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Biomedical subjects

S Fleishman

Publications and source records attributed to S Fleishman.

9 recordsLinked to original sources
PubMed2004

L-carnitine supplementation for the treatment of fatigue and depressed mood in cancer patients with carnitine deficiency: a preliminary analysis.

Nutritional factors are among the postulated causes of fatigue, a highly prevalent symptom in the cancer population, with serious impact on patients' quality of life. Deficiency of the micronutrient carnitine may play a role by reducing energy production through fatty acid oxidation. We present preliminary data of an open-label, dose-finding study to determine safety and maximally tolerated dose (MTD) of 1 week of L-carnitine supplementation in cancer patients with fatigue and carnitine deficiency. Patients who met inclusion/exclusion criteria underwent carnitine level determination. Eighty-three percent of these patients (15/18) had carnitine deficiency. Preliminary data analysis of 13 patients showed that total carnitine increased from 30.0 +/- 6.9 to 41.0 +/- 12.1 (mean +/- SD) after 1 week of supplementation (P = 0.01), and free carnitine increased from 24.3 +/- 6.1 to 33.8 +/- 9.8 (P = 0.004). Outcome measures were fatigue (BFI score), depression (CES-D), sleep disruption (ESS), and performance status (Karnofsky). Median (min, max) BFI score at baseline was 73 (46, 82) versus 50 (3, 82) after 1-week supplementation (P = 0.009). CES-D score at baseline was 29 (16, 42) and 22 (8, 32) after 1 week (P = 0.028). ESS at baseline was 46.5 (0, 69) and 30.4 (0, 72) after 1 week (P = 0.015). Karnofsky score did not change significantly (P = 0.38). We are currently conducting a randomized, double-blind, placebo-controlled study to rigorously assess the role of L-carnitine for the treatment of fatigue and depression in cancer patients.

Carnitine↗
PubMed1999

Is quality of life predictive of the survival of patients with advanced nonsmall cell lung carcinoma?

BACKGROUND: Several studies have recently reported on the importance of quality of life (QOL) in predicting the survival of patients with lung carcinoma. To confirm these reports, the relationship between survival and QOL, as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire and Duke-UNC Social Support Scale, was examined within a group of 206 patients with advanced nonsmall cell lung carcinoma treated in a randomized clinical trial conducted by the Cancer and Leukemia Group B (CALGB 8931). METHODS: Patients completed the EORTC instrument and the Duke-UNC Social Support Scale at baseline in the clinic. The Cox proportional hazards model was used to determine the incremental contribution QOL provided in predicting survival beyond the effect of known clinical prognostic variables. RESULTS: Clinical factors that were jointly predictive of poorer survival included low performance status, nonadenocarcinoma histology, presence of dyspnea, weight loss greater than 5%, albumin level less than 3.5 mg/dL, and adrenal metastases. Univariate analyses showed that patient-reported EORTC subscales describing increased pain, appetite loss, fatigue, lung carcinoma symptoms, poorer overall QOL, and poorer physical functioning predicted significantly poorer survival. Multivariate analyses showed that, after adjustment for clinical factors, overall QOL was not a significant predictor of survival. Rather, the only EORTC subscale of prognostic importance was the pain subscale, in which a 40-point increase was associated with a 27% increase in the hazard rate. CONCLUSIONS: This study did not confirm the prognostic importance of overall QOL. Rather, after adjustment for significant clinical factors, a patient-provided pain report had the greatest prognostic importance.

Adult↗
PubMed1997

A longitudinal study of quality of life in advanced non-small cell lung cancer: Cancer and Leukemia Group B (CALGB) 8931.

A quality of life (QOL) endpoint supplemented standard clinical endpoints of survival, tumor response, and toxicity in a double-blind study conducted by the Cancer and Leukemia Group B (CALGB) where 291 patients with advanced non-small cell lung cancer (NSCLC) were randomly assigned to receive cisplatin/vinblastine with either hydrazine sulfate (HS) or placebo. The difficulties associated with the analysis of the longitudinal QOL data, and the contributions that the QOL endpoint made to the understanding of treatment differences, will be the focus of this paper.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1995

Free-riding and the prisoner's dilemma: problems in funding economic analyses of phase III cancer clinical trials.

PURPOSE: Both economic and clinical data on new agents are important to policy-makers who approve pharmaceuticals for widespread use. Randomized clinical trials have been used to evaluate both clinical results and total medical costs associated with new agents. With new expensive pharmaceutical agents, early assessments of economic benefit have taken on greater importance to physicians and patients. Who should provide financial support to these integrated economic and clinical analyses in clinical trials? Here we describe issues that hinder funding of economic analyses and propose potential support mechanisms. RESULTS: The Cancer and Leukemia Group B (CALGB), a large, national cooperative group of academic and community hospitals in the United States, designed a non-small-cell lung cancer (NSCLC) treatment trial to compare two widely used supportive care regimens that varied 20-fold in cost. One important objective of this trial was to compare the cost-effectiveness of the two regimens. While funding for the clinical trial was supported by grants from the National Cancer Institute and the pharmaceutical companies involved in the trial, no specific funding agency was willing and/or able to provide financial support for the economic analyses. After 2 years of planning, the clinical trial was retracted when the funding for the economic analyses could not be secured. The prisoner's dilemma, individual reluctance to support a common social good, explains the lack of funding. CONCLUSION: Economic theory predicts difficulties in evaluating cost-effectiveness of new pharmaceuticals and reluctance to support economic analyses of clinical trials. Economic analyses will require new sources of funds that will not take scarce resources from clinical trials groups. Options for funding include a new federal agency, coordinated work by existing agencies, or academic centers for economic analysis.

Carcinoma, Non-Small-Cell Lung↗
PubMedDate not supplied

A pilot study of interpersonal psychotherapy by telephone with cancer patients and their partners.

A single-arm pilot study explored the feasibility of adapting in Interpersonal Psychotherapy (IPT) by telephone to reduce psychological distress and to enhance coping during cancer treatment. Therapy focuses on role transitions, interpersonal conflicts, and grief precipitated by cancer. Breast cancer patients receiving high-dose chemotherapy received weekly sessions with a psychologist throughout chemotherapy and for 1 month afterwards. Patients could invite one 'partner' to receive individual telephone IPT. Psychosocial functioning was assessed using standardized measures at study entry, after chemotherapy, and following telephone IPT. Accrual and participation supplied evidence of feasibility: 14 patients and 10 partners were recruited, 82.5% of those eligible. Patients had a mean of 16 sessions; partners had a mean of 11. Participants rated their satisfaction with the program between 'good' and 'excellent'. A test of the efficacy of telephone IPT requires a larger, randomized trial. In order to standardize the intervention, a treatment manual was developed. This study indicated the importance of outreach to family members as well as to cancer patients, intensive patient education about oncology treatment and the medical care setting, and psychosocial services that continue after cancer treatment has been completed.

Adaptation, Psychological↗
PubMedDate not supplied

Involving family members in cancer care: focus group considerations of patients and oncological providers.

Family members are an integral part of a patient's cancer care from the moment the diagnosis is delivered to the conclusion of treatment. Family members bring with them a range of emotional reactions, interpersonal dynamics and expectations for the care the patient receives. This study is part of a multi-institutional project to continue to improve the process of cancer care. In this study, 19 focus groups (11 patient and 8 provider) were conducted concerning issues related to doctor-patient communication in eight cancer centers in the United States. The content of the conversations was analyzed and thematic categories emerged that highlight the various strengths and difficulties associated with family involvement. The focus groups' comments support the need for explicit conversations between professional caregivers, patients and their loved ones, in order to negotiate the expectations and needs of each team member. Implications for clinical practice and strategies for working with family members are offered.

Adaptation, Psychological↗