Integrating patient-reported outcomes into cancer symptom management clinical trials supported by the National Cancer Institute-sponsored clinical trials networks

Journal of Clinical Oncology

Volumn 25, Issue 32, 2007, Pages 5070-5077

  Sloan, Jeff A ^a   Berk, Lawrence ^a   Roscoe, Joseph ^a   Fisch, Michael J ^a   Shaw, Edward G ^a   Wyatt, Gwen ^a   Morrow, Gary R ^a   Dueck, Amylou C ^a  

^a MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA TOCOPHEROL; ANTIDEPRESSANT AGENT; ANTINEOPLASTIC AGENT; BISPHOSPHONIC ACID DERIVATIVE; CORTICOSTEROID; DONEPEZIL; GINGER EXTRACT; MEGESTROL ACETATE; OXALIPLATIN; PAROXETINE; PLACEBO; RECOMBINANT ERYTHROPOIETIN; SAMARIUM 153; SEROTONIN UPTAKE INHIBITOR; STRONTIUM 89; SUCRALFATE; VENLAFAXINE;

ANALGESIA; BONE METASTASIS; BRAIN METASTASIS; BRAIN RADIATION; BRAIN TUMOR; CANCER FATIGUE; CANCER PATIENT; CANCER RADIOTHERAPY; CANCER RESEARCH; CLINICAL TRIAL; COGNITION; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; DRUG LABELING; HEAD AND NECK CANCER; HEALTH CARE ORGANIZATION; HOT FLUSH; HUMAN; LUNG CANCER; MOOD; NAUSEA; NEOPLASM; OUTCOME ASSESSMENT; PAIN ASSESSMENT; PATIENT CARE; PERIPHERAL NEUROPATHY; PRIORITY JOURNAL; QUALITY OF LIFE; RADIATION DOSE FRACTIONATION; RADIOFREQUENCY ABLATION; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; STOMATITIS; TREATMENT OUTCOME;

ACTIVITIES OF DAILY LIVING; CLINICAL TRIALS AS TOPIC; HUMANS; NATIONAL CANCER INSTITUTE (U.S.); NEOPLASMS; PATIENT SATISFACTION; QUALITY INDICATORS, HEALTH CARE; QUALITY OF LIFE; SICKNESS IMPACT PROFILE; TREATMENT OUTCOME; UNITED STATES;

EID: 36849010940     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2007.12.7670     Document Type: Conference Paper

References (49)

1. Bottomley A, Vanvoorden V, Fletchner H, et al: The challenges and achievements involved in implementing QOL research in cancer clinical trials. Eur J Cancer 39:275-285, 2003
2. Osoba DA: Taxonomy of the uses of healthrelated quality-of-life instruments in cancer care and the clinical meaningfulness of the results. Med Care 40:III31-III38, 2002
3. Lipscomb J, Gotay CC, Snyder C: Outcomes Assessment in Cancer: Measures, Methods, and Applications. Cambridge, United Kingdom, Cambridge University Press, 2005
4. Sloan JA: Challenges in QOL assessment: Overview and introduction. Curr Probl Cancer 29:274-277, 2005
5. US Food and Drug Administration: Patientreported outcome measures: Use in medical product development to support labeling claims. http://www.fda.gov/ cder/guidance/5460dft.pdf
6. Sloan JA, Halyard M, Frost M, et al: The FDA guidance for patient-reported outcomes: What does it mean and how will it impact clinical trials? Val Health 10:S59-S146, 2007
7. Fayers PM, Hopwood P, Harvey A, et al: Quality of life assessment in clinical trials: Guidelines and a checklist for protocol writers - The U.K. Medical Research Council Experience. Eur J Cancer 33:20-28, 1997
8. Gotay CC, Korn EL, McCabe MS, et al: Quality-of-life assessment in cancer treatment protocols: Research issues in protocol development. J Natl Cancer Inst 84:575-579, 1992
9. Fairclough DL: Design and Analysis of Quality of Life Studies in Clinical Trials. New York, NY, CRC Press, 2002
10. Dancey J, Zee B, Osoba D, et al: Quality of life scores: An independent prognostic variable in a general population of cancer patients receiving chemotherapy - The National Cancer Institute of Canada Clinical Trials Group. Qual Life Res 6:151-158, 1997
11. Fayers P, Hays R: Assessing Quality of Life in Clinical Trials. New York, NY, Oxford University Press, 2005
12. Sloan JA, Dueck A: Issues for statisticians in conducting analyses and translating results for quality of life end points in clinical trials. J Biopharm Stat 14:73-96, 2004
13. Staquet MJ, Berzon RA, Osoba D, et al: Guidelines for reporting results of quality of life assessments in clinical trials, in Staquet MJ, Hays RD, Fayers PM (eds): Quality of Life Assessment in Clinical Trials. New York, NY, Oxford University Press, 1998
14. Symonds T, Berzon R, Marquis P, et al: Clinical significance of quality of life results: Practical considerations for specific audiences. Mayo Clin Proc 77:572-583, 2002
15. Buchanan DR, White JD, O'Mara AM, et al: Research-design issues in cancer-symptom-management trials using complementary and alternative medicine: Lessons from the National Cancer Institute Community Clinical Oncology Program experience. J Clin Oncol 23:6682-6689, 2005
16. Tong D, Gillick L, Hendrickson FR: The palliation of symptomatic osseous metastases: Final results of the study by the Radiation Therapy Oncology Group. Cancer 50:893-899, 1982
17. Salazar OM, Rubin P, Hendrickson FR, et al: Single-dose half-body irradiation for palliation of multiple bone metastases from solid tumors: Final Radiation Therapy Oncology Group report. Cancer 58:29-36, 1986
18. Scarantino CW, Caplan R, Rotman M, et al: A phase I/II study to evaluate the effect of fractionated hemibody irradiation in the treatment of osseous metastases: RTOG 88-22. Int J Radiat Oncol Biol Phys 36:37-48, 1996
19. Hartsell WF, Scott CB, Bruner DW, et al: Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst 97:798-804, 2005
20. Cleeland CS, Ryan KM: Pain assessment: Global use of the Brief Pain Inventory. Ann Acad Med Singapore 23:129-138, 1994
21. Cella DF, Tulsky DS, Gray G, et al: The Functional Assessment of Cancer Therapy scale: Development and validation of the general measure. J Clin Oncol 11:570-579, 1993
22. Feeny D, Furlong W, Barr RD: Multiattribute approach to the assessment of health-related quality of life: Health Utilities Index. Med Pediatr Oncol 1:54-59, 1998 (suppl)
23. Krabbe PF, Peerenboom L, Langenhoff BS, et al: Responsiveness of the generic EQ-5D summary measure compared to the disease-specific EORTC QLQ C-30. Qual Life Res 13:1247-1253, 2004
24. Borgelt B, Gelber R, Kramer S, et al: The palliation of brain metastases: Final results of the first two studies by the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys 6:1-9, 1980
25. Regine WF, Schmitt FA, Scott CB, et al: Feasibility of neurocognitive outcome evaluations in patients with brain metastases in a multi-institutional cooperative group setting: Results of Radiation Therapy Oncology Group trial BR-0018. Int J Radiat Oncol Biol Phys 58:1346-1352, 2004
26. McQuellon RP, Moose DB, Russell GB, et al: Supportive use of megestrol acetate (Megace) with head/ neck and lung cancer patients receiving radiation therapy. Int J Radiat Oncol Biol Phys 52:1180-1185, 2002
27. Farmer M, Case D, Lesser G, et al: A phase III double blind placebo controlled prospective randomized trial on the effect of megestrol acetate on weight and health-related quality of life in lung cancer and head/neck cancer patients receiving definitive radiation therapy. Int J Radiat Oncol Biol Phys 63:S77, 2005 (abstr)
28. Witzig TE, Silberstein PT, Loprinzi CL, et al: Phase III, randomized, double-blind study of epoetin alfa compared with placebo in anemic patients receiving chemotherapy. J Clin Oncol 23:2606-2617, 2005
29. Sloan JA, Loprinzi CL, Novotny PJ, et al: Methodological lessons learned from hot flash studies. J Clin Oncol 19:4280-4290, 2001
30. Barton D, Loprinzi C, Quella S, et al: Prospective evaluation of vitamin E for hot flashes in breast cancer survivors. J Clin Oncol 16:495-500, 1998
31. Finck G, Barton DL, Loprinzi CL, et al: Definitions of hot flashes in breast cancer survivors. J Pain Symptom Manage 16:327-333, 1998
32. Carpenter JS: State of the science: Hot flashes and cancer. Part 1: Definition, scope, impact, physiology, and measurement. Oncol Nurs Forum 32:959-968, 2005
33. Cleeland CS, Mendoza TR, Wang XS, et al: Assessing symptom distress in cancer patients: The M.D. Anderson Symptom Inventory. Cancer 89:1634-1646, 2000
34. Morrow GR, Roscoe JA, Hickok JT, et al: Nausea and emesis: Evidence for a biobehavioral perspective. Support Care Cancer 10:96-105, 2002
35. Morrow GR, Hickock JT, Roscoe JA, et al: Differential effects of paroxetine on fatigue and depression: A randomized, double-blind trial from the University of Rochester Cancer Center Community Clinical Oncology Program. J Clin Oncol 21:4635-4641, 2003
36. Sloan JA, Aaronson N, Cappelleri JC, et al: Assessing the clinical significance of single items relative to summated scores. Mayo Clin Proc 77:479-487, 2002
37. Locke D, Sloan JA, Novotny PJ, et al: Validation of and normative data for simple single-item numerical analogue self-assessments for quality of life. J Pain Symptom Manage [epub ahead of print on August 20, 2007]
38. Goldberg RM, Sargent DJ, Morton RF, et al: A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 22:23-30, 2004
39. Martenson JA, Bollinger JW, Sloan JA, et al: Sucralfate in the prevention of treatment-induced diarrhea in patients receiving pelvic radiation therapy: A North Central Cancer Treatment Group phase III double-blind placebo-controlled trial. J Clin Oncol 18:1239-1245, 2000
40. Loprinzi C, Kugler J, Sloan J, et al: Venlafaxine in management of hot flashes in survivors of breast cancer: A randomised controlled trial. Lancet 356:2059-2063, 2000
41. Shaw EG, Rosdhal R, D'Agostino RB Jr, et al: A phase II study of donepezil in irradiated brain tumor patients: Effect on cognitive function, mood, and quality of life. J Clin Oncol 24:1415-1420, 2006
42. Weitzner MA, Meyers CA, Gelke C, et al: The Functional Assessment of Cancer Therapy (FACT) scale: Development of a brain subscale and revalidation of the general version (FACT-G) in patients with primary brain tumors. Cancer 75:1151-1161, 1995
43. Curran SL, Andrykowski MA, Studts JL: Short Form of the Profile of Mood States (POMS-SF): Psychometric information. Psychol Assess 7:80-83, 1995
44. Dodd MJ, Miaskowski C, Lee KA: Occurrence of symptom clusters. J Natl Cancer Inst Monogr 32:76-78, 2004
45. Saconn PA, Ip E, Rapp S, et al: Symptom clusters in irradiated brain tumor survivors. J Clin Oncol 24:488s, 2006 (suppl; abstr 8581)
46. Fairclough D, Peterson HF, Chang V: Why are missing quality of life data a problem in clinical trials of cancer therapy? Stat Med 17:667-677, 1998
47. Huntington JL, Dueck A: Handling missing data. Curr Probl Cancer 29:317-325, 2005
48. Goetz MP, Callstrom MR, Charboneau JW, et al: Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: A multicenter study. J Clin Oncol 22:300-306, 2004
49. Dillman DA: Mail and Internet Surveys: The Tailored Design Method. New York, NY, John Wiley & Sons, 2000