Abstract
Objectives There is a need for a brief symptom index for advanced kidney cancer that includes perspectives of both patients and clinicians and is consistent with the Food and Drug Administration's guidance for patient-reported outcome measures. This study developed and examined the preliminary reliability and validity of the new National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19. Methods Fifty patients with advanced kidney cancer provided open-ended and survey responses ranking their most important symptoms. Responses were reconciled with published clinician reports of the most important symptoms. Ten experienced oncologists rated symptoms as disease- or treatment-related. Patients completed quality-of-life and performance status measures. Results A 19-item index was produced from symptoms that were rated as most important by patients or clinicians. It includes three subscales: disease-related symptoms (DRS), treatment side effects (TSE), and general function and well-being (FWB). Internal consistency was good for the full instrument (α = 0.83), the DRS subscale (α = 0.76), and the FWB subscale (α = 0.78) but lower for the TSE subscale (α = 0.59). Convergent validity was demonstrated through correlations with the FACT-General. Patients with differing performance status were distinguished by the total score (F2,47 = 17.37; P <.0001), the DRS subscale (F2,47 = 14.22; P <.0001), and the FWB subscale (F2,47 = 13.40; P <.0001) but not the TSE subscale (F 2,47 =1.48; P = 0.2380). Conclusions The National Comprehensive Cancer Network/FACT-Kidney Symptom Index 19 combines symptoms deemed most important by patients and clinicians. Preliminary evidence suggests that the total score and DRS and FWB subscales are reliable and valid as summary indexes. The TSE subscale may be least relevant given the advent of newer therapies.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 789-796 |
| Number of pages | 8 |
| Journal | Value in Health |
| Volume | 16 |
| Issue number | 5 |
| DOIs | |
| State | Published - Jul 2013 |
Funding
Source of financial support: Support for the study was provided by grants from the following pharmaceutical companies: Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Centocor, Cell Therapeutics, Inc., Genentech, GlaxoSmithKline, Eli Lilly and Company, Merck & Co., Novartis, Ortho Biotech, Pfizer, Sanofi-Aventis, and Takeda Pharmaceuticals. The contents represent original work. Dr. Abernethy has research funding from the US National Institutes of Health, US Agency for Healthcare Research and Quality, Robert Wood Johnson Foundation, Biovex, DARA, Helsinn, MiCo, and Pfizer; these funds are all distributed to Duke University Medical Center to support research including salary support for Dr. Abernethy. In the last 2 years, she has had nominal consulting agreements with or received honoraria from (<$5000 annually) Novartis and Pfizer. Consulting with Bristol Meyers Squibb is pending in 2012, for role as Co-Chair of a Scientific Advisory Committee. Dr. Abernethy has paid leadership roles with American Academy of Hospice & Palliative Medicine (President-Elect) and Pillars4Life (Medical Director) in 2013. She has corporate leadership responsibility in Advoset (an education company that has a contract with Novartis) and Orange Leaf Associates LLC (an IT development company).
Keywords
- cancer
- patient-reported outcomes
- quality of life
- symptoms
ASJC Scopus subject areas
- Public Health, Environmental and Occupational Health
- Health Policy
