Quality of life in breast cancer patients: measurement issues in cancer clinical trials

References

• Kong SX, Ghandi SK. Methodologic assessments of quality of life measures in clinical trials. Ann. Pharmacother. 31,830–836 (1997).
   PubMed Web of Science ®Google Scholar
• Velikova G, Stark D, Selby P Quality of Life Instruments in Oncology. Eur Cancer35(11), 1571–1580 (1999).
   PubMedGoogle Scholar
• •A comprehensive review describing the current state of the development and application of QoL instruments in cancer clinical research.
   Google Scholar
• Bottomley A. Quality of Life Assessment. Applied Clinical Trials, January 1–5 (2001).
   Google Scholar
• Hietanen PS. Measurement and practical aspects of quality of life in breast cancer. Acta Oncol 35(1), 39–42 (1996).
   PubMedGoogle Scholar
• Holland JC, Kash KM, Passik S et al. A brief spiritual beliefs inventory for use in quality of life research in life-threatening illness. PTchooncology7(6), 460–469 (1998).
   PubMed Web of Science ®Google Scholar
• Brady MJ, Peterman AH, Fitchett G, May MO, Cella D. A case for including spirituality in quality of life measurement in oncology. Fiychooncology (8)5,417–428 (1999).
   PubMed Web of Science ®Google Scholar
• Mytko J, Knight S. Body, mind and spirit: towards the integration of religiosity and spirituality in cancer quality of life research. Psychooncology (8)5,439–450 (1999).
   PubMed Web of Science ®Google Scholar
• Cotton SP, Levine EG, Fitzpatrick CM, Dold KH, Targ E. Exploring the relationships among spiritual well-being, quality of life and psychological adjustment in women with breast cancer. Fiychooncology8(5), 429–438 (1999).
   PubMed Web of Science ®Google Scholar
• Moinpour CM. Measuring quality of life: an emerging science. Semin. Oncol. (5 Suppl. 10), 48–60 (1994).
   Google Scholar
• Aaronson NK, Ahmedzai S, Bergman B et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J. Nall Cancer Inst. 85 (5), 365–376 (1993). iiMandelblatt JS, Eisenberg JM. Historical and methodological perspectives on cancer outcomes research. Oncology 9 (11 Suppl.), 23–32 (1995).
   Google Scholar
• Moinpour CM, Savage MJ, Troxel A et al. Quality of Life in Advanced Prostate Cancer: Results of a Randomized Therapeutic Trial. j Nati Cancer Inst. 90(20), 1537–1544 (1998).
   Google Scholar
• Feld R. End points in cancer clinical trials: is there a need for measuring quality of life? Support. Cam Cancer3, 23–27 (1995).
   Google Scholar
• Payne SA. A study of quality of life in cancer patients receiving palliative chemotherapy. Soc. Sci. Med. 35(12), 1505–1509 (1992).
   Google Scholar
• Bernhard J, Gusset H, Hurny C. Quality of life assessment in cancer clinical trials: an intervention by itself? Support. Cam Cancer 3,66–71 (1995).
   Google Scholar
• Fayers PM, Jones DR. Measuring and analysing quality of life in cancer clinical trials: a review. Stat. Med. 2,429–446 (1983).
   PubMedGoogle Scholar
• Boring CC, Squires TS, Tong T, Montgomery S. Cancer Statistics, 1994. Cancer 1 Clin. 44(1), 7–26 (1994).
   Google Scholar
• Holzner B, Kemmler G, Kopp M et al. Quality of life in breast cancer patients-not enough attention for long-term survivors? Psychosomatics 42 (2), 117–123 (2001).
   Google Scholar
• Fallowfield U. Assessment of quality of life in breast cancer. Acta Oncol. 34(5), 689–694 (1995).
   Google Scholar
• Ferrell BR, Grant M, Funk B, Otis-Green S, Garcia N. Quality of life in breast cancer. Part I: Physical and social well-being. Cancer NUTS. 20(6), 398–408 (1997).
   Google Scholar
• Velanovich V, Szymanski W Quality of life of breast cancer patients with lymphedema. Am. Surg. 177(3), 184–187 (1999).
   Google Scholar
• Dorval M, Maunsell E, Deschenes L, Brisson J, Masse B. Long-term quality of life after breast cancer: comparison of 8-year survivors with population controls. Clin. Oncol 16(2), 487–494 (1998).
   Google Scholar
• •An interesting paper addressing long-term QoL issues in breast patients.
   Google Scholar
• Curran D, van Dongen JP, Aaronson NK et al. Quality of life of early-stage breast cancer patients treated with radical mastectomy or breast-conserving procedures: results of EORTC Trial 10801. The European Organization for Research and Treatment of Cancer (EORTC), Breast Cancer Co-operative Group (BCCG) . Eur. Cancer 34 (3), 307–314 (1998).
   Google Scholar
• Gilbar O, Ungar L, Fried G, Taller Y, Cohen M, Robinson E. Living with mastectomy and breast conservation treatment: who suffers more? Support. Cam Cancer5(4), 322–326 (1997).
   Google Scholar
• Kiebert GM, de Haes JC, van de Velde CJ. The impact of breast-conserving treatment and mastectomy on the quality of life of early-stage breast cancer patients: a review. J. Clin. Oncol 9(6), 1059–1070 (1991).
   Google Scholar
• Fallowfield U. Quality of life measurement in breast cancer. R. Soc. Med. 86,10–12 (1993).
   Google Scholar
• Ganz PA, Schag AC, Lee JJ, Polinsky ML, Tan SJ. Breast conservation versus mastectomy. Is there a difference in psychological adjustment or quality of life in the year after surgery? Cancer 69(7), 1729–1738 (1992).
   Google Scholar
• Poulsen B, Graversen HP, Beckmann J, Blichert-Toft M. A comparative study of post-operative psychosocial function in women with primary operable breast cancer randomized to breast conservation therapy or mastectomy. Eur j Surg: Oncol. 23(4), 327–334 (1997).
   PubMed Web of Science ®Google Scholar
• Fung KW Lau Y, Fielding R, Or A, Yip M. The impact of mastectomy, breast-conserving treatment and immediate breast reconstruction on the quality of life of Chinese women. ANZ I Surg:71(4), 202–206 (2001).
   Google Scholar
• Amichetti M, Caffo 0. Quality of life in patients with early stage breast carcinoma treated with conservation surgery and radiotherapy. An Italian monoinstitutional study. Tumori 87 (2), 78–84 (2001) .
   Google Scholar
• Wapnir IL, Cody RP, Greco RS. Subtle differences in quality of life after breast cancer surgery. Ann. Surg: Oncol 6(4), 359–366 (1999).
   Google Scholar
• King MT, Kenny P, Shiell A, Hall J, Boyages J. Quality of life three months and one year after first treatment for early stage breast cancer: influence of treatment and patient characteristics. Qual Life Res. 9(7), 789–800 (2000).
   PubMed Web of Science ®Google Scholar
• Wilkins EG, Lowery JC, Kuzon WM, Perkins MS. Functional outcomes in postmastectomy breast reconstruction: preliminary results of the Michigan Breast Reconstruction Outcomes study. Surg: Forum48, 609–612 (1997).
   Google Scholar
• Dorval M, Maunsell E, Deschenes L, Brisson J. Type of mastectomy and quality of life for long-term breast carcinoma survivors. Cancer 83 (10), 2130–2138 (1998).
   PubMedGoogle Scholar
• Irwig L, Bennetts A. Quality of life after breast conservation or mastectomy: a systematic review. Aust. NZJ Surg: 67(11), 750–754 (1997).
   PubMedGoogle Scholar
• Nissen MJ, Swenson KIK, Ritz LJ, Farrell JB, Sladek ML, Lally RM. Quality of life after breast carcinoma surgery: a comparison of three surgical procedures. Cancer91 (7), 1238–1246 (2001).
   PubMedGoogle Scholar
• Riccardi A, Tinelli C, Brugnatelli S et al. Doubling of the epirubicin dosage within the 5-fluorouracil, epirubicin and cyclophosphamide regimen: a prospective, randomized, multicentric study on antitumor effect and quality of life in advanced breast cancer. Int. j Oncol 16(4), 769–776 (2000).
   Google Scholar
• Coates A, Gebski V, Bishop JF et al Improving the quality of life during chemotherapy for advanced breast cancer. A comparison of intermittent and continuous treatment strategies. N Eng/. I Med. 317(24), 1490–1495 (1987).
   Google Scholar
• Day R, Ganz PA, Costantino JP, Cronin WM, Wickerham DL, Fisher B. Health-related quality of life and tamoxifen in breast cancer prevention: a report from the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J. Clin. Oncol 17(9), 2659–2669 (1999).
   Google Scholar
• Levine MN, Guyatt GH, Gent M et al. Quality of life in stage II breast cancer: an instrument for clinical trials. J. Clin. Oncol 6(12), 1798–1810 (1988).
   Google Scholar
• Arora NK, Gustafson DH, Hawkins RP et al Impact of surgery and chemotherapy on the quality of life of younger women with breast carcinoma: a prospective study. Cancer92(5), 1288–1298 (2001).
   PubMed Web of Science ®Google Scholar
• Shimozuma K, Ganz PA, Petersen L, Hirji K. Quality of life in the first year after breast cancer surgery: rehabilitation needs and patterns of recovery. Breast Cancer Res. Brat. 56(1), 45–57 (1999).
   Google Scholar
• Dow IKH, Lafferty P Quality of life, survivorship and psychosocial adjustment of young women with breast cancer after breast-conserving surgery and radiation therapy. Oncol NUTS. Forum 27(10), 1555–1564 (2000).
   Google Scholar
• Bottomley A. Quality of life data interpretation: Key issues in advanced breast cancer. In: Breast Cancer Management. Application of evidence to patient cam Nabholtz JM, Tonkin K, Aapro MS, Buzdar A (Ed.), Martin Dunitz Ltd, London, UK, 363–372 (2000).
   Google Scholar
• Staquet M, Berzon R, Osoba D, Machin D. Guidelines for reporting results of quality of life assessments in clinical trials. Qual life Res. 5(5), 496–502 (1996).
   Google Scholar
• ••Interesting methodology paper dealing with guidelines for reporting QoL outcomes in cancer clinical trials.
   Google Scholar
• Ware JE, Jr., Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med. Cate 30(6), 473–483 (1992).
   Google Scholar
• McHorney CA, Ware JE, Jr., Lu JF, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions and reliability across diverse patient groups. Med. Cam 32(1), 40–66 (1994).
   Google Scholar
• McHorney CA, Ware JE, Jr., Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med. Cam 31(3), 247–263 (1993).
   Google Scholar
• Fayers P, Machin D. Quality of Life. Assessment, Analysis and Interpretation. (Ed.), John Wiley & Sons, Chichester, UK (2000).
   Google Scholar
• Rustoen T, Begnum S. Quality of life in women with breast cancer: a review of the literature and implications for nursing practice. Cancer NUTS. 23 (6), 416–421 (2000).
   Google Scholar
• Janni W, Rjosk D, Dimpfl TH et al Quality of life influenced by primary surgical treatment for stage I-III breast cancer-long-term follow-up of a matched-pair analysis. Ann. Sing. Oncol 8(6), 542–548 (2001).
   Google Scholar
• te Velde A, Sprangers MA, Aaronson NK. Feasibility, psychometric performance and stability across modes of administration of the CARES-SF Ann. Oncol 7(4), 381–390 (1996).
   Google Scholar
• de Haes JC, van Knippenberg FC, Neijt JR Measuring psychological and physical distress in cancer patients: structure and application of the Rotterdam Symptom Checklist. Br. Cancer 62 (6), 1034–1038 (1990).
   Google Scholar
• Hopwood P, Howell A, Maguire P. Screening for psychiatric morbidity in patients with advanced breast cancer: validation of two self-report questionnaires. Br. Cancer64(2), 353–356 (1991).
   Google Scholar
• Paci E. Assessment of validity and clinical application of an Italian version of the Rotterdam Symptom Checklist. Qual Life Res. 1(2), 129–134 (1992).
   Google Scholar
• Agra Y, Badia X. Spanish version of the Rotterdam Symptom Check List: cross-cultural adaptation and preliminary validity in a sample of terminal cancer patients. Ptychooncology7(3), 229–239 (1998).
   PubMedGoogle Scholar
• Bosnjak S, Radulovic S, Neskovic- Konstantinovic Z, Mitrovic L. Patient statement of satisfaction with anti-emetic treatment is related to quality of life. Am. J. Clin. Oncol 23(6), 575–578 (2000).
   Google Scholar
• Hall A, AHem R, Fallowfield L. Are we using appropriate self-report questionnaires for detecting anxiety and depression in women with early breast cancer? Eur Cancer35(1), 79–85 (1999).
   Google Scholar
• de Haes JC, Olschewski M. Quality of life assessment in a cross-cultural context: use of the Rotterdam Symptom Checklist in a multinational randomised trial comparing CMF and Zoladex (Goserlin) treatment in early breast cancer. Ann. Oncol 9(7), 745–750 (1998).
   PubMedGoogle Scholar
• Schag CA, Ganz PA, Heinrich RL. Cancer Rehabilitation Evaluation System-short form (CARES-SF): A cancer specific rehabilitation and quality of life instrument. Cancer68(6), 1406–1413 (1991).
   PubMed Web of Science ®Google Scholar
• Schag CA, Heinrich RL, Ganz PA. The cancer inventory of problem situations: An instrument for assessing cancer patient's rehabilitation needs. J. Ptychosoc. Oncol 1, 11–24 (1983).
   Google Scholar
• Schag CA, Heinrich RL. Cancer Rehabilitation Evaluation System (CARES) Manual, 1st Edition. Los Angeles: CARES Consultants (1989).
   Google Scholar
• Hanson Frost M, Suman VJ, Rummans TA et al Physical, psychological and social well-being of women with breast cancer: the influence of disease phase. Ptychooncology 9 (3), 221–231 (2000) .
   PubMed Web of Science ®Google Scholar
• Schipper H, Clinch J, McMurray A, Levitt M. Measuring the quality of life of cancer patients: the Functional Living Index-Cancer: development and validation.' Clin. Oncol 2(5), 472–483 (1984).
   Google Scholar
• Holland JC, Romano SJ, Heiligenstein JH, Tepner RG, Wilson MG. A controlled trial of fluoxetine and desipramine in depressed women with advanced cancer. fiychooncology7(4), 291–300 (1998).
   PubMed Web of Science ®Google Scholar
• Chu L, Sutton LM, Peterson BL, Havlin IKA, Winer ER Continuous infusion 5-fluorouracil as first-line therapy for metastatic breast cancer. J. Infus. Chemother. 6(4), 211–216 (1996).
   Google Scholar
• Marchioro G, Azzarello G, Checchin F, et al. The impact of a psychological intervention on quality of life in non-metastatic breast cancer. Eur. J. Cancer 32A(9), 1612–1615 (1996).
   Google Scholar
• Fairclough DL, Fetting JH, Cella D, Wonson W Moinpour CM. Quality of life and quality adjusted survival for breast cancer patients receiving adjuvant therapy. Eastern Co-operative Oncology Group (ECOG). Qual Life Res 8(8), 723–731 (1999).
   Google Scholar
• Whelan TJ, Levine M, Julian J, Kirkbride P, Skingley P The effects of radiation therapy on quality of life of women with breast carcinoma: results of a randomized trial. Ontario Clinical Oncology Group. Cancer 88(10), 2260–2266 (2000).
   PubMed Web of Science ®Google Scholar
• 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(3), 570–579 (1993).
   Google Scholar
• Brady MJ, Cella DF, Mo F et al. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J. Clin. Oncol. 15 (3), 974–986 (1997).
   Google Scholar
• Richardson MA, Post-White J, Grimm EA, Moye LA, Singletary SE, Justice B. Coping, life attitudes and immune responses to imagery and group support after breast cancer treatment. Altern. Ther. Health Med. 3(5), 62–70 (1997).
   Google Scholar
• Bonomi AE, Cella DF, Hahn EA et al Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Qual Life Res. 5(3), 309–320 (1996).
   Google Scholar
• Blazeby J, Sprangers M, Cull A, Groenvold M, Bottomley A. EORTC Quality of Life Group. Guidelines for Developing Questionnaire Modules. (Ed.), (3rd edition) EORTC, Brussels, Belgium (2001).
   Google Scholar
• Sprangers MA, Groenvold M, Arraras JI et al. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study.j Clin. Oncol. 14(10), 2756–2768 (1996).
   Google Scholar
• ••A detailed international validation study of a specific QoL tool for breast patients.
   Google Scholar
• Kissane DW, Clarke DM, Ikin J et al Psychological morbidity and quality of life in Australian women with early-stage breast cancer: a cross-sectional survey. Med. J. Aust. 169(4), 192–196 (1998).
   Google Scholar
• Cull A, Sprangers M, Bjordal K, Aaronson M. EORTC Quality of Life Study Gorup. Translation Procedure. (Ed.) EORTC, Brussels, Belgium (1998).
   Google Scholar
• Klee MC, King MT, Machin D, Hansen HH. A clinical model for quality of life assessment in cancer patients receiving chemotherapy. Ann. Onco1.11(1), 23–30 (2000).
   Google Scholar
• Hakamies-Blomqvist L, Luoma ML, Sjostrom J et al Timing of quality of life (QoL) assessments as a source of error in oncological trials. J. Adv. NUTS. 35(5), 709–716 (2001).
   Google Scholar
• Velikova G, Wright EP, Smith AB et al Automated collection of quality-of-life data: a comparison of paper and computer touch-screen questionnaires. J. Clin. Oncol. 17(3), 998–1007 (1999).
   Google Scholar
• Cull A, Gould A, House A et al Validating automated screening for psychological distress by means of computer touchscreens for use in routine oncology practice. BE J. Cancer 85(12), 1842–1849 (2001).
   Google Scholar