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:4/29/2017)... ... April 29, 2017 , ... TransDark is a set ... one video to the next without having to set a single keyframe in ... to enhance your video production. , TransDark features dynamic transitions that momentarily splits the ...
(Date:4/28/2017)... (PRWEB) , ... April 28, 2017 , ... An April 24th article on ... stunning 180 pounds with the help of a weight loss surgery. The woman, declaring “I ... skin that have been left following her dramatic weight loss. Dr. Feiz & Associates notes ...
(Date:4/28/2017)... , ... April 28, 2017 , ... Beginning in 2017, ... their formulas. This begins with the popular ClearLungs Extra Strength formula. To ensure that ... the formula in the following ways:, , Removal of the ...
(Date:4/28/2017)... ... April 28, 2017 , ... Ushio America ... lamps offer an instant energy-saving solution for F32T8 fluorescent lamps on most instant-start ... ballasts. These 50,000 hour rated lamps utilize the existing electronic ballast, saving labor ...
(Date:4/28/2017)... ... April 28, 2017 , ... From ... College of Urgent Care Medicine will host industry leaders for the annual spring ... help those in the industry adapt to the issues currently affecting urgent care ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... 20, 2017  Cogentix Medical, Inc. (NASDAQ: CGNT), ... the Urology, Uro/Gyn and Gynecology markets with innovative ... has joined the Company as Senior Vice President, ... position, Mr. Keswani will report directly to ... "Our organization is delighted that Ash has joined ...
(Date:4/20/2017)... , April 20, 2017  RXi Pharmaceuticals Corporation ... therapeutics that address significant unmet medical needs, today ... the Company,s consumer product development program, based on ... Society for Investigative Dermatology (SID) 76 th ... and promote the sciences relevant to skin health ...
(Date:4/20/2017)... , April 20, 2017  AbbVie (NYSE: ... 99 percent (n=145/146) of chronic hepatitis C virus ... 5 or 6 and compensated cirrhosis (Child-Pugh A) ... (SVR 12 ) with its investigational, pan-genotypic regimen ... rates were seen following 12 weeks of G/P ...
Breaking Medicine Technology: