delineate related practice and research implications. Twenty-eight parents of children entered on one of four protocols for the treatment of newly diagnosed acute lymphoblastic leukemia at the Childrens Hospital Los Angeles and the University of California San Francisco were asked to complete two questionnaires within 48 hours after consenting to treatment: the State-Trait Anxiety Index and the Parent Informed Consent Questionnaire. Results of the study confirmed clinical experience that parents are given complex information and asked to make decisions about their child's life in a highly anxious state. Although participants were generally satisfied with the informed consent process 48 hours after signing a consent form, further research is needed to document how well parents understand and remember key information, as well as the influence of time, experience, and changes in state anxiety on their perceptions of the adequacy of the consent process. In current clinical practice, simple strategies can be applied to improve the informed consent process for families of children with cancer.

Adult↗