RESUMEN
BACKGROUND: Partially presented in poster format at the 40th and 41st Annual Meetings of the American Society of Clinical Oncology, held in 2004 in New Orleans, Louisiana and in 2005 in Orlando, Florida. PURPOSE: We aimed to: (a) assess patient knowledge about cancer clinical trials (CCT) and satisfaction with their decision to participate, (b) determine whether satisfaction correlates with objective understanding, or other factors, and (c) identify correlates of increased understanding. METHODS: A convenience sample of 100 patients were recruited. Instruments assessed quality of informed consent (QuIC), quality of life (EORTC QLQ C-30), anxiety and depression (HADS), and preferences for information and involvement in decision making. Measures were completed within 2 weeks of clinical trial enrollment. RESULTS: One hundred two patients (68 male) with a median age of 58.4 years (29-85) were registered in 27 of the 33 therapeutic cancer clinical trials approved for the Consent Study. Mean QuIC objective knowledge (QuIC-A) was 77.6 (/100) (95% CI, 75.7-79.4) and perceived (subjective) understanding (QuIC-B) 91.5 (95% CI, 89.6-93.3). There was low but significant correlation between QuIC-A and B (R = 0.26, p = 0.008). Satisfaction was very high. Correlation between QuIC-B and satisfaction was moderate (0.430, p < 0.001). QuIC-B, but not QuIC-A was associated with QOL scores. Preferences regarding participation in decision making and whether these preferences were achieved did not impact upon knowledge, understanding or satisfaction. CONCLUSIONS: Patient knowledge regarding CCT is similar to published US data, and satisfaction is high. Satisfaction correlates with perceived but not objective understanding of CCT. Strategies to further improve the consent process need to be developed.
Asunto(s)
Ensayos Clínicos como Asunto/métodos , Conocimientos, Actitudes y Práctica en Salud , Satisfacción del Paciente , Sujetos de Investigación/psicología , Adulto , Anciano , Anciano de 80 o más Años , Toma de Decisiones , Femenino , Humanos , Consentimiento Informado/psicología , Masculino , Persona de Mediana Edad , Neoplasias/terapia , Participación del Paciente/psicología , Selección de Paciente , Calidad de VidaRESUMEN
BACKGROUND: Prophylactic low dose i.v. ganciclovir in patients at risk after allogeneic bone marrow transplantation (BMT) is highly effective in the prevention of cytomegalovirus (CMV) disease and infection. AIM: In this study, we sought to assess the tolerability of oral ganciclovir in patients after allogeneic BMT. METHODS: CMV seropositive patients or those with CMV seropositive donors were randomised to be treated with i.v. ganciclovir 5 mg/kg three times weekly or oral ganciclovir 3 g daily from engraftment to day 84. The period of accrual was from May 1997 to October 1998. Patients were monitored for CMV infection by weekly serology. Thirty-one patients received oral ganciclovir and 27 patients received i.v. ganciclovir, the treatment groups being balanced for clinical characteristics and prognostic factors. RESULTS: Renal dysfunction, transfusion requirements and significant nausea and vomiting were not different. There were no documented cases of CMV disease during the study period although three patients developed CMV polymerase chain reaction positivity at various times. One patient treated with i.v. ganciclovir developed non-fatal gastrointestinal CMV disease after the study period on day 108. Eight patients in the oral group failed to complete planned therapy, whereas two patients failed to complete the i.v. course. CONCLUSION: We conclude that oral ganciclovir is a reasonable, well-tolerated alternative to i.v. ganciclovir for the prophylaxis of CMV disease after allogeneic BMT.
Asunto(s)
Antivirales/uso terapéutico , Trasplante de Médula Ósea , Infecciones por Citomegalovirus/prevención & control , Ganciclovir/administración & dosificación , Complicaciones Posoperatorias/prevención & control , Administración Oral , Adolescente , Adulto , Infecciones por Citomegalovirus/tratamiento farmacológico , Humanos , Infusiones Intravenosas , Persona de Mediana Edad , Complicaciones Posoperatorias/tratamiento farmacológicoRESUMEN
To define an optimal regimen for mobilizing and collecting peripheral blood progenitor cells (PBPC) for use in allogeneic transplantation, we evaluated the kinetics of mobilization by filgrastim (recombinant met-human granulocyte colony-stimulating factor [r-metHuG-CSF]) in normal volunteers. Filgrastim was injected subcutaneously for up to 10 days at a dose of 3 (n = 10), 5 (n = 5), or 10 micrograms/kg/d (n = 15). A subset of volunteers from each dose cohort underwent a 7L leukapheresis on study day 6 (after 5 days of filgrastim). Granulocyte-macrophage colony-forming cell (GM-CFC) numbers in the blood were maximal after 5 days of filgrastim; a broader peak was evident for CD34+ cells between days 4 and 6. The 95% confidence intervals (CI) for mean number of PBPC per milliliter of blood in the three dose cohorts overlapped on each study day. However, on the peak day, CD34+ cells were significantly higher in the 10 micrograms/kg/d cohort than in a pool of the 3 and 5 micrograms/kg/d cohorts. Mobilization was not significantly influenced by volunteer age or sex. Leukapheresis products obtained at the 10 micrograms/kg/d dose level contained a median GM-CFC number of 93 x 10(4)/kg (range, 50 x 10(4)/kg to 172 x 10(4)/kg). Collections from volunteers receiving lower doses of filgrastim contained a median GM-CFC number of 36 x 10(4)/kg (range, 5 x 10(4)/kg to 204 x 10(4)/kg). The measurement of CD34+ cells per milliliter of blood on the day of leukapheresis predicted the total yield of PBPC in the leukapheresis product (r = .87, P < .0001). Assuming a minimum GM-CFC requirement of 50 x 10(4)/kg (based on our experience with autologous PBPC transplantation), all seven leukapheresis products obtained at the 10 micrograms/kg/d dose level were potentially sufficient for allogeneic transplantation purposes. We conclude that in normal donors, filgrastim 10 micrograms/kg/d for 5 days with a single leukapheresis on the following day is a highly effective regimen for PBPC mobilization and collection. Further studies are required to determine whether PBPC collected with this regimen reliably produce rapid and sustained engraftment in allogeneic recipients.