Showing papers by "Carolyn C. Gotay published in 2008"

The Prognostic Significance of Patient-Reported Outcomes in Cancer Clinical Trials

Abstract: Purpose Patient-reported outcomes (PROs), routinely collected as a part of cancer clinical trials, have been linked with survival in numerous clinical studies, but a comprehensive critical review has not been reported. This study systematically assessed the impact of PROs on patient survival after a cancer diagnosis within the context of clinical trials. Design Cancer clinical trials that assessed baseline PROs and mortality were identified through MEDLINE (through December 2006) supplemented by the Cochrane database, American Society of Clinical Oncology/European Society for Medical Oncology abstracts and hand searches. Inclusion criteria were publication in English language and use of multivariate analyses of PROs that controlled for one or more clinical factors. Two raters reviewed each study, abstracted data, and assessed study quality; two additional raters verified abstractions. Results In 36 of 39 studies (N = 13,874), at least one PRO was significantly associated with survival (P < .05) in multiva...

Development of a Family Intervention for Native Hawaiian Women with Cancer: A Pilot Study

Abstract: Native Hawaiian women have high cancer rates and low survival rates. As with other women, a major source of support for Native Hawaiian women is their families. This pilot study reports on the feasibility of providing and measuring a culturally appropriate intervention designed to help Native Hawaiian women and their families deal with cancer. The feasibility evaluation indicated that a major strength of the intervention was its incorporation of Hawaiian values and practices, and a major limitation reflected the difficulties in recruiting Native Hawaiians for research studies. Despite the small sample size, the six Native Hawaiian women and their 10 family members in the intervention group showed improved self-efficacy and coping when compared with the four Native Hawaiian women and their eight family members in the control group. Pilot study data established the feasibility and potential effectiveness of this culturally tailored intervention for Native Hawaiians, and feasibility findings will be useful in designing follow-up studies. Steps taken to incorporate cultural values into an intervention also provide a model for other social workers in developing culturally appropriate interventions for minority populations.

Prognostic factor analysis of health-related quality of life data in cancer: a statistical methodological evaluation.

Abstract: A significant body of research exists in oncology to identify and evaluate prognostic factors, historically focused on histology, clinical stage and laboratory parameters. Recent evidence suggests that patient self-reported health-related quality-of-life (HRQOL) data provide additional prognostic information. A review by Gotay et al. of published prognostic analyses reports on the usefulness of patient-reported outcomes (PROs), including HRQOL, in predicting survival in cancer patients in clinical trials. An impressive number of studies have found a positive relationship that supports an independent association between HRQOL and survival. However, due to the considerable diversity in, for example, patient groups, types of HRQOL measures used and analytical strategies, current evidence is far from conclusive. This paper examines the statistical research methods employed, discusses key issues for HRQOL prognostic factor-analysis parameters and proposes recommendations for future outcome research.

Adaptation and quality of life among long-term cervical cancer survivors in the military health care system.

Abstract: Objective: This study assessed quality of life in long-term cervical cancer survivors eligible for health care in the military health system. Methods: TRICARE beneficiaries who were diagnosed as having cervical cancer in 1980 to 2000 completed self-administered questionnaires including standardized measures of quality of life, distress, and sexuality. Results: Forty-one women (72% of those who received questionnaire packets) provided questionnaire data. More than 2,500 questionnaires were undeliverable, with no forwarding address. Data indicated that quality of life, cervical cancer-related stress, and intimacy concerns were comparable to population normative values. Survivors received more cancer screenings than the general population. Nearly one-half of respondents reported no effect of cancer on their sexual relationships, whereas approximately one-half said that cancer had a negative impact. Conclusions: Although cervical cancer survivors overall reported a high quality of life, many experien...

Social Psychological Factors in Placebo-Controlled Clinical Trials

Abstract: In this issue of the Journal of Clinical Oncology, Daugherty et al have provided elegant and thoughtful reasoning to identify the circumstances under which placebos may be acceptable, or even advisable, in cancer clinical trials. Although the scientific concerns they so skillfully elucidate provide a guide for clinical trial design, additional considerations are likely to affect the successful completion of clinical trials that include placebos. The social psychology of the clinical trials process is important to consider when it comes to the acceptability and use of such trials. Social psychological factors include individual and social influences on behavior, some of which will be discussed further: public perceptions, patient and oncologist preferences, and patient communication.