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David Cella

Publications and source records attributed to David Cella.

118 records · Page 7Linked to original sources

Assessing quality of life in research and clinical practice.

There is a growing recognition in oncology of the importance of maintaining or improving patients' quality of life (QOL) throughout the disease course. With this goal in mind, many clinical trials in oncology now seek to evaluate QOL endpoints. In using QOL measures as research tools, investigators need to consider which instrument is best suited to addressing the issues under study, how often and when to administer the instrument, and how to deal with data that may be missing due to toxicity, morbidity, or mortality. Findings from QOL research can inform clinical care by providing information about the likely impact of disease and its treatment on functioning and wellbeing, identifying common problems, and developing effective interventions to deal with these problems. The routine assessment of QOL may also have clinical uses at the individual patient level. These uses include fostering patient-provider communication, identifying frequently overlooked problems, prioritizing problems, and evaluating the impact of palliative and rehabilitative efforts. Although several barriers exist to routine assessment of quality of life in clinical practice, several strategies can be used to successfully overcome these barriers.

Clinical Protocols↗

A brief assessment of concerns associated with genetic testing for cancer: the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire.

The Multidimensional Impact of Cancer Risk Assessment (MICRA) is a new tool to measure the specific impact of result disclosure after genetic testing. The authors compared its performance with that of questionnaires measuring general and cancer-specific distress. Participants (158 women) responded 1 month after they received genetic test results. The women were divided into 4 standard clinical test result groups: BRCA1/2 positive, BRCA1/2 negative, panel negative, and true negative. Factor analysis supported the formation of 3 subscales: Distress (6 items, alpha = .86), Uncertainty (9 items, alpha = .77), and Positive Experiences (4 items, alpha = .75). All 3 MICRA subscales differentiated participants who were BRCA1/2 positive from the other 3 groups. MICRA thus helps identify subgroups of vulnerable genetic testing participants.

Adult↗

Quality of life and symptom measures in oncology: an overview.

Improving quality of life (QOL) in oncology patients is an important therapeutic goal, and most treatment decisions are heavily influenced by their effect on QOL. Although measuring QOL has been a significant challenge because of a lack of consensus on the definition of QOL, research in this field has advanced rapidly. Numerous instruments now exist for measuring QOL and symptom burden, ranging from general health status measures to considerably more focused symptom measures. QOL measures have been routinely incorporated in clinical trials, and their use in clinical settings is strongly encouraged because their value in cancer patient management is now established. These measures also have a potential impact in the managed care environment because they provide information on patient satisfaction and quality of care provided. This article clarifies the definition of QOL, provides a brief overview of several useful measurement instruments, and addresses some common concerns encountered in measuring QOL in cancer patients. In addition, potential uses of such measures are explored and their value in various settings, including managed care, is highlighted.

Cost of Illness↗

Resilience, reflection, and residual stress in ovarian cancer survivorship: a gynecologic oncology group study.

Ovarian cancer is a life-threatening diagnosis which poses multiple challenges. The purpose of this study is to describe the quality of life (QOL) concerns and survivorship sequelae of long-term (>5 yr) early-stage ovarian cancer survivors accrued through the clinical cooperative Gynecologic Oncology Group. Forty-nine ovarian cancer survivors with a mean age at diagnosis of 55.9 yr (range 30-76) completed a telephone interview assessing QOL, psychosocial status, sexual functioning and late-effects of treatment. Results indicate that this disease-free early-stage sample enjoys a good QOL, with physical, emotional, and social well-being comparable to other survivors and same-aged noncancer cohorts. However, 20% of survivors indicated the presence of long-term treatment side effects, with a subset reporting problems related to abdominal and gynecologic symptoms, and neurotoxicity. Spiritual well-being was significantly positively associated with personal growth and mental health, and negatively associated with a declining health status. Lingering psychological survivorship sequelae included fear of follow-up diagnostic tests and fear of recurrence. Forty-three percent of respondents expressed that they would likely participate in a counseling program today to discuss psychosocial issues raised by having had ovarian cancer, and 56% stated that they would have attended a support program during the initial treatment if it had been offered. This information provides some insight into the complex survivorship relationships between quality of life, long-term physical and sexual sequelae, and factors of resilience and growth which appear to promote a sense of well-being as a result of the cancer experience.

Adaptation, Psychological↗

Randomized phase II trial of either fluorouracil, parenteral hydroxyurea, interferon-alpha-2a, and filgrastim or doxorubicin/docetaxel in patients with advanced gastric cancer with quality-of-life assessment: eastern cooperative oncology group study E6296.

PURPOSE: The Eastern Cooperative Oncology Group conducted a randomized phase II trial to determine the objective response rates, toxicities, and overall survival and to assess effects on quality of life for two combination regimens in patients with advanced gastric cancer. PATIENTS AND METHODS: All patients had biopsy-proven, untreated metastatic gastric cancer with measurable disease. The FHIG arm employed infusional fluorouracil (F), 2.6 g/m2, given intravenously over 24 hours once perweek for 6 weeks; infusional hydroxyurea (H), 4.3 g/m2, given intravenously over 24 hours once per week for 6 weeks; and interferon-alpha-2a (1), 9 MU given subcutaneously three times per week, once per week for 6 weeks. The AD arm employed doxorubicin (A), 50 mg/m2, and docetaxel (D), 75 mg/m2, both given intravenously every 21 days. Quality of life was measured by the FACT-Fatigue scale and a novel questionnaire assessing interferon-mediated fatigue. RESULTS: Twenty-nine patients were enrolled; 23 were eligible and evaluable. Twelve were enrolled on FHIG and 11 on AD. The major grade > or = 3 toxicities were neuromotor (46%) in patients receiving FHIG and granulocytopenia (91%) in those receiving AD. There were two fatalities in the AD arm. There was one partial responder on FHIG (8.3%) and none on AD. The median survival was 6.6 months for FHIG and 10.1 months for AD. Quality-of-life analysis did not show substantial cumulative fatigue in patients treated with FHIG. CONCLUSIONS: Neither regimen demonstrated enough activity to serve as a platform for the development of further clinical regimens against gastric carcinoma. A subset of patients receiving interferon was able to tolerate therapy without deterioration in quality of life.

Adult↗

Using multiple anchor- and distribution-based estimates to evaluate clinically meaningful change on the Functional Assessment of Cancer Therapy-Biologic Response Modifiers (FACT-BRM) instrument.

OBJECTIVE: The interpretation of health-related quality of life (HRQL) data from clinical trials can be enhanced by understanding the degree of change in HRQL scores that is considered meaningful. Our objectives were to combine distribution-based and two anchor-based approaches to identify minimally important differences (MIDs) for the 27-item Trial Outcome Index (TOI), the seven-item Social Well-Being (SWB) subscale, and the six-item Emotional Well-being (EWB) subscale from the Functional Assessment of Cancer Therapy-Biological Response Modifiers (FACT-BRM) instrument. METHODS: Distribution-based MIDs were based on the standard error of measurement. Anchor-based approaches utilized patient-reported global rating of change (GRC) and change in physician-reported performance status rating (PSR). Correlations and weighted kappa statistics were used to assess association and agreement between the two anchors. FACT-BRM changes were evaluated for three time periods: baseline to month 1, month 2 to month 3, and month 5 to month 6. RESULTS: Association between GRC and change in PSR was poor. Correlation between the anchors and HRQL change scores was largest at month 1 and decreased through month 6. Combining results from all approaches, the MIDs identified were 5-8 points for the TOI, 2 points for the SWB subscale, and 2-3 points for the EWB subscale. CONCLUSIONS: We combined patient-reported estimates, physician-reported estimates, and distribution-based estimates to derive MIDs for HRQL outcomes from the FACT-BRM. These results will enable interpretation of treatment group effects in a clinical trial setting, and they can be used to estimate sample size or power when designing future studies.

Adolescent↗

Are inflammatory cytokines the common link between cancer-associated cachexia and depression?

The prevalence of depression among patients diagnosed with cancer is higher than among the general medical population and is associated with faster tumor progression and shortened survival time. Cancer-related depression often occurs in association with anorexia and cachexia, although until recently the relationship between these conditions has not been well understood. Cachexia is associated with poorer quality of life and survival outcomes and is theeventual cause of death in approximately 30% of all patients with cancer. Recent evidence has linked elevated levels of inflammatory cytokines with both depression and cachexia, and experiments have shown that introducing cytokines induces depression and cachectic symptoms in both humans and rodents, suggesting that there may be a common etiology at the molecular level. Therapeutic agents targeting specific cytokine molecules, such as interleukin-6 or tumor necrosis factor-alpha, are currently being evaluated for their potential to simultaneously treat both depression and cachexia pharmacologically. This review summarizes the available data suggesting a dual role for cytokines in the development of cancer-related depression and cachexia and describes how biologic therapies targeting specific cytokines may improve outcomes beyond depression and cachexia, such as survival and quality of life.

Animals↗

Measuring quality of life in patients with melanoma: development of the FACT-melanoma subscale.

A systematic review of the literature on quality of life (QOL) in melanoma patients suggested an overwhelming need for a disease-specific subscale. A melanoma subscale for the Functional Assessment of Cancer Therapy (FACT-Melanoma) was developed to meet this need. This instrument was developed in three stages. In stage I, the literature was comprehensively reviewed, and over 300 cancer-specific items from the Functional Assessment of Chronic Illness Therapy (FACIT) item bank were examined to identify questions of potential relevance to melanoma patients. In stage II, 20 melanoma experts identified questions that were relevant to melanoma patients and that were to be included in a pilot questionnaire. In stage III, the pilot questionnaire and a semistructured interview to assess item comprehension, relevance, and overall content were administered to 40 patients with various stages of melanoma. In all, 97 items were culled from the literature and the FACIT item bank; after items were reviewed and evaluated, 25 questions were retained. Most patients considered the content of the pilot questionnaire to be relevant (95%), comprehensive (60%), and easy to understand (88%). After final revisions were made, the FACT-Melanoma tool included 24 items encompassing three QOL domains: 20 items relate to physical well-being, 3 to emotional well-being,and 1 to social well-being. The face and content validity of the FACT-Melanoma assessment tool has been confirmed in melanoma patients and by professionals. Formal validation and reliability testing of the questionnaire is being determined in a prospective cohort of melanoma patients.

Adult↗