Navigation Links
Quality of life measures in breast cancer clinical trials
Date:1/7/2011

Quality of life measures tend to be most useful for clinical decision-making in trials in which quality of life is the primary outcome, according to a recent study published online January 7 in The Journal of the National Cancer Institute.

There has been increasing interest in the value of patient-reported symptom assessment in trials and their potential usage as primary or secondary endpoints in new trials. Both the World Health Organization and the U.S. Food and Drug Administration have endorsed quality of life, but they are not always incorporated into trials because of the additional resources needed for data collection. But quality of life measures remain important for women who have completed therapy and many have symptoms such as fatigue, cognitive complaints, sleep and sexual problems, and neuropathy. At the other end of the spectrum, for advanced breast cancer patients on palliative treatments with toxicities, it would be important to determine if any observed survival benefit is outweighed by that burden.

To determine how quality of life measures are used in clinical trials, Julie Lemieux, M.D., of the Universit Laval in Qubec, Canada, and colleagues, conducted a literature search for articles that reported a randomized clinical trial of breast cancer treatment in which quality of life was an endpoint.

Their review included 190 randomized clinical trials103 on biomedical interventions, and 87 on non-biomedical interventions, such as psychosocial interventions like the effect of group therapy on patient outcomes.

The authors found that QOL measures were most useful for clinical decisions in trials using non-biomedical interventions.

They also found that quality of life measurements should be included as a secondary endpoint in adjuvant therapy trials only when the medical outcome is expected to be about the same, or if the study focuses on a vulnerable population such as the elderly; or tests a new intervention for which quality of life information needs to be obtained. They should also be included in metastatic breast cancer trials when a minimal survival difference is expected; or treatments have substantial differences in toxicity.

They also write that when QOL is not the primary endpoint of a trial, "QOL results should ideally appear in a companion article published at the same time as the traditional medical outcomes article so that a full view of the risks and benefits of the intervention can be presented at the same time to clinicians."

In an accompanying editorial, Patricia A. Ganz, M.D., of UCLA, writes, "The large increase in the number of published studies identified in this high-quality systematic review reflects the increased acceptance of the patient's voice in assessing the outcome of trials as well as the participation of expert QOL investigators in the design, conduct, and analysis of clinical trials."

Ganz also writes, "Inclusion of well-validated measures of relevant symptoms should be a high priority for assessing the burden of breast cancer treatments, whether in survivors of breast cancer or in women with advanced disease receiving palliative care."


'/>"/>

Contact: Kristine Crane
jncimedia@oxfordjournals.org
301-841-1285
Journal of the National Cancer Institute
Source:Eurekalert

Related medicine news :

1. Quality of Life Key Measure in Breast Cancer Clinical Trials
2. Researchers measure quality of care in oral anticoagulation
3. Better Methods Needed to Measure Hospital Quality: Experts
4. Mortality rates are an unreliable metric for assessing hospital quality, study finds
5. James W. Varnum National Quality Award presented to Project SEARCH
6. Active surveillance for low-risk prostate cancer may offer better quality-of-life
7. Professor Zvi Ram presents phase III recurrent glioblastoma survival and quality of life data from the first pivotal study of the NovoTTF-100A at 15th Annual Society for Neuro-Oncology Scientific Meeting
8. Lung cancer patients are the centerpiece for Northwestern medicine quality of care study
9. Poor sleep quality increases inflammation, community study finds
10. Penn study: Hospital CPR quality is worse at night
11. Higher medication spending doesnt indicate better prescribing quality
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... Las Vegas, Nevada (PRWEB) , ... October 13, 2017 , ... ... of 7® Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum ... CBD dose required and providing a CBD form that can be easily incorporated into ...
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association (VNA) of Somerset ... of specialty vendors and unique items from across the nation, this holiday-themed event will ... services offered by the VNA. The boutique will be open Saturday, November 4 ...
(Date:10/13/2017)... , ... October 13, 2017 , ... ... and Agile Software Development, has been awarded a contract by the Center for ... Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies in a ...
(Date:10/12/2017)... LA (PRWEB) , ... October 12, 2017 , ... Planet ... in the U.S., announced today its plans to open a flagship location in Covington, ... occupy the former Rooms To Go store next to Office Depot in the Holiday ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... delivery system that we intend to develop to enable prevention of a major ... to severe hearing loss, especially in pediatric patients. For cisplatin, hearing loss is ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... Mich. , Oct. 2, 2017 Diplomat ... 8th Day Software and Consulting, LLC , and ... 8th Day Software, based in Tennessee ... LLC. 8th Day expands EnvoyHealth,s service offerings for health ... development. "In an ...
(Date:10/2/2017)... , Oct. 2, 2017 Halo Labs announces the ... analysis system called the HORIZON at MIBio 2017 in ... subvisible and visible particulate matter in biopharmaceutical samples with unprecedented speed ... of the novel technique Backgrounded Membrane Imaging. ... The HORIZON subvisible particle analysis system ...
(Date:9/28/2017)... , Sept. 28, 2017 Cohen Veterans Bioscience ... the use of wearable and home sensors for real-time ... Early Signal Foundation, a nonprofit organization focused on disruptive ... provide an affordable analytical system to record and integrate ... ...
Breaking Medicine Technology: