Comparison of provider-assessed and patient-reported outcome measures of acute skin toxicity during a Phase III trial of mometasone cream versus placebo during breast radiotherapy: The North Central Cancer Treatment Group (N06C4)

International Journal of Radiation Oncology Biology Physics

Volumn 81, Issue 2, 2011, Pages 397-402

  Neben Wittich, Michelle A ^a   Atherton, Pamela J ^a   Schwartz, David J ^b   Sloan, Jeff A ^a   Griffin, Patricia C ^c   Deming, Richard L ^d   Anders, Jon C ^e   Loprinzi, Charles L ^a   Burger, Kelli N ^a   Martenson, James A ^a   Miller, Robert C ^a  

^a MAYO CLINIC   (United States)

^b Minneapolis Radiation Oncology   (United States)

^c Upstate Carolina CCOP   (United States)

^d Iowa Oncology Research Association CCOP   (United States)

^e WICHITA COMMUNITY CLINICAL ONCOLOGY PROGRAM   (United States)

Author keywords

Breast; Dermatitis; Mometasone; Patient reported outcomes; Radiation

Indexed keywords

ADVERSE EVENTS; BREAST; BREAST RADIOTHERAPY; CLINICAL TRIAL; INTEROBSERVER VARIABILITY; MOMETASONE; PATIENT-REPORTED OUTCOMES; PEARSON CORRELATION COEFFICIENTS; SKIN TOXICITY; STATISTICAL CORRELATION; SUBJECTIVE SYMPTOMS;

CORRELATION METHODS; DERMATITIS; HEAT RADIATION; TOXICITY;

RADIOTHERAPY;

MOMETASONE FUROATE; PLACEBO;

ADULT; ARTICLE; BREAST CANCER; BURN; CANCER RADIOTHERAPY; COMPARATIVE STUDY; CONTROLLED STUDY; ERYTHEMA; HUMAN; HYPOPIGMENTATION; MAJOR CLINICAL STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RADIATION DERMATITIS; SELF REPORT; SKIN ATROPHY; SKIN IRRITATION; STRIA; TREATMENT OUTCOME;

BREAST NEOPLASMS; COMMUNICATION; DERMATOLOGIC AGENTS; ERYTHEMA; FEMALE; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PREGNADIENEDIOLS; PROSPECTIVE STUDIES; PRURITUS; QUALITY OF LIFE; RADIODERMATITIS; TREATMENT OUTCOME;

EID: 80052786611     PISSN: 03603016     EISSN: 1879355X     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2010.05.065     Document Type: Article

References (25)

1. A. Trotti, A.D. Colevas, and A. Setser CTCAE v3.0: Development of a comprehensive grading system for the adverse effects of cancer treatment Semin Radiat Oncol 13 2003 176 181 (Pubitemid 36962641)
2. D.W. Bruner, C.J. Bryan, and N. Aaronson National Cancer Institute. Issues and challenges with integrating patient-reported outcomes in clinical trials supported by the National Cancer Institute-sponsored clinical trials networks J Clin Oncol 25 2007 5051 5057 (Pubitemid 350232283)
3. J.A. Sloan, L. Berk, and J. Roscoe National Cancer Institute. Integrating patient-reported outcomes into cancer symptom management clinical trials supported by the National Cancer Institute-sponsored clinical trials networks J Clin Oncol 25 2007 5070 5077 (Pubitemid 350232285)
4. M.D. Brundage, J.L. Pater, and B. Zee Assessing the reliability of two toxicity scales: Implications for interpreting toxicity data J Natl Cancer Inst 85 1993 1138 1148 (Pubitemid 23212280)
5. H. Kaba, H. Fukuda, S. Yamamoto, and Y. Ohashi [Reliability at the National Cancer Institute-Common Toxicity Criteria version 2.0] [in Japanese] Gan To Kagaku Ryoho 31 2004 1187 1192
6. E. Basch, D. Artz, and D. Dulko Patient online self-reporting of toxicity symptoms during chemotherapy J Clin Oncol 23 2005 3552 3561
7. M.B. Parliament, C.E. Danjoux, and T. Clayton Is cancer treatment toxicity accurately reported? Int J Radiat Oncol Biol Phys 11 1985 603 608 (Pubitemid 15124080)
8. J. Lipscomb, B.B. Reeve, and S.B. Clauser Patient-reported outcomes assessment in cancer trials: taking stock, moving forward J Clin Oncol 25 2007 5133 5140 (Pubitemid 350232295)
9. D. Tong, L. Gillick, and F.R. Hendrickson The palliation of symptomatic osseous metastases: Final results of the Study by the Radiation Therapy Oncology Group Cancer 50 1982 893 899 (Pubitemid 12047122)
10. D.E. Locke, P.A. Decker, and J.A. Sloan Validation of single-item linear analog scale assessment of quality of life in neuro-oncology patients J Pain Symptom Manage 34 2007 628 638 (Pubitemid 350161248)
11. R.P. McQuellon, D.B. Moose, G.B. Russell, L.D. Case, K. Greven, and M. Stevens Supportive use of megestrol acetate (Megace) with head/neck and lung cancer patients receiving radiation therapy Int J Radiat Oncol Biol Phys 52 2002 1180 1185 (Pubitemid 34296478)
12. T.E. Witzig, P.T. Silberstein, and C.L. Loprinzi Phase III, randomized, double-blind study of epoetin alfa compared with placebo in anemic patients receiving chemotherapy J Clin Oncol 23 2005 2606 2617 (Pubitemid 46179449)
13. C.S. Cleeland, T.R. Mendoza, and X.S. Wang Assessing symptom distress in cancer patients: The M.D. Anderson Symptom Inventory Cancer 89 2000 1634 1646
14. F.M. Fang, W.L. Tsai, and H.C. Chiu Quality of life as a survival predictor for esophageal squamous cell carcinoma treated with radiotherapy Int J Radiat Oncol Biol Phys 58 2004 1394 1404
15. J.A. Sloan Challenges in QOL assessment: Overview and introduction Curr Probl Cancer 29 2005 274 277
16. J.A. Sloan, M.Y. Halyard, and M.H. Frost Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group. The Mayo Clinic manuscript series relative to the discussion, dissemination, and operationalization of the Food and Drug Administration guidance on patient-reported outcomes Value Health 10 Suppl. 2 2007 S59 S63
17. C.C. Gotay, J. Lipscomb, and C.F. Snyder Reflections on findings of the Cancer Outcomes Measurement Working Group: Moving to the next phase J Natl Cancer Inst 97 2005 1568 1574 (Pubitemid 41662710)
18. Miller RC, Schwartz DJ, Sloan JA, et al. Mometasone furoateeffect on acute skin toxicity in breast cancer patients receiving radiotherapy: A Phase 3 double-blind, randomized trial from the North Central Cancer Treatment Group N06C4. Int J Radiat Oncol Biol Phys. In press.
19. J.A. Sloan, and A. Dueck Issues for statisticians in conducting analyses and translating results for quality of life end points in clinical trials J Biopharm Stat 14 2004 73 96 (Pubitemid 38294753)
20. M. Palazzi, S. Tomatis, E. Orlandi, M. Guzzo, C. Sangalli, and P. Potepan Effects of treatment intensification on acute local toxicity during radiotherapy for head and neck cancer: Prospective observational study validating CTCAE, version 3.0, scoring system Int J Radiat Oncol Biol Phys 70 2008 330 337
21. M.M. Huschka, S.J. Mandrekar, and P.L. Schaefer A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials Cancer 109 2007 787 795 (Pubitemid 46233242)
22. D. Revicki, R.D. Hays, D. Cella, and J. Sloan Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes J Clin Epidemiol 61 2008 102 109
23. U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: Use in medical product development to support labeling claims: draft guidance Health Qual Life Outcomes 4 2006 79
24. National Cancer Institute. Outcomesresearch. Cancer control and population sciences: Patient-reported outcomes version of the CTCAE (PRO-CTCAE) [updated September 28, 2009]. Available at: http://www.outcomes.cancer.gov/ tools/pro-ctcae.html. Accessed December 23, 2009.
25. E. Basch, A. Iasonos, and T. McDonough Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: Results of a questionnaire-based study Lancet Oncol 7 2006 903 909 (Pubitemid 44615944)