Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Supportive Care in Cancer
Published in: Supportive Care in Cancer 10/2006

01-10-2006 | Special Article

The clinical significance of quality of life assessments in oncology: a summary for clinicians

Authors: Jeff A. Sloan, Marlene H. Frost, Rick Berzon, Amylou Dueck, Gordon Guyatt, Carol Moinpour, Mirjam Sprangers, Carol Ferrans, David Cella, Clinical Significance Consensus Meeting Group

Published in: Supportive Care in Cancer | Issue 10/2006

Login to get access

Abstract

Background

A series of six manuscripts with an introduction appeared in the Mayo Clinic Proceedings, based upon the collective effort of 30 individuals with an interest and expertise in assessing the clinical significance of quality of life (QOL) assessments. The series of manuscripts described the state of the science of QOL assessments in oncology clinical research and practice and included extensive literature and theoretical justification for the continued inclusion of QOL in oncology clinical research and practice.

Objectives

The purpose of this paper is to produce a summary of these articles and to supplement these works with additional information that was gleaned from subsequent meetings and discussions of this material. The primary aim of this paper is to present a cogent and concise description for clinicians to facilitate the incorporation of QOL assessments into oncology clinical research and practice. The theoretical discussion is supplemented with an example of how the various ideas can be operationalized in an oncology clinical trial.
Literature
1.
Bergman B, Aaronson NK, Ahmedzai S et al (1994) The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. Eur J Cancer 30A:635–642PubMedCrossRef
2.
Berzon RA (1994) Quality of life determinations in chronic conditions: perspectives of the pharmaceutical industry. In: Trimble MR, Dodson WE (eds) Epilepsy and quality of life. Raven, New York
3.
Brown DJ, McMillan DC, Milroy R (2005) The correlation between fatigue, physical function, the systemic inflammatory response, and psychological distress in patients with advanced lung cancer. Cancer 103:213–215CrossRef
4.
Cella DF (1996) Quality of life outcomes: measurement and validation. Oncology 10:233–246PubMed
5.
Cella DF, Tulsky DS, Gray G et al (1993) The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol 11:570–579PubMed
6.
Cella DF, Bonomi AE, Lloyd SR et al (1995) Reliability and validity of the Functional Assessment of Cancer Therapy–Lung (FACT-L) quality of life instrument. Lung Cancer 12:199–220PubMedCrossRef
7.
Cella D, Bullinger M, Scott C et al (2002) Group versus individual approaches to understanding the clinical significance of differences or changes in quality of life. Mayo Clin Proc 77:384–392PubMed
8.
Cella D, Eton DT, Fairclough DL et al (2002) What is a clinically meaningful change on the Functional Assessment of Cancer Therapy–Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) study 5592. J Clin Epidemiol 55:265–295CrossRef
9.
Cella D, Eton DT, Lai JS, Peterman AH, Merkel DE (2002) Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales. J Pain Symptom Manage 24:547–561PubMedCrossRef
10.
Chassany O, Sagnier P, Marquis P et al (2002) Patient-reported outcomes: the example of health-related quality of life—a European guidance document for the improved integration of health-related quality of life assessment in the drug regulatory process. Drug Inf J 36:209–238
11.
Cleeland CS, Ryan KM (1994) Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore 23:129–138PubMed
12.
Cohen J (1998) Statistical power analysis for the behavioral sciences, 2nd edn. Hillsdale, New Jersey
13.
Cortesi E, Gascon P, Henry D, Littlewood T, Milroy R, Pronzato P, Reinhardt U, Shasha D, Thatcher N, Wilkinson P (2005) Standard of care for cancer-related anemia: improving hemoglobin levels and quality of life. Oncology 68:22–32PubMedCrossRef
14.
Cox DR, Fitzpatrick R (1992) Quality-of-life assessment: can we keep it simple? J R Stat Soc 155:353–393CrossRef
15.
Cull A, Gould A, House A, Smith A, Strong V, Velikova G, Wright P, Selby P (2001) Validating automated screening for psychological distress by means of computer touchscreens for use in routine oncology practice. Br J Cancer 85:1842–1849PubMedCrossRef
16.
Curran SL, Andrykowski MA, Studts JL (1985) Short form of the profile of mood states (POMS-SF): psychometric information. Psychol Assess 7:80–83CrossRef
17.
Curt GA, Breitbart W, Cella D, Groopman JE, Horning SJ, Itri LM, Johnson DH, Miaskowski C, Scherr SL, Portenoy RK, Vogelzang NJ (2000) Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist 5:353–360PubMedCrossRef
18.
Davis K, Cella D (2002) Assessing quality of life in oncology clinical practice: a review of barriers and critical success factors. J Clin Outcomes Manag 9:327–332
19.
Detmar SB, Muller MJ, Schornagel JH, Wever LDV, Aaronson NK (2002) Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA 288:3027–3034PubMedCrossRef
20.
Donaldson GW, Moinpour CM (2002) Individual differences in quality of life treatment response. Med Care 40:III-39–III-53CrossRef
21.
Frost MH, Sloan JA (2002) Quality of life measurements: a soft outcome—or is it? Am J Manag Care 8:S574–S579PubMed
22.
Frost MH, Bonomi AE, Ferrans CE et al (2002) Patient, clinician, and population perspectives on determining the clinical significance of quality-of-life scores. Mayo Clin Proc 77:488–494PubMed
23.
Funch DP (1988) Predictors and consequences of symptom reporting behaviors in colorectal cancer patients. Med Care 26:1000–1008PubMedCrossRef
24.
Ganz P, Lee J, Siau J (1991) Quality of life assessment: an independent prognostic variable for survival in lung cancer. Cancer 67:3131–3135PubMedCrossRef
25.
Ganz PA, Moinpour CM, McCoy S (2004) Predictors of vitality (energy/fatigue) in early stage Hodgkin’s disease (HD): results from Southwest Oncology Group (SWOG) study 9133. J Clin Oncol 22:14S (abstract 6546)
26.
Greenhalgh J, Meadows K (1999) The effectiveness of the use of patient-based measures of health in routine practice in improving the process and outcomes of patient care: a literary review. J Eval Clin Pract 5:401–416PubMedCrossRef
27.
Groenvold M, Klee MC, Sprangers MAG et al (1997) Validation of the EORTC QLQ-C30 Quality of Life Questionnaire through combined qualitative and quantitative assessment of patient-observer agreement. J Clin Epidemiol 50:441–450PubMedCrossRef
28.
Guyatt GH, Osoba D, Wu AW et al (2002) Methods to explain the clinical significance of health status measures. Mayo Clin Proc 77:371–383PubMed
29.
Hollen PJ, Gralla RJ, Kris MG et al (1999) Normative data and trends in quality of life from the Lung Cancer Symptom Scale (LCSS). Support Care Cancer 7:140–148PubMedCrossRef
30.
Justice AC, Aiken LH, Smith HL et al (1996) The role of functional status in predicting inpatient mortality with AIDS: a comparison with current predictors. J Clin Epidemiol 49:193–201PubMedCrossRef
31.
Karnofsky DA (1967) Clinical evaluation of anticancer drugs. Gann Monogr Cancer Res 2:223–234
32.
Kazis LE, Anderson JJ, Meenan RF (1989) Effect sizes for interpreting changes in health status. Med Care 27:S178–S189PubMedCrossRef
33.
King MT (1996) The interpretation of scores from the EORTC Quality of Life Questionnaire QLQ-C30. Qual Life Res 5:555–567PubMedCrossRef
34.
Levinson W, Roter D (1995) Physicians’ psychosocial beliefs correlate with their patient communication skills. J Gen Intern Med 10:375–379PubMedCrossRef
35.
36.
McCorkle R, Cooley ME, Shea JA (1998) A user’s manual for the Symptom Distress Scale. University of Pennsylvania, Philadelphia
37.
Moinpour CM, Lyons B, Grevstad PK et al (2002) Quality of life in advanced non-small lung cancer: results of a Southwest Oncology Group randomized trial. Qual Life Res 11:115–126PubMedCrossRef
38.
Mor V, Laliberte L, Morris JN et al (1984) The Karnofsky Performance Status scale: an examination of its reliability and validity in a research setting. Cancer 53:2002–2007PubMedCrossRef
39.
Non-small Cell Lung Cancer Collaborative Group (1995) Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomized clinical trials. BMJ 311:899–909
40.
Norman GR, Gwadry Sridhar F et al (2001) The relation of distribution- and anchor-based approaches in interpretation of changes in health related quality of life. Med Care 39:1039–1047PubMedCrossRef
41.
Norman GR, Sloan JA, Wyrwich KW (2003) Interpretation of changes in health-related quality of life. The remarkable universality of a half a standard deviation. Med Care 41:582–592PubMedCrossRef
42.
Nunnally CC, Bernstein IH (1994) Psychometric theory, 3rd edn. McGraw-Hill, USA
43.
Osoba DA (2002) Taxonomy of the uses of health-related quality-of-life instruments in cancer care and the clinical meaningfulness of the results. Med Care 40:III-31–III-38CrossRef
44.
Osoba D, Rodrigues G, Myles J et al (1998) Interpreting the significance of changes in health-related quality of life scores. J Clin Oncol 16:139–144PubMed
45.
Schipper H, Clinch J, McMurray A et al (1984) Measuring the quality of life of cancer patients: the Functional Living Index–Cancer: development and validation. J Clin Oncol 2:472–483PubMed
46.
Sloan JA, Dueck A (2004) Issues for statisticians in conducting analyses and translating results for quality of life end points in clinical trials. J Biopharm Stat 14:73–96PubMedCrossRef
47.
Sloan JA, Loprinzi CL, Kuross SA et al (1998) Randomized comparison of four tools measuring overall quality of life in patients with advanced cancer. J Clin Oncol 16:3662–3673PubMed
48.
Sloan JA, Aaronson N, Cappelleri JC (2002) Assessing the clinical significance of single items relative to summated scores. Mayo Clin Proc 77:479–487PubMed
49.
Sloan JA, Cella D, Frost M et al (2002) Assessing clinical significance in measuring oncology patient quality of life: introduction to the symposium, content overview, and definition of terms. Mayo Clin Proc 77:367–370PubMed
50.
Sloan J, Symonds T, Vargas-Chanes D et al (2003) Practical guidelines for assessing the clinical significance of health-related quality of life changes within clinical trials. Drug Inf J 37:23–31
51.
Sloan JA, Vargas-Chanes D, Kamath CC et al (2003) Detecting worms, ducks and elephants: a simple approach for defining clinically relevant effects in quality-of-life measures. J Cancer Integ Med 1:41–47
52.
Spitzer WO, Dobson AJ, Hall J et al (1981) Measuring the quality of life of cancer patients: a concise QL-index for use by physicians. J Chronic Dis 34:585–597PubMedCrossRef
53.
Sprangers MAG, Moinpour CM, Moynihan TJ et al (2002) Assessing meaningful change in quality of life over time: a user’s guide for clinicians. Mayo Clin Proc 77:561–571PubMed
54.
Symonds T, Berzon R, Marquis P et al (2002) The clinical significance of quality-of-life results: practical considerations for specific audiences. Mayo Clin Proc 77:572–583PubMedCrossRef
55.
Tamburini M, Brunelli C, Rosso S et al (1996) Prognostic value of quality of life scores in terminal cancer patients. J Pain Symptom Manage 11:32–41PubMedCrossRef
56.
Taylor KM, Macdonald KG, Bezjak A, Ng P, DePetrillo AD (1996) Physicians’ perspective on quality of life: an exploratory study of oncologists. Qual Life Res 5:5–14PubMedCrossRef
57.
Unruh ML, Weisbord SD, Kimmel PL (2005) Health-related quality of life in nephrology research and clinical practice. Semin Dial 18:82–90PubMedCrossRef
58.
Valderas JM, Alonso J, Prieto L, Espallargues M, Castells X (2004) Content-based interpretation aids for health-related quality of life measures in clinical practice. An example for the Visual Function Index (VF-14). Qual Life Res 13:35–44PubMedCrossRef
59.
Velikova G, Brown JM, Smith AB, Selby PJ (2002) Computer-based quality of life questionnaires may contribute to doctor-patient interactions in oncology. Br J Cancer 86:51–59PubMedCrossRef
60.
Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, Selby PJ (2004) Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol 22:714–724PubMedCrossRef
61.
Ware JE, Kosinski M, Keller SD (1994) SF-36 physical and mental health summary scales: a user’s manual. Health Institute, New England Medical Center, Boston, Massachusetts
62.
Wright EP, Selby PJ, Crawford M, Gillibrand A, Johnston C, Perren TJ, Rush R, Smith A, Velikova G, Watson K, Gould A, Cull A (2003) Feasibility and compliance of automated measurement of quality of life in oncology practice. J Clin Oncol 21:374–382PubMedCrossRef
63.
Wyrwich KW, Nienaber NA, Tierney WM et al (1999) Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Med Care 37:469–478PubMedCrossRef
Metadata
Title
The clinical significance of quality of life assessments in oncology: a summary for clinicians
Authors
Jeff A. Sloan
Marlene H. Frost
Rick Berzon
Amylou Dueck
Gordon Guyatt
Carol Moinpour
Mirjam Sprangers
Carol Ferrans
David Cella
Clinical Significance Consensus Meeting Group
Publication date
01-10-2006
Publisher
Springer-Verlag
Published in
Supportive Care in Cancer / Issue 10/2006
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-006-0085-y

Other articles of this Issue 10/2006

Supportive Care in Cancer 10/2006 Go to the issue

Forthcoming Meetings

Forthcoming meetings

Original Article

Decision making in palliative radiation therapy: reframing hope in caregivers and patients with brain metastases

Short Communication

Biologically based complementary and alternative medicine use among breast cancer survivors: relationship to dietary fat consumption and exercise

Original Article

Clinical and economic impact of epoetin in adjuvant-chemotherapy for breast cancer

Editorial

Placing quality of life assessments on oncologists’ agenda

Original Article

A comparative study of living conditions in cancer patients who have returned to work after curative treatment
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine
Image Credits