Biomedical subjects

D Cella

Publications and source records attributed to D Cella.

At least 55 records · Page 3Linked to original sources

PubMed1999

[Development of Japanese version of QOL questionnaire for bladder and prostate cancer patients using FACT-Bl and P: pilot study].

BACKGROUND: Quality of life (QOL) has been known to be a prognostic factor as well as the endpoint of treatment efficacy in many clinical fields. We have begun a US-Japan collaborative project introducing a QOL questionnaire, the FACT (Functional Assessment of Cancer Therapy), into Japan. We report on the translation process, results of the pilot study, and future plans for translating the Japanese version of the FACT subscales, FACT-Bl (for bladder cancer) and FACT-P (for prostate cancer). METHODS: The FACT translation procedure, which is quite rigorous, follows a four-step methodology. After completing the translations, we tested the translated FACT-G (general questionnaire) and subscales for bladder and prostate cancer patients. The questionnaires were tested on 30 outpatients at Tsukuba University Hospital (15 bladder, 15 prostate). The only eligibility requirement to participate in the study was a confirmed diagnosis of cancer of the bladder or prostate. RESULTS AND DISCUSSION: There was satisfactorily high internal consistency of FACT-G of both bladder and prostate cancer patients. FACT-Bl study included patients having undergone radical cystectomy as well as those who had not. Because not all items were answered by all patients, the Cronbach's alpha coefficient for the FACT-Bl subscale could not be computed. Further evaluation of the FACT-Bl concerning the surgical procedures affecting QOL is needed. We are currently planning to make the further refinement of the questionnaire in order to make it more suitable for bladder cancer patients. FACT-P subscale had an alpha coefficient of 0.82 and was determined to be useful in its present form.

Aged↗

PubMed1999

Quality of life and treatment value in the management of hematologic malignancies.

This report is an overview of quality-of-life (QOL) concerns among people living with hematologic malignancies, and attempts to place these concerns in the context of overall therapeutic benefit and treatment value. There are two general categories of potential benefit offered by any treatment: time and QOL. If time can be added by a treatment, either by cure or prolonging survival, the value of that time makes toxicity more tolerable to patients, providers, payers, and society. If QOL can be improved, this will also make toxicity more acceptable. However, in the absence of time extension, this trade-off must demonstrate that the QOL benefit clearly outweighs the toxicity. In other words, the acceptability of toxicity increases as the likelihood of benefit improves. The range of possible symptoms and functional problems associated with hematologic malignancies is diverse, characterized by site and degree of involvement. Uncertainty of prognosis and the need to tolerate ambiguity frame many of the emotional challenges that face patients who must make difficult treatment and follow-up decisions. As more QOL data become available from clinical trials in hematologic malignancies, treatment decisions, while still difficult, can be made with more information about risk, type of improvements, toxicities, and probability of overall clinical benefit.

Antibodies, Monoclonal↗

PubMed1998

The impact of a brief problem-solving training intervention for relatives of recently diagnosed breast cancer patients.

Previous studies have found high levels of psychological distress in women who have a family history of breast cancer. We evaluated a brief Problem-Solving Training (PST) intervention designed to reduce distress among women with a first-degree relative recently diagnosed with this disease. Participants were randomly assigned to either the PST group (N = 144) or a General Health Counseling (GHC) control group (N = 197). At baseline, these groups did not differ on any sociodemographic, risk factor, or psychological distress variables. We evaluated the impact of PST, relative to GHC, at the three-month follow-up assessment using a 2 (treatment group) x 2 (time of assessment) mixed factor analysis of variance (ANOVA). Although there were significant decreases in both cancer-specific and general distress in both the PST and GHC groups, the magnitude of these decreases did not differ. However, when PST participants were divided into those who regularly practiced the PST techniques and those who did not, significant differences emerged. Participants who regularly practiced the PST techniques had significantly greater decreases in cancer-specific distress [Impact of Event Scale (IEs) intrusion and avoidance subscales] compared to infrequent practicers and GHC participants. Effects on general distress were not found. Additional studies are needed to identify ways to promote the practice of PST techniques and to evaluate other psychosocial interventions for female relatives of breast cancer patients.

Adaptation, Psychological↗

PubMed1998

Spanish language translation and initial validation of the functional assessment of cancer therapy quality-of-life instrument.

OBJECTIVES: There is a need in the United States for culture-equivalent assessment of health-related quality of life, particularly among people who speak different languages and among those with low literacy skills. This report summarizes the adaptation of the Functional Assessment of Cancer Therapy (FACT) Scales for use with Spanish-speaking cancer patients, including those with low literacy. METHODS: The Spanish language version of the general Functional Assessment of Cancer Therapy scale plus five disease-specific subscales (breast, lung, colorectal, head and neck, HIV infection) were translated, reviewed, and revised, then evaluated in interviews with Spanish-speaking patients from the mainland United States and Puerto Rico. An iterative forward-backward-forward sequence of item translation, expert bilingual/bicultural advisor review, pretesting interviews with 92 patients, and further expert advisory input were used to establish semantic, content, and partial technical equivalence. RESULTS: The Functional Assessment of Cancer Therapy-General and five disease-specific subscales were translated successfully into wording that was easily understood and answered, leading to psychometric and scoring data similar to that of the English version. All but one of the 28 Functional Assessment of Cancer Therapy-General items and all of the disease-specific items were seen as culturally relevant. The result is a document that underwent iterative forward-backward translation and evaluation and was pretested successfully with native Spanish-speaking oncology patients living in the Central United States and Puerto Rico. CONCLUSIONS: The Functional Assessment of Cancer Therapy-General and five disease-specific subscales have been translated successfully into Spanish using a thorough translation and initial validation methodology. The methods and data provide a model for preparing a health status questionnaire for cross-cultural validation. The questionnaire is available for use in clinical trials and clinical practice.

Acculturation↗

PubMed1998

Genetic counseling and testing for breast-ovarian cancer susceptibility: what do women want?

PURPOSE: To assess preferences for the content and process of genetic counseling and testing for breast-ovarian cancer susceptibility among women at high risk for breast cancer. METHODS: Ninety-eight healthy women who had a family history of breast cancer in at least two first-degree relatives participated in a structured telephone survey that evaluated preferences for type of provider and the content and process of pretest education and posttest genetic counseling. RESULTS: Forty-two percent of women preferred that pretest education be delivered by a genetic counselor, while 22% preferred an oncologist. This preference was positively associated with a desire to discuss psychosocial issues during the session (P = .001). For posttest counseling, 38% of women preferred an oncologist, while 20% preferred a genetic counselor. However, women who desired supportive counseling during this session were significantly more likely to prefer a genetic counselor to an oncologist (P = .02). Fewer women wished to see a primary care physician or gynecologist for pretest education (11%) or posttest counseling (22%). With regard to the counseling process, 82% of women wished to self-refer for genetic counseling, but 63% desired advice and recommendations about whether to be tested. CONCLUSION: When feasible, the optimal approach may be for oncologists to work with genetic counselors to provide pretest education and medical recommendations. Elicitation of patients' preferences may be useful to determine the level of counseling services needed.

Adult↗

PubMed1998

Quality-of-life benefit in chemotherapy patients treated with epoetin alfa is independent of disease response or tumor type: results from a prospective community oncology study. Procrit Study Group.

PURPOSE: To evaluate prospectively the effectiveness of epoetin alfa as an adjunct to chemotherapy in patients with cancer based on changes in quality-of-life parameters and hemoglobin levels, and to correlate these changes with antitumor response. PATIENTS AND METHODS: Two thousand three hundred seventy patients with nonmyeloid malignancies who received chemotherapy were enrolled onto this study from 621 US community-based practices. Patients received epoetin alfa 10,000 U three times weekly, which could be increased to 20,000 U three times weekly depending on the hemoglobin response at 4 weeks. Treatment continued for a maximum of 16 weeks in patients who showed evidence of hematologic response. RESULTS: Two thousand two hundred eighty-nine patients (97%) were eligible for efficacy analyses. Epoetin alfa therapy was associated with improved quality-of-life parameters; these improvements correlated significantly with hemoglobin levels and were independent of tumor response. Provider-reported Karnofsky performance scores did not correlate with the improved quality-of-life changes. Epoetin alfa therapy was also associated with a significant increase in hemoglobin levels and decrease in transfusion use. Tumor type, chemotherapy agent/regimen, prior chemotherapy, baseline hemoglobin level, and baseline erythropoietin level were not predictive of a positive response to treatment. Epoetin alfa was well tolerated. CONCLUSION: Epoetin alfa appears to have a beneficial impact on patient-reported functional capacity and quality of life in patients with cancer who received chemotherapy independent of tumor response. Concordantly, epoetin alfa appeared to increase hemoglobin levels and decrease transfusion use. Patients responded across all tumor types. The results suggest that epoetin alfa effectively improves functional outcomes in patients with cancer who receive chemotherapy.

Aged↗

PubMed1998

Sixteen-week multidrug regimen versus cyclophosphamide, doxorubicin, and fluorouracil as adjuvant therapy for node-positive, receptor-negative breast cancer: an Intergroup study.

PURPOSE: The Intergroup conducted this breast cancer adjuvant trial to compare an investigational 16-week regimen with cyclophosphamide, doxorubicin, and fluorouracil (5-FU; CAF). The 16-week regimen features greater doxorubicin and 5-FU dose-intensity than CAF and improved scheduling of antimetabolites with sequential methotrexate and 5-FU, as well as infusion 5-FU. PATIENTS AND METHODS: A total of 646 node-positive, receptor-negative patients were randomly assigned to receive either the 1 6-week regimen or six cycles of CAF. Breast cancer outcomes included recurrence as well as disease-free and overall survival. Toxicity was evaluated by the Common Toxicity Criteria (CTC). Treatment-related quality of life was assessed by the Breast Chemotherapy Questionnaire (BCQ) before, during, and 4 months after treatment in 163 patients. The trial was designed to use one-sided tests of significance for power calculations, but is now reported with both one-sided and the traditional two-sided tests of significance. RESULTS: At a median follow-up of 3.9 years, the estimated 4-year recurrence-free survival rate was 67.5% with the 16-week regimen versus 62.7% with CAF (P = .19, two-sided; P = .095, one-sided). The estimated 4-year survival rate was 78.1% with the 16-week regimen versus 71.4% with CAF (P = .10, two-sided; P = .05, one-sided). CAF produced significantly higher grades of leukopenia, granulocytopenia, and thrombocytopenia, as well as liver and cardiac toxicity, whereas the 16-week regimen produced significantly higher grades of anemia, nausea, stomatitis, and weight loss, as well as skin and neurotoxicity. There were three treatment-related deaths with CAF but none with the 16-week regimen. During treatment, quality of life declined significantly more with the 16-week regimen than CAF, but by 4 months posttreatment, there was no difference. CONCLUSION: The 16-week regimen produced marginally better breast cancer outcomes than CAF with similar toxicity but a greater reduction in during-treatment quality of life. The 16-week regimen should not be used instead of a standard-dose regimen without careful consideration of the 16-week regimen's pros and cons, which include its complicated schedule. It should probably not be tested further, but its antimetabolite schedules and frequent drug administration (ie, dose density) should be considered in the development of new regimens.

Adult↗

PubMed1998

Progress toward guidelines for the management of fatigue.

Fatigue is a subjective state of overwhelming, sustained exhaustion and decreased capacity for physical and mental work that is not relieved by rest. Cancer-related fatigue has many causes. Included in the causes are the illness itself, the side effects of virtually every treatment, depression, and other biopsychosocial factors. As a result, fatigue is the most common symptom reported by cancer patients in most descriptive studies. In addition to arising from multiple etiologies, fatigue is also multidimensional in its manifestation and impact. Its effect on the quality of life of the patient is comparable to that of pain. Experienced by most patients as an extremely frustrating state of chronic energy depletion, it leads to loss of productivity which can reduce self-esteem. As a subtle and chronic symptom, it also places people at risk for being questioned about the veracity of their complaints, particularly during the post-treatment, disease-free survival period. Patients themselves are reluctant to complain of fatigue, perhaps because they believe little can be done about it, or they wish to avoid drawing attention away from treating their cancer.

Fatigue↗

PubMed1998

Quality of life in patients with low-grade non-Hodgkin's lymphoma.

Low-grade non-Hodgkin's lymphoma (NHL) is an indolent form of the disease with a generally slow course of progression. Although still usually incurable, low-grade disease has shown responsiveness to some of the newer chemotherapeutic and nonchemotherapeutic treatment options. However, since cure remains elusive, and since many patients with lowgrade NHL may have few or even no symptoms initially, the decision about whether or not to initiate treatment logically must include quality-of-life (QOL) issues. This paper summarizes clinical and diagnostic characteristics of low-grade NHL that have some bearing on QOL considerations. Adverse effects of the more common treatment approaches are discussed according to their QOL implications, illustrating the relevance of QOL to the clinical management of low-grade disease. Finally, data from an ongoing study using the Functional Assessment of Cancer Therapy (FACT) measurement system are presented. These data offer a basis for comparing the QOL of patients with NHL to that of individuals with other solid tumors, and also illustrate the effects of chemotherapy on QOL.

Humans↗

PubMed1998

[Health-related quality of life: important result of cancer treatments].

Health related quality of life is an integral part of the outcomes of cancer treatment. The purpose of this manuscript is to describe the concept of quality of life of cancer patients, and to summarize the validation studies of the "Functional Assessment Cancer Therapy Scales" (FACT) in Hispanics. Results of the studies support the validity of the scale which has the following dimensions: physical well-being, social/family well-being, relationship with doctor, emotional well-being, and functional well-being. The validation work makes possible the assessment of quality of life in Hispanics. Clinical trials which assess health related quality of life as a treatment outcome provide baseline information for decision making in the financing of oncology treatments.

Clinical Trials as Topic↗

PubMed1998

Factors influencing quality of life in cancer patients: anemia and fatigue.

Anemia is a multi-symptom syndrome involving both physical and emotional problems that can be evaluated for their impact on quality of life. Fatigue is the cardinal symptom of anemia, reported by three of four cancer patients using the general version of the Functional Assessment of Cancer Therapy (FACT-G) questionnaire. A subscale of the FACT-G, consisting of the FACT-Fatigue (FACT-F) and the FACT-Anemia (FACT-An), has been developed to specifically address this problem. The FACT-F is comprised of the FACT-G plus 13 questions related to fatigue, while the FACT-An is comprised of the FACT-F plus an additional set of seven miscellaneous (non-fatigue) questions relevant to anemia in cancer patients. The FACT-An subscale was initially validated in a cohort of 50 cancer patients. Tests of internal consistency and stability confirmed the reliability of the fatigue component, as well as that of the FACT-G (27 items), the FACT-F (FACT-G plus 13 fatigue items), and the FACT-An (FACT-G plus 20 anemia subscale items) measurement systems. Quality of life scores on these FACT scales significantly decline as patient performance status worsens, and the scales correlate well with other questionnaires (Profile of Mood States and Piper Fatigue Scale) purported to measure the same thing. The scores on the FACT-An subscale also clearly differentiate between patients with low and high hemoglobin levels. Low hemoglobin levels are associated with greater fatigue, poorer overall quality of life, and decreased ability to work (beyond that related directly to fatigue). Interventions that reverse fatigue and other anemia-related symptoms should have a positive effect on quality of life.

Anemia↗

PubMed1997

Influence of breast- and formula-feeding on plasma cholesterol precursor sterols throughout the first year of life.

We evaluated endogenous cholesterol synthesis and plasma lipid profile longitudinally from birth to 1 year old in infants who were exclusively breast-fed (n = 19) or formula-fed (n = 19) for the first 4 months of life. At 1 and 4 months of age, breast-fed infants had higher plasma total and low-density lipoprotein cholesterol and apolipoprotein B levels than formula-fed infants, whereas plasma mevalonate and lanosterol levels were not different between the two study groups.

Analysis of Variance↗

PubMed1997

Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument.

OBJECTIVES: As the incidence of prostate cancer in the United States exceeds 330,000 in 1997, increasingly more men are faced with treatment choices for which there is no clear approach. At every stage of disease, these treatment choices may involve clinically equivalent modalities that differ in side effects and impact upon quality of life (QOL). Comprehensive, yet efficient, questionnaires are needed to measure QOL in patients with prostate cancer. METHODS: Developed as a disease-specific adjunct to the Functional Assessment of Cancer Therapy (FACT) measurement system, a 12-item prostate cancer subscale (PCS) was developed and tested in three independent samples: a subscale development sample (n = 43), validity sample 1 (n = 34), and validity sample 2 (n = 96). The 12 items ask about symptoms and problems specific to prostate cancer. These questions are added to the general (FACT-G) instrument, thereby comprising a 47-item questionnaire. RESULTS: Internal consistency of the PCS ranged from 0.65 to 0.69, with coefficients for FACT-G subscales and aggregated scores ranging from 0.61 to 0.90. Concurrent validity was confirmed by the ability to discriminate patients by disease stage, performance status, and baseline prostate-specific antigen (PSA) level. Sensitivity to change in performance status and PSA score over a 2-month period suggested that some subscales of the FACT-Prostate (P) (including the PCS) are sensitive to meaningful clinical change. CONCLUSIONS: Our findings support use of the FACT-P as a meaningful component of QOL evaluation in men undergoing therapy for prostate cancer.

Aged↗

PubMed1997

Psychometric validation of the revised Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life instrument.

The revised Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life (QoL) instrument has been updated and expanded to provide more complete and accurate coverage of human immune deficiency virus/acquired immune deficiency syndrome (HIV/AIDS)-related QoL. Factor analysis and the Rasch measurement model were used to determine a new subscale structure for the FAHI. The content of these subscales, including physical well-being (ten items, alpha = 0.91), function and global well-being (13 items, alpha = 0.86), emotional well-being/living with HIV (10 items, alpha = 0.82), social well-being (eight items, alpha = 0.73), and cognitive functioning (three items; alpha = 0.75), reflect both general illness- and HIV/AIDS-specific QoL concerns: a total QoL score can also be calculated for the FAHI (44 items, alpha = 0.91). Psychometric evaluation revealed good internal consistency reliability for the FAHI and its subscales. In addition, construct validity, known groups validity and sensitivity to change were demonstrated by significant associations between the FAHI and additional indicators of functional status, psychological symptoms, stress and illness severity. In summary, the FAHI is a psychometrically sound instrument that captures multiple important dimensions of HIV/AIDS-related QoL. It is brief, easy to administer and score, has been translated into nine languages other than English and is appropriate for use in clinical trials and clinical practice.

Activities of Daily Living↗

PubMed1997

Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. The Fatigue Coalition.

Although fatigue is the most common symptom reported by cancer patients and has serious adverse effects on quality of life, it remains poorly understood. A survey was designed to characterize the epidemiology of cancer-related fatigue from the perspectives of the patient, primary caregiver, and oncologist. A telephone survey included 419 cancer patients recruited from 100,000 randomly selected households nationwide. Patients provided access to 200 primary caregivers (usually family members) who were also interviewed by telephone. In a separate mail survey, 197 of 600 randomly sampled oncologists (unrelated to the patients) responded to a questionnaire that assessed perceptions and attitudes concerning fatigue in cancer patients who had received chemotherapy or radiotherapy and their caregivers. The median patient age was 65 years, and the principal cancer diagnoses were breast (females) and genitourinary (males). Fifty-nine percent of the patients had received chemotherapy, 63% radiation therapy, and 24% both; 20% of patients received their last treatment within 6 weeks, 31% within 7 weeks to 1 year, and 49% more than 1 year ago. More than three quarters of patients (78%) experienced fatigue (defined as a general feeling of debilitating tiredness or loss of energy) during the course of their disease and treatment. Thirty-two percent experienced fatigue daily, and 32% reported fatigue significantly affected their daily routines. Caregivers reported observing fatigue in 86% of the index patients, and oncologists perceived that 76% of their patients experienced fatigue. Although oncologists believed that pain adversely affected their patients to a greater degree than fatigue (61% v 37%), patients felt that fatigue adversely affected their daily lives more than pain (61% v 19%). Most oncologists (80%) believed fatigue is overlooked or undertreated, and most patients (74%) considered fatigue a symptom to be endured. Fifty percent of patients did not discuss treatment options with their oncologists, and only 27% reported that their oncologists recommended any treatment for fatigue. When used, treatments for fatigue were generally perceived by patients and caregivers to be successful. These data confirm the high prevalence and adverse impact of cancer-related fatigue, although it is seldom discussed and infrequently treated. For patients and oncologists, improving the quality of life of cancer patients requires a heightened awareness of fatigue, a better understanding of its impact, and improve communication and familiarity with interventions that can reduce its debilitating effects.

Aged↗

PubMed1997

The Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scale: a new tool for the assessment of outcomes in cancer anemia and fatigue.

Anemia, frequently associated with cancer and cancer treatment, can use a variety of symptoms that diminish overall quality of life (QOL). Fatigue is the most commonly reported symptom among cancer patients and can significantly affect their daily lives. Using the Functional Assessment of Cancer Therapy-General (FACT-G) instrument, which measures general QOL, as a core questionnaire, 20 new questions related to the impact of fatigue and other anemia-related symptoms on patients with cancer were developed. Two new instruments were produced: the FACT-Fatigue (FACT-F), consisting of the FACT-G plus 13 fatigue items (the Fatigue Subscale), and the FACT-Anemia (FACT-An), consisting of the FACT-F plus seven items addressing other concerns related to anemia, but unrelated to fatigue. FACT-F and FACT-An demonstrated good stability (r = .87 for both) and strong internal consistency (alpha = .95 and .96, respectively). Test-retest reliability coefficients for the Fatigue Subscale and nonfatigue items also showed good stability (r = .84 to .90), and the Fatigue Subscale showed strong internal consistency (alpha = .93 to .95). Convergent and discriminant validity testing revealed a significantly positive relationship with other known measures of fatigue, a significant negative relationship with vigor, and an anticipated lack of relationship with social desirability. The FACT-An, FACT-F, and Fatigue Subscale were found to successfully discriminate patients based on hemoglobin (Hb) level and Eastern Cooperative Oncology Group (ECOG) performance status. When patients were divided into two groups by Hb levels, patients with Hb levels greater than 12 g/dL reported significantly less fatigue, fewer nonfatigue anemia symptoms, better physical well-being, better functional well-being, and higher general QOL. The FACT-An, the FACT-F, and the Fatigue Subscale are useful measures of QOL in cancer patients and add focus to the widespread clinical problems of anemia and fatigue.

Adult↗

PubMed1997

Linking outcomes management to quality-of-life measurement.

Health-care workers now accept quality of life (QOL) as an important outcome to evaluate in clinical research and as a useful measure of quality care. Indeed, current demand for QOL assessment in clinical practice has outpaced the availability of valid, streamlined, cost-effective methods for carrying out such assessment, although new tools are in the offing. This paper will highlight some of the major challenges facing outcomes management and outcomes research, with particular focus on the development of a QOL instrument to evaluate and manage anemia and fatigue in cancer patients--the Functional Assessment of Cancer Therapy-Anemia (FACT-An). The newest version of broader QOL assessment system, the Functional Assessment of Chronic Illness Therapy (FACIT), will also be described.

Cohort Studies↗

PubMed1996

Establishing equivalence between scaled measures of quality of life.

In this paper, methodologies which have been used in the pharmaceutical industry to demonstrate the equivalence of drug preparations, are applied to the measurement of quality of life (QOL). This approach is feasible when the generated data are measured on the same scale. Data from the quality of life instruments are transformed into interval scales by means of an appropriate scaling procedure. It is demonstrated that equivalence of QOL instruments is linked by a linear relationship between the QOL instruments Functional Assessment of Cancer Therapy (FACT) and the Functional Living Index-Cancer (FLIC). The linear relationship is derived using orthogonal least squares regression which takes into account that both measures are subject to error.

Activities of Daily Living↗