ABSTRACT
OBJECTIVE: To highlight health related quality of life (HRQOL) measures and published outcomes in phase III clinical trials in the four major cancers: breast, prostate, colorectal, and lung. DATA SOURCES: Peer-reviewed journals, textbooks, and abstracts published between 1990 and 2009. CONCLUSION: Over the past 20 years there has been an upsurge in the number and types of HRQOL measures used in phase III cancer treatment trials. Results of trials reported after 2001 indicate a significant increase in specific treatment or disease-related symptom measures in lieu of or as companions to global HRQOL measures. Currently, open NCI-supported trials are incorporating a large number of targeted treatment- and/or disease-related measures. IMPLICATIONS FOR NURSING PRACTICE: Clinicians can use these data to help patients better understand the spectrum and severity of symptomatic toxicities they will experience with cancer treatment.
Subject(s)
Clinical Trials, Phase III as Topic , Neoplasms , Nursing Research/trends , Oncology Nursing/trends , Outcome Assessment, Health Care/trends , Quality of Life/psychology , Breast Neoplasms/psychology , Clinical Trials, Phase III as Topic/nursing , Clinical Trials, Phase III as Topic/psychology , Colorectal Neoplasms/psychology , Data Collection , Female , Humans , Lung Neoplasms/psychology , Male , National Cancer Institute (U.S.) , Neoplasms/nursing , Neoplasms/psychology , Nursing Assessment , Nursing Research/methods , Oncology Nursing/methods , Outcome Assessment, Health Care/methods , Prostatic Neoplasms/psychology , United StatesSubject(s)
Antibodies, Monoclonal/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Lymphoma, Follicular/nursing , Lymphoma, Non-Hodgkin/nursing , Antibodies, Monoclonal, Murine-Derived , Clinical Trials as Topic , Clinical Trials, Phase III as Topic/nursing , Disease Progression , Disease-Free Survival , Humans , Lymphoma, Follicular/drug therapy , Lymphoma, Follicular/mortality , Lymphoma, Non-Hodgkin/drug therapy , Lymphoma, Non-Hodgkin/mortality , Rituximab , Treatment OutcomeSubject(s)
Angiogenesis Inhibitors/administration & dosage , Antibodies, Monoclonal/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Colorectal Neoplasms/nursing , Antibodies, Monoclonal, Humanized , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Bevacizumab , Camptothecin/administration & dosage , Camptothecin/analogs & derivatives , Clinical Trials, Phase III as Topic/nursing , Colorectal Neoplasms/blood supply , Colorectal Neoplasms/drug therapy , Colorectal Neoplasms/mortality , Disease-Free Survival , Fluorouracil/administration & dosage , Humans , Leucovorin/administration & dosage , Randomized Controlled Trials as Topic/nursingSubject(s)
Carcinoma, Non-Small-Cell Lung/nursing , ErbB Receptors/antagonists & inhibitors , Lung Neoplasms/nursing , Protein Kinase Inhibitors/therapeutic use , Quinazolines/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Non-Small-Cell Lung/mortality , Clinical Trials, Phase III as Topic/nursing , Erlotinib Hydrochloride , Humans , Lung Neoplasms/drug therapy , Lung Neoplasms/mortality , Multicenter Studies as Topic , Protein Kinase Inhibitors/adverse effects , Quinazolines/adverse effects , Randomized Controlled Trials as Topic , Retreatment , Survival RateSubject(s)
Clinical Trials, Phase III as Topic/nursing , Neoplasms/therapy , Nurse Clinicians/organization & administration , Nurse's Role , Oncology Nursing/organization & administration , Research Personnel/organization & administration , Humans , National Institutes of Health (U.S.) , Pilot Projects , United StatesABSTRACT
Breast cancer is a major public health problem, with a 12% incidence among women. The over-expression of the proto-oncogene HER-2/neu is associated with 30% of breast and ovarian cancers that are very aggressive and do not respond to standard therapeutic regimens. Entrance into clinical trials can represent the best hope and even the last hope for these patients. Entrance, however, is based on satisfying eligibility criteria. In examining advanced stage breast cancer patients' access to phase III clinical trials for HER-2/neu, two specific arguments regarding eligibility will be addressed. First, if research is to provide the utilitarian goal of the 'greatest good to the greatest number', delineation of the population receiving the 'good', rather than a homogeneous sub-set of this population, must be addressed, along with patients' values and goals, very relevant to determining a 'good life', how to achieve it, and whether a treatment is a part of that process. Second, the 'good' being generated should involve realistic, practical values of quality ways of living with advanced breast cancer and not just increased survival, or cure. Arguments for relaxing criteria are based on an accurate versus over-simplified interpretation of utilitarian principles and concepts of human flourishing. Only through addressing these issues can the true 'good' of clinical trials and research be given to the greatest number of people.
Subject(s)
Antibodies, Monoclonal/therapeutic use , Antineoplastic Agents/therapeutic use , Breast Neoplasms/drug therapy , Clinical Trials, Phase III as Topic , Health Services Accessibility , Proto-Oncogene Proteins/immunology , Receptor, ErbB-2/immunology , Breast Neoplasms/genetics , Breast Neoplasms/nursing , Breast Neoplasms/pathology , Clinical Trials, Phase III as Topic/nursing , Clinical Trials, Phase III as Topic/standards , Female , Health Services Accessibility/standards , Humans , Neoplasm Staging , Patient Selection , Proto-Oncogene Mas , Research SubjectsABSTRACT
PURPOSE: Here we report the results of a randomized study undertaken to test the efficacy of a supplementary, telephone-based nursing intervention in increasing patients' awareness and understanding of the clinical trials in which they are asked to participate. METHODS: During a 12-month period, 180 cancer patients who were approached to participate in a phase II or III clinical trial were randomized to undergo either of the following: (1) standard informed consent procedures based on verbal explanations from the treating physician plus written information (controls); or (2) standard informed consent procedures plus a supplementary, telephone-based contact with an oncology nurse (intervention). For purposes of evaluation, face-to-face interviews were conducted with all patients approximately 1 week after the informed consent process had been completed. RESULTS: The two groups were comparable with regard to sociodemographic and clinical variables. Both groups had a high level of awareness of the diagnosis and of the nature and objectives of the proposed treatments. The intervention group was significantly (P < .01) better informed about the following: (1) the risks and side effects of treatment; (2) the clinical trial context of the treatment; (3) the objectives of the clinical trial; (4) where relevant, the use of randomization in allocating treatment; (5) the availability of alternative treatments; (6) the voluntary nature of participation; and (7) the right to withdraw from the clinical trial. The intervention did not have any significant effect on patients' anxiety levels or on rates of clinical trial participation. Patients reported high levels of satisfaction with the intervention. CONCLUSION: The use of a supplementary, telephone-based nursing intervention is a feasible and effective means to increase cancer patients' awareness and understanding of the salient issues that surround the clinical trials in which they are asked to participate.