RESUMEN
BACKGROUND: Maintenance of function during cancer treatment is important to older adults. Characteristics associated with pretreatment life-space mobility and changes during non-small cell lung cancer (NSCLC) treatment remain unknown. METHODS: This mixed methods cohort study recruited adults age ≥65 with advanced NSCLC starting palliative chemotherapy, immunotherapy, and/or targeted therapy from a Comprehensive Cancer Center, Veterans Affairs, and safety-net clinic. Patients completed geriatric assessments including Life-Space Assessment (LSA) pretreatment and at 1, 2, 4, and 6 months after treatment initiation. LSA scores range from 0 to 120 (greater mobility); LSA <60 is considered restricted. We used mixed-effects models to examine pretreatment LSA, change from 0 to 1 month, and change from 1 to 6 months. A subgroup participated in semistructured interviews pretreatment and at 2 and 6 months to understand the patient experience of life-space change. For each interview participant, we created joint displays of longitudinal LSA scores juxtaposed with illustrative quotes. RESULTS: Among 93 patients, median age was 73 (range 65-94). Mean pretreatment LSA score was 67.1. On average, LSA declined 10.1 points from pretreatment to 1 month and remained stable at 6 months. Pretreatment LSA score was associated with several demographic, clinical, geriatric assessment, and symptom characteristics. LSA decline at 1 month was greater among patients with high anxiety (slope = -12.6 vs. -2.3, p = 0.048). Pretreatment body mass index <21 kg/m2 was associated with LSA improvement from 1 to 6 months (slope = 4.1 vs. -0.04, p = 0.003). Joint displays illustrated the impact of different life-space trajectories on patients' lives in their words. CONCLUSION: Older adults with NSCLC have low pretreatment life space with many developing restricted life space during treatment. Incorporating life-space assessments into clinical cancer care may help older adults concretely visualize how treatment might impact their daily function to allow for informed decision making and identify early changes in mobility to implement supportive interventions.
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Actividades Cotidianas , Carcinoma de Pulmón de Células no Pequeñas/terapia , Evaluación Geriátrica , Neoplasias Pulmonares/terapia , Anciano , Anciano de 80 o más Años , Carcinoma de Pulmón de Células no Pequeñas/psicología , Femenino , Humanos , Neoplasias Pulmonares/psicología , Masculino , Limitación de la Movilidad , Estudios ProspectivosRESUMEN
PURPOSE: CALGB 49907 showed the superiority of standard therapy, which included either cyclophosphamide/doxorubicin (AC) or cyclophosphamide/methotrexate/fluorouracil over single-agent capecitabine in the treatment of patients age ≥ 65 with early-stage breast cancer. The treatment allowed dosing adjustments of methotrexate and capecitabine for pretreatment renal function. The purpose of the current analysis was to assess the relationship between pretreatment renal function and five end points: toxicity, dose modification, therapy completion, relapse-free survival, and overall survival. METHODS: Pretreatment renal function was defined as creatinine clearance (CrCl) using the Cockcroft-Gault equation. Multivariable logistic and proportional hazards regression were used to model separately for each regimen the relationship between CrCl and the first three binary end points and the last two time-to-event end points, respectively, after adjusting for variables of prognostic importance. RESULTS: Six hundred nineteen assessable patients were analyzed. The incidence of stage III (moderate) or stage IV (severe) renal dysfunction was 72%, 64%, and 75% for treatment with cyclophosphamide/methotrexate/fluorouracil, AC, and capecitabine, respectively. There was no relationship for any regimen between pretreatment renal function and the five end points. For AC, as CrCl increased, the odds of nonhematologic toxicity decreased (P = .008), whereas for capecitabine, as CrCl increased, the odds of experiencing toxicity of any type also increased (P = .035). Patients with renal insufficiency who received dose modifications were not at increased risk for complications compared with those who did not have renal insufficiency and received a full dose. CONCLUSION: Excluding from clinical trials patients with renal insufficiency but good performance status on the basis of concern of excessive hematologic toxicity or poor outcomes may not be justified with appropriate dosing modifications. Results should be considered in the design of clinical trials for older patients.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Insuficiencia Renal/fisiopatología , Anciano , Inhibidores de la Aromatasa/administración & dosificación , Capecitabina/administración & dosificación , Creatinina/orina , Ciclofosfamida/administración & dosificación , Femenino , Fluorouracilo/administración & dosificación , Humanos , Pruebas de Función Renal , Metotrexato/administración & dosificación , Pronóstico , Insuficiencia Renal/inducido químicamente , Tasa de Supervivencia , Tamoxifeno/administración & dosificación , Resultado del TratamientoRESUMEN
We examine the efficacy of conventional cognitive behavioral therapy (CCBT) versus religiously integrated CBT (RCBT) in persons with major depression and chronic medical illness. Participants were randomized to either CCBT (n = 67) or RCBT (n = 65). The intervention in both groups consisted of ten 50-minute sessions delivered remotely during 12 weeks (94% by telephone). Adherence to treatment was similar, except in more religious participants in whom adherence to RCBT was slightly greater (85.7% vs. 65.9%, p = 0.10). The intention-to-treat analysis at 12 weeks indicated no significant difference in outcome between the two groups (B = 0.33; SE, 1.80; p = 0.86). Response rates and remission rates were also similar. Overall religiosity interacted with treatment group (B = -0.10; SE, 0.05; p = 0.048), suggesting that RCBT was slightly more efficacious in the more religious participants. These preliminary findings suggest that CCBT and RCBT are equivalent treatments of major depression in persons with chronic medical illness. Efficacy, as well as adherence, may be affected by client religiosity.
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Terapia Cognitivo-Conductual/métodos , Trastorno Depresivo Mayor/terapia , Curación por la Fe/métodos , Religión y Psicología , Adulto , Enfermedad Crónica/epidemiología , Comorbilidad , Trastorno Depresivo Mayor/epidemiología , Trastorno Depresivo Mayor/psicología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Cooperación del Paciente/psicología , Proyectos Piloto , Teléfono , Resultado del TratamientoRESUMEN
OBJECTIVE: Religious involvement may help individuals with chronic medical illness cope better with physical disability and other life changes. We examine the relationships between religiosity, depressive symptoms, and positive emotions in persons with major depression and chronic illness. METHODS: 129 persons who were at least somewhat religious/spiritual were recruited into a clinical trial to evaluate the effectiveness of religious vs. secular cognitive behavioral therapy. Reported here are the relationships at baseline between religious involvement and depressive symptoms, purpose in life, optimism, generosity, and gratefulness using standard measures. RESULTS: Although religiosity was unrelated to depressive symptoms (F=0.96, p=0.43) and did not buffer the disability-depression relationship (B=-1.56, SE 2.90, p=0.59), strong relationships were found between religious indicators and greater purpose, optimism, generosity, and gratefulness (F=7.08, p<0.0001). CONCLUSIONS: Although unrelated to depressive symptoms in the setting of major depression and chronic medical illness, higher religious involvement is associated with positive emotions, a finding which may influence the course of depression over time.
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Adaptación Psicológica , Afecto , Actitud , Terapia Cognitivo-Conductual , Trastornos Mentales/psicología , Trastornos Mentales/terapia , Religión , Espiritualidad , Adulto , Anciano , Anciano de 80 o más Años , Enfermedad Crónica , Depresión/psicología , Depresión/terapia , Trastorno Depresivo/psicología , Trastorno Depresivo/terapia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Autoinforme , Apoyo Social , Encuestas y CuestionariosRESUMEN
OBJECTIVE: China is experiencing a rapid increase in cancer incidence in elderly patients. In order to better understand this group, a large study of patients from multiple tertiary centers in the Beijing area was designed. This study was designed to provide insight into their unique treatment preferences, including the use of traditional Chinese medicine (TCM). MATERIALS AND METHODS: 803 patients from nine hospitals in the Beijing area were enrolled into this study. The inclusion criteria were patients who were 65 years or older and had a diagnosis of cancer at any stage. The CGA questionnaire used with these patients included the Chinese translation of the Gero-Oncology Health and Quality of Life Assessment tool. The questionnaire was provided to patients by a research nurse and was administered in Mandarin. RESULTS: The mean age of the patients was 72 years (range 65-94). The patients were mainly male (59.8%) and of Han ethnicity (95.4%). About 45% of these patients also had concurrent TCM in addition to their other cancer treatments. About 70% were able to manage their activities of daily living without assistance. Patients on TCM were more likely to have higher number of co-morbidities compared to their counterparts. CONCLUSION: This is the largest prospective study of CGA assessments done on elderly patients with cancer in Asia. The study demonstrates that CGA provides insights into understanding the needs of elderly Chinese patients with cancer. TCM is used frequently in China, and its impact on quality of life needs further investigation.
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Actividades Cotidianas , Envejecimiento , Evaluación Geriátrica , Geriatría , Neoplasias/terapia , Calidad de Vida , Anciano , Anciano de 80 o más Años , China , Comorbilidad , Femenino , Necesidades y Demandas de Servicios de Salud , Humanos , Masculino , Oncología Médica , Neoplasias/diagnóstico , Estudios Prospectivos , Factores de Riesgo , Encuestas y CuestionariosRESUMEN
Cognitive changes in older women receiving chemotherapy are poorly understood. We examined self-reported cognitive function for older women who received adjuvant chemotherapy on Cancer and Leukemia Group B (CALGB) 49907. CALGB 49907 randomized 633 women aged ≥65 with stage I-III breast cancer to standard adjuvant chemotherapy (cyclophosphamide-methotrexate-5-fluorouracil or doxorubicin-cyclophosphamide) versus capecitabine. We examined self-reported cognitive function in 297 women (CALGB 361002) who enrolled on the quality of life substudy and had no gross impairment on cognitive screening. Women were evaluated using an 18-item instrument at six time points (baseline through 24 months). At each time point for each patient, we calculated a cognitive function score (CFS) defined as the mean response of items 1-18 and defined impairment as a score >1.5 standard deviations above the overall average baseline score. Differences in scores by patient characteristics were evaluated using a Kruskal-Wallis test. A linear mixed-effects model was used to assess CFSs by treatment over time. Among 297 women, the median age was 71.5 (range 65-85) and 73 % had performance status of 0. Baseline depression and fatigue were reported in 6 and 14 % of patients, respectively. The average CFS at baseline was 2.08 (corresponding to "normal ability"), and baseline cognitive function did not differ by treatment regimen (p = 0.350). Over 24 months, women reported minimal changes at each time point and insignificant differences by treatment arm were observed. In a healthy group of older women, chemotherapy was not associated with longitudinal changes in self-reported cognitive function.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/psicología , Cognición , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/diagnóstico , Capecitabina , Desoxicitidina/administración & dosificación , Desoxicitidina/análogos & derivados , Femenino , Fluorouracilo/administración & dosificación , Fluorouracilo/análogos & derivados , Humanos , Pruebas Neuropsicológicas , Calidad de Vida , Factores de Riesgo , Encuestas y CuestionariosRESUMEN
PURPOSE: A phase III trial (Cancer and Leukemia Group B CALGB-49907) was conducted to test whether older patients with early-stage breast cancer would have equivalent relapse-free and overall survival with capecitabine compared with standard chemotherapy. The quality of life (QoL) substudy tested whether capecitabine treatment would be associated with a better QoL than standard chemotherapy. PATIENTS AND METHODS: QoL was assessed in 350 patients randomly assigned to either standard chemotherapy (cyclophosphamide, methotrexate, and fluorouracil [CMF] or doxorubicin and cyclophosphamide [AC]; n = 182) or capecitabine (n = 168). Patients were interviewed by telephone before treatment (baseline), midtreatment, within 1 month post-treatment, and at 12, 18, and 24 months postbaseline by using questionnaires from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), a breast systemic adverse effects scale (EORTC BR23), and the Hospital Anxiety and Depression Scale (HADS). RESULTS: Compared with patients who were treated with standard chemotherapy, patients who were treated with capecitabine had significantly better QoL, role function, and social function, fewer systemic adverse effects, less psychological distress, and less fatigue during and at the completion of treatment (P ≤ .005). Capecitabine treatment was associated with less nausea, vomiting, and constipation and with better appetite than standard treatment (P ≤ .004), but worse hand-foot syndrome and diarrhea (P < .005). These differences all resolved by 12 months. CONCLUSION: Standard chemotherapy was superior to capecitabine in improving relapse-free and overall survival for older women with early-stage breast cancer. Although capecitabine was associated with better QoL during treatment, QoL was similar for both groups at 1 year. The brief period of poorer QoL with standard treatment is a modest price to pay for a chance at improved survival.
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Antimetabolitos Antineoplásicos/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Neoplasias de la Mama/tratamiento farmacológico , Desoxicitidina/análogos & derivados , Fluorouracilo/análogos & derivados , Calidad de Vida , Factores de Edad , Anciano , Antimetabolitos Antineoplásicos/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/patología , Neoplasias de la Mama/psicología , Neoplasias de la Mama/cirugía , Capecitabina , Quimioterapia Adyuvante , Ciclofosfamida/administración & dosificación , Ciclofosfamida/efectos adversos , Desoxicitidina/administración & dosificación , Desoxicitidina/efectos adversos , Supervivencia sin Enfermedad , Doxorrubicina/administración & dosificación , Doxorrubicina/efectos adversos , Femenino , Fluorouracilo/administración & dosificación , Fluorouracilo/efectos adversos , Humanos , Metotrexato/administración & dosificación , Metotrexato/efectos adversos , Estadificación de Neoplasias , Medición de Riesgo , Factores de Riesgo , Encuestas y Cuestionarios , Análisis de Supervivencia , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
Patients and family members often turn to prayer in response to serious, life-threatening illness. Prayer for a miraculous cure is often the request. While prayer can keep hope alive, it may also promote unrealistic expectations that fuel demands for life-preserving technology in medically futile situations. Furthermore, if prayer does not achieve the desired results, then disappointment and disillusionment may follow and make the coping process even more difficult. We present here a case of a seriously ill man whose family and faith community prayed for his healing. John, however, was not healed. A medical internist, two psychiatrists, a sociologist, and a theologian discuss their perspectives on the apparent failure of prayer to heal John. This cross-disciplinary discussion reveals insights that we believe physicians can use when confronting such issues with patients.
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Actitud del Personal de Salud , Cristianismo , Curación por la Fe/psicología , Neoplasias Pancreáticas/psicología , Religión y Psicología , Anciano , Conducta Cooperativa , Pesar , Humanos , Comunicación Interdisciplinaria , Masculino , Prueba de Realidad , Espiritualidad , Insuficiencia del TratamientoRESUMEN
Data Safety Monitoring Committees (DSMB) for large, long-term randomized trials of agents in common use face challenging problems especially when the emerging data indicate unanticipated effects. The DSMB for the Women's Health Initiative Clinical Trials, on observing early indication of a surprising adverse cardiovascular effect of post-menopausal hormones, spent several years deliberating what recommendations it should make. This paper describes the dilemmas faced by the DSMB and the considerations it made over the course of its existence. The paper concludes with some recommendations for other DSMBs.