Association of Breast Surgery at Baso 2009 Surgical guidelines for the management of breast cancer. Eur J Surg Oncol. 2009;35 Suppl 1:1-22. doi: 10.1016/j.ejso.2009.01.008. Epub 2009 Mar 18. No abstract available.
Braun DP, Gupta D, Grutsch JF, Staren ED Can changes in health related quality of life scores predict survival in stages III and IV colorectal cancer? Health Qual Life Outcomes. 2011 Aug 3;9:62. doi: 10.1186/1477-7525-9-62.
Earlam S, Glover C, Fordy C, Burke D, Allen-Mersh TG Relation between tumor size, quality of life, and survival in patients with colorectal liver metastases. J Clin Oncol. 1996 Jan;14(1):171-5. doi: 10.1200/JCO.1996.14.1.171.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG) Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0.
Edge SB, Compton CC The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNM. Ann Surg Oncol. 2010 Jun;17(6):1471-4. doi: 10.1245/s10434-010-0985-4.
Gotay CC, Kawamoto CT, Bottomley A, Efficace F The prognostic significance of patient-reported outcomes in cancer clinical trials. J Clin Oncol. 2008 Mar 10;26(8):1355-63. doi: 10.1200/JCO.2007.13.3439. Epub 2008 Jan 28.
Grande GE, Farquhar MC, Barclay SI, Todd CJ Quality of life measures (EORTC QLQ-C30 and SF-36) as predictors of survival in palliative colorectal and lung cancer patients. Palliat Support Care. 2009 Sep;7(3):289-97. doi: 10.1017/S1478951509990216. Erratum In: Palliat Support Care. 2009 Dec;7(4):533.
Gunderson LL, Jessup JM, Sargent DJ, Greene FL, Stewart AK Revised TN categorization for colon cancer based on national survival outcomes data. J Clin Oncol. 2010 Jan 10;28(2):264-71. doi: 10.1200/JCO.2009.24.0952. Epub 2009 Nov 30.
Hammond ME ASCO-CAP guidelines for breast predictive factor testing: an update. Appl Immunohistochem Mol Morphol. 2011 Dec;19(6):499-500. doi: 10.1097/PAI.0b013e31822a8eac.
Harbeck N, Sotlar K, Wuerstlein R, Doisneau-Sixou S Molecular and protein markers for clinical decision making in breast cancer: today and tomorrow. Cancer Treat Rev. 2014 Apr;40(3):434-44. doi: 10.1016/j.ctrv.2013.09.014. Epub 2013 Sep 29.
Johnson JR, Temple R Food and Drug Administration requirements for approval of new anticancer drugs. Cancer Treat Rep. 1985 Oct;69(10):1155-9.
Liossi C, White P, Hatira P A randomized clinical trial of a brief hypnosis intervention to control venepuncture-related pain of paediatric cancer patients. Pain. 2009 Apr;142(3):255-263. doi: 10.1016/j.pain.2009.01.017. Epub 2009 Feb 23.
Lis CG, Gupta D, Granick J, Grutsch JF Can patient satisfaction with quality of life predict survival in advanced colorectal cancer? Support Care Cancer. 2006 Nov;14(11):1104-10. doi: 10.1007/s00520-006-0100-3. Epub 2006 Jul 4.
McKernan M, McMillan DC, Anderson JR, Angerson WJ, Stuart RC The relationship between quality of life (EORTC QLQ-C30) and survival in patients with gastro-oesophageal cancer. Br J Cancer. 2008 Mar 11;98(5):888-93. doi: 10.1038/sj.bjc.6604248. Epub 2008 Feb 12.
Moinpour CM Do quality of life assessments make a difference in the evaluation of cancer treatments? Control Clin Trials. 1997 Aug;18(4):311-7. doi: 10.1016/s0197-2456(97)00054-8.
Montazeri A Quality of life data as prognostic indicators of survival in cancer patients: an overview of the literature from 1982 to 2008. Health Qual Life Outcomes. 2009 Dec 23;7:102. doi: 10.1186/1477-7525-7-102.
Montgomery GH, Schnur JB, Kravits K Hypnosis for cancer care: over 200 years young. CA Cancer J Clin. 2013 Jan;63(1):31-44. doi: 10.3322/caac.21165. Epub 2012 Nov 20.
Montgomery GH, Weltz CR, Seltz M, Bovbjerg DH Brief presurgery hypnosis reduces distress and pain in excisional breast biopsy patients. Int J Clin Exp Hypn. 2002 Jan;50(1):17-32. doi: 10.1080/00207140208410088.
Osoba D, Rodrigues G, Myles J, Zee B, Pater J Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998 Jan;16(1):139-44. doi: 10.1200/JCO.1998.16.1.139.
Osoba D Translating the science of patient-reported outcomes assessment into clinical practice. J Natl Cancer Inst Monogr. 2007;(37):5-11. doi: 10.1093/jncimonographs/lgm002.
Osoba D What has been learned from measuring health-related quality of life in clinical oncology. Eur J Cancer. 1999 Oct;35(11):1565-70. doi: 10.1016/s0959-8049(99)00192-6.
Redd WH, Montgomery GH, DuHamel KN Behavioral intervention for cancer treatment side effects. J Natl Cancer Inst. 2001 Jun 6;93(11):810-23. doi: 10.1093/jnci/93.11.810.
Rodary C, Leplege A, Hill C [Evaluation of the quality of life in clinical research in cancerology]. Bull Cancer. 1998 Feb;85(2):140-8. French.
Schmoll HJ, Twelves C, Sun W, O'Connell MJ, Cartwright T, McKenna E, Saif M, Lee S, Yothers G, Haller D Effect of adjuvant capecitabine or fluorouracil, with or without oxaliplatin, on survival outcomes in stage III colon cancer and the effect of oxaliplatin on post-relapse survival: a pooled analysis of individual patient data from four randomised controlled trials. Lancet Oncol. 2014 Dec;15(13):1481-1492. doi: 10.1016/S1470-2045(14)70486-3. Epub 2014 Nov 12.
Trask PC, Hsu MA, McQuellon R Other paradigms: health-related quality of life as a measure in cancer treatment: its importance and relevance. Cancer J. 2009 Sep-Oct;15(5):435-40. doi: 10.1097/PPO.0b013e3181b9c5b9.
Wazir U, Mokbel K Emerging gene-based prognostic tools in early breast cancer: First steps to personalised medicine. World J Clin Oncol. 2014 Dec 10;5(5):795-9. doi: 10.5306/wjco.v5.i5.795.
Zaniboni A, Labianca R, Marsoni S, Torri V, Mosconi P, Grilli R, Apolone G, Cifani S, Tinazzi A GIVIO-SITAC 01: A randomized trial of adjuvant 5-fluorouracil and folinic acid administered to patients with colon carcinoma--long term results and evaluation of the indicators of health-related quality of life. Gruppo Italiano Valutazione Interventi in Oncologia. Studio Italiano Terapia Adiuvante Colon. Cancer. 1998 Jun 1;82(11):2135-44. doi: 10.1002/(sici)1097-0142(19980601)82:113.0.co;2-u.
Zelen M Randomized consent designs for clinical trials: an update. Stat Med. 1990 Jun;9(6):645-56. doi: 10.1002/sim.4780090611.
Prospective, Randomized Study Aiming to Assess the Benefit of Autohypnosis Learning in the Care of Patients Treated by Adjuvant Chemotherapy for Colorectal or Breast Cancer.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.