Carolyn C. Gotay

Assessment of Survivor Concerns (ASC): A newly proposed brief questionnaire

BackgroundThe purpose of this study was to design a brief questionnaire to measure fears about recurrence and health in cancer survivors. Research involving fear of recurrence has been increasing, indicating that it is an important concern among cancer survivors.MethodsWe developed and tested a six-item instrument, the Assessment of Survivor Concerns (ASC). Construct validity was examined in a multiple group confirmatory factor analysis (CFA) with 592 short-term and 161 long-term cancer survivors. Convergent and discriminant validity was examined through comparisons with the PANAS (Positive and Negative Affect Schedule) and the CES-D (Center for Epidemiologic Studies Depression) measures.ResultsCFA models for the ASC with short- and long-term survivors showed good fit, with equivalent structure across both groups of cancer survivors. Convergent and discriminant validity was also supported through analyses of the PANAS and CES-D. One item (childrens health worry) did not perform as well as the others, so the models were re-run with the item excluded, and the overall fit was improved.ConclusionThe ASC showed excellent internal consistency and validity. We recommend the revised five-item instrument as an appropriate measure for assessment of cancer survivor worries.

Assessment of quality of life in a multicultural cancer patient population.

Quality of life (QOL) is increasingly assessed in cancer patients. In this article, the authors examined the psychometric performance of a commonly used QOL questionnaire, the Quality of Life Questionnaire--Cancer 30 (QLQ-C30; N. K. Aaronson et al., 1993), in multiethnic cancer patients. Content validation studies in patients and clinicians identified possible new items. Multiple-group confirmatory factor analysis supported equivalent structure across ethnic groups (Caucasians and Asian/Pacific Islanders [APIs]). A higher order QOL factor appeared to directly affect functioning scales and symptom count. Exploratory factor analysis examined effects of new items. Ten factors were extracted, 6 consistent with the original instrument and 4 reflecting potentially new aspects of QOL: Positive Social Support, Coping, Existential Well-Being, and Sexuality/Intimacy. The QLQ-C30 appears appropriate for use in API cancer patients. Further work needs to ensure that it includes all important domains.

Ethnic differential item functioning in the assessment of quality of life in cancer patients

BackgroundPast research has shown that Filipino cancer patients report lower levels of quality of life (QoL) than other ethnic groups. One possible explanation for this is that Filipinos do not define QoL in the same manner as others, resulting in bias in their assessments. Hence, Filipinos would not necessarily have lower QoL.MethodsItem response theory methods were used to assess differential item functioning (DIF) in the quality of life (measured by the EORTC QLQ-C30) of cancer patients across four ethnic groups (Caucasian, Filipino, Hawaiian, and Japanese). The sample consisted of 359 cancer patients.ResultsResults showed the presence of DIF on several items, indicating ethnic differences in the assessment of quality of life. Relative to the Caucasian and Japanese groups, items related to physical functioning, cognitive functioning, social functioning, nausea and vomiting, and financial difficulties exhibited DIF for Filipinos. On these items Filipinos exhibited either higher or lower QoL scores, even though their overall QoL was the same.ConclusionThis evidence may explain why Filipinos have previously been found to have lower overall QoL. Although Filipinos score lower on QoL than other groups, this may not reflect lower QoL, but rather differences in how QoL is defined. The presence of DIF did not appear, however, to alter the psychometric properties of the QLQ-C30.

Outcomes Assessment in Cancer: Introduction to Outcomes Assessment in Cancer

ion, and table construction, as discussed below. The process of report generation and chapter preparation was an iterative one: research, initial manuscript drafts, group discussions, electronic communicationbetweeneditors and authors, revision and re-revision, and final editing. The three working group meetings (February 2001, December 2001, and December 2002) provided important opportunities for presentations, panel discussions, andsmall-groupsessions. Inaddition,eachCOMWG member was assigned to an “affinity group” consisting of COMWGmembers with allied methods or application interests, in order to promote interdisciplinary peer review and discussion. Throughout the period from early 2001 until the final assigned chapter was completed in 2004, the editors had both the responsibility and the remarkable opportunity to work closely with the other 32members of theCOMWG in anumber of respects. Beyond the initial designation of topic areas, this involvedtailoringquestionsets inresponse toauthor suggestions, reviewing chapter drafts, and working interactively through the multi-step review and editing process that led to the chapters found here.

Complementary and alternative medicine use and breast cancer prognosis: a pooled analysis of four population-based studies of breast cancer survivors.

BACKGROUND Complementary and alternative medicine (CAM) use is common among breast cancer survivors, but little is known about its impact on survival. METHODS We pooled data from four studies conducted in Hawaii in 1994-2003 and linked to the Hawaii Tumor Registry to obtain long-term follow-up information. The effect of CAM use on the risk of breast cancer-specific death was evaluated using Cox regression. RESULTS The analysis included 1443 women with a median follow-up of 11.8 years who had a primary diagnosis of in situ and invasive breast cancer. The majority were Japanese American (36.4%), followed by white (26.9%), Native Hawaiian (15.9%), other (10.6%), and Filipino (10.3%). CAM use was highest in Native Hawaiians (60.7%) and lowest in Japanese American (47.8%) women. Overall, any use of CAM was not associated with the risk of breast cancer-specific death (hazard ratio [HR] 1.47, confidence interval [CI] 0.91-2.36) or all-cause death (HR 0.82, 95% CI 0.63-1.06). However, energy medicine was associated with an increased risk of breast cancer-specific death (HR 3.19, 95% CI 1.06-8.52). When evaluating CAM use within ethnic subgroups, Filipino women who used CAM were at increased risk of breast cancer death (HR 6.84, 95% CI 1.23-38.19). CONCLUSIONS Our findings suggest that, overall, CAM is not associated with breast cancer-specific death but that the effects of specific CAM modalities and possible differences by ethnicity should be considered in future studies.

Factors Affecting Survival Among Women with Breast Cancer in Hawaii

BACKGROUND Given previous reports of ethnic differences in breast cancer survival among Hawaiis population, we investigated the role of adherence to treatment standards, treatment toxicity, preexisting chronic conditions, and obesity in the survival of 382 prospectively studied breast cancer patients representing six ethnic groups. METHODS Participants were recruited from several hospitals in Honolulu. Information on tumor characteristics and treatment was abstracted from medical records. Based on the Physicians Data Query (PDQ®), we assessed compliance with recommended treatment guidelines. Vital status and cause of death data were obtained through linkage with the Hawaii Tumor Registry. Cox proportional hazard models were used to compute hazard ratios for predictors of survival. RESULTS After a median follow-up time of 13.2 ± 3.7 years, 115 deaths had occurred, 43 from breast cancer and 72 from other causes. After adjustment, we observed only small differences in survival by ethnicity that were not statistically significant. In addition to advanced disease stage, obesity at diagnosis was a significant independent predictor of worse and receiving PDQ-recommended treatment of better breast cancer-specific and all-cause survival. Developing high-grade toxicity was associated with worse breast cancer survival, whereas comorbidity and older age at diagnosis were associated with higher all-cause mortality. Hormone receptor status, menopausal status, and type of health insurance were not associated with survival. CONCLUSIONS These findings suggest that given access to healthcare, breast cancer patients experience similar survival rates. Although more information about mechanisms of action would be useful, it appears reasonable to recommend weight control to breast cancer survivors.

Using Quality of Life Measures in a Phase I Clinical Trial of Noni in Patients With Advanced Cancer to Select a Phase II Dose

ABSTRACT. The purpose of this study was to determine a maximum tolerated dose of noni in cancer patients and whether an optimal quality of life-sustaining dose could be identified as an alternative way to select a dose for subsequent Phase II efficacy trials. Dose levels started at two capsules twice daily (2 g), the suggested dose for the marketed product, and were escalated by 2 g daily in cohorts of at least five patients until a maximum tolerated dose was found. Patients completed subscales of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 quality of life (physical functioning, pain, and fatigue) the brief fatigue inventory (BFI), questionnaires at baseline and at approximately 4-week intervals. Blood and urine were collected at baseline and at approximately 4-week intervals for measurement of scopoletin. Fifty-one patients were enrolled at seven dose levels. The maximum tolerated dose was six capsules four times daily (12 g). Although no dose-limiting toxicity was found, seven of eight patients at the next level (14 g), withdrew due to the challenges of ingesting so many capsules. There were dose-related differences in self-reported physical functioning and pain and fatigue control. Overall, patients taking three or four capsules four times daily experienced better outcomes than patients taking lower or higher doses. Blood and urinary scopoletin concentrations related to noni dose. We concluded that it is feasible to use quality of life measures to select a Phase II dose. Three or four capsules four times daily (6–8 g) is recommended when controlling fatigue, pain, and maintaining physical function are the efficacies of interest. Scopoletin, a bioactive component of noni fruit extract, is measurable in blood and urine following noni ingestion and can be used to study the pharmacokinetics of noni in cancer patients.