US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer

David Cella, Arijit Ganguli, James Turnbull, Jeffrey Rohay, Robert Morlock, David Cella, Arijit Ganguli, James Turnbull, Jeffrey Rohay, Robert Morlock

Abstract

Introduction: The patient experience with prostate cancer differs throughout the disease continuum, with health-related quality of life (HRQoL) and symptoms worsening as the disease progresses. To understand the prostate cancer experience, it is important to understand the experience of same-aged men without prostate cancer as a basis for comparison. This study provides the US population reference values for six patient-reported outcome (PRO) questionnaires.

Methods: A cross-sectional online survey, including several PRO questionnaires, was administered in 2019 to a representative sample of US adults. The male sample (N = 876) was raked by age to have similar characteristics of men in key advanced prostate cancer trials (mean/median age: 67.5/70.0 years), with the majority being white and non-Hispanic.

Results: Results from six PRO questionnaires (Brief Pain Inventory; Quality of Life in Neurological Disorders 2.0 Cognitive Short Form; PRO Measurement Information System Fatigue-Short Form; Functional Assessment of Cancer Therapy-General; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Cancer Module) indicated that the US representative sample of men have good role, physical, and emotional functioning but slightly impaired social, functional, and overall well-being. In addition, they have normal cognitive function, few financial problems, minimal pain and fatigue, minimal urinary and bowel symptoms, and limited use of incontinence aids.

Conclusions: The availability of the reference values for these PRO questionnaires will enable researchers to compare the HRQoL of patients with advanced prostate cancer in the US with that of the general US population and allow for a better interpretation of those scores. Registration numbers of advanced prostate cancer trials: NCT02677896, NCT02003924, NCT01212991, NCT00974311.

Keywords: BPI; EORTC; FACT; Health-related quality of life questionnaires; Norms; Prostate cancer reference values.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study sample flow chart

References

    1. National Cancer Institute. SEER Cancer statistics factsheets: prostate cancer. 2015. . Accessed Jan 2016.
    1. Aggarwal RR, Feng FY, Small EJ. Emerging categories of disease in advanced prostate cancer and their therapeutic implications. Oncology (Williston Park) 2017;31:467–474.
    1. Tomaszewski EL, Moise P, Krupnick RN, et al. Symptoms and impacts in non-metastatic castration-resistant prostate cancer: qualitative study findings. Patient. 2017;10:567–578. doi: 10.1007/s40271-017-0227-y.
    1. Holmstrom S, Naidoo S, Turnbull J, Hawryluk E, Paty J, Morlock R. Symptoms and impacts in metastatic castration-resistant prostate cancer: qualitative findings from patient and physician interviews. Patient. 2019;12:57–67. doi: 10.1007/s40271-018-0349-x.
    1. Nussbaum N, George DJ, Abernethy AP, et al. Patient experience in the treatment of metastatic castration-resistant prostate cancer: state of the science. Prostate Cancer Prostatic Dis. 2016;19:111–121. doi: 10.1038/pcan.2015.42.
    1. Naidoo S, Paty J, Fickley C, et al. Enhancing interpretation of patient-reported outcome scores through intuitive metrics: an example from prostate cancer. Value Health. 2016;19(3):A160. doi: 10.1016/j.jval.2016.03.1479.
    1. Armstrong AJ, Szmulewitz RZ, Petrylak DP, et al. ARCHES: a randomized, phase III study of androgen deprivation therapy with enzalutamide or placebo in men with metastatic hormone-sensitive prostate cancer. J Clin Oncol. 2019;37:2974–2986. doi: 10.1200/JCO.19.00799.
    1. Chi KN, Protheroe A, Rodriguez-Antolin A, et al. Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): an international, randomised phase 3 trial. Lancet Oncol. 2018;19:194–206. doi: 10.1016/S1470-2045(17)30911-7.
    1. Agarwal N, McQuarrie K, Bjartell A, et al. Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2019;20:1518–1530. doi: 10.1016/S1470-2045(19)30620-5.
    1. Sternberg CN, Fizazi K, Saad F, et al. Enzalutamide and survival in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2020;382:2197–2206. doi: 10.1056/NEJMoa2003892.
    1. Saad F, Cella D, Basch E, et al. Effect of apalutamide on health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the SPARTAN randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018;19:1404–1416. doi: 10.1016/S1470-2045(18)30456-X.
    1. Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014;371:424–433. doi: 10.1056/NEJMoa1405095.
    1. Cella D, Traina S, Li T, et al. Relationship between patient-reported outcomes and clinical outcomes in metastatic castration-resistant prostate cancer: post hoc analysis of COU-AA-301 and COU-AA-302. Ann Oncol. 2018;29:392–397. doi: 10.1093/annonc/mdx759.
    1. Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367:1187–1197. doi: 10.1056/NEJMoa1207506.
    1. Kretschmer A, Ploussard G, Heidegger I, et al. Health-related quality of life in patients with advanced prostate cancer: a systematic review. Eur Urol Focus. 2021;7:742–751. doi: 10.1016/j.euf.2020.01.017.
    1. Van Hemelrijck M, Sparano F, Moris L, et al. Harnessing the patient voice in prostate cancer research: systematic review on the use of patient-reported outcomes in randomized controlled trials to support clinical decision-making. Cancer Med. 2020;9:4039–4058. doi: 10.1002/cam4.3018.
    1. 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. 1993;11:570–579. doi: 10.1200/JCO.1993.11.3.570.
    1. Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983;17:197–210. doi: 10.1016/0304-3959(83)90143-4.
    1. National Institute of Neurological Disorders and Stroke (NINDS)User Manual for the Quality of Life in Neurological DisordersA(Neuro-QoL)Q4 Measures, Version 2.0. . Accessed Mar 2015.
    1. Patient-Reported Outcomes Measures Information System.Scoring Manual for the PROMIS Fatigue Measure. . Accessed Feb 2019.
    1. Cella D.Manual of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System, Version 4.1. Center on Outcomes, Research & Education (CORE); Evanston, IL (2004). Accessed 14 June 2022.
    1. Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A. The EORTC QLQ-C30 scoring manual. 3. Brussels: European Organisation for Research and Treatment of Cancer; 2001.
    1. van Andel G, Bottomley A, Fosså SD, et al. An international field study of the EORTC QLQ-PR25: a questionnaire for assessing the health-related quality of life of patients with prostate cancer. Eur J Cancer. 2008;44:2418–2424. doi: 10.1016/j.ejca.2008.07.030.
    1. Moreh E, Jacobs JM, Stessman J. Fatigue, function, and mortality in older adults. J Gerontol A Biol Sci Med Sci. 2010;65:887–895. doi: 10.1093/gerona/glq064.
    1. Zis P, Daskalaki A, Bountouni I, Sykioti P, Varrassi G, Paladini A. Depression and chronic pain in the elderly: links and management challenges. Clin Interv Aging. 2017;12:709–720. doi: 10.2147/CIA.S113576.
    1. Mahler DA. Evaluation of dyspnea in the elderly. Clin Geriatr Med. 2017;33:503–521. doi: 10.1016/j.cger.2017.06.004.
    1. Patel D, Steinberg J, Patel P. Insomnia in the elderly: a review. J Clin Sleep Med. 2018;14:1017–1024. doi: 10.5664/jcsm.7172.
    1. Nolte S, Liegl G, Petersen MA, et al. General population normative data for the EORTC QLQ-C30 health-related quality of life questionnaire based on 15,386 persons across 13 European countries, Canada and the Unites States. Eur J Cancer. 2019;107:153–163. doi: 10.1016/j.ejca.2018.11.024.
    1. Curran D, Fossa S, Aaronson N, Kiebert G, Keuppens F, Hall R. Baseline quality of life of patients with advanced prostate cancer. European Organization for Research and Treatment of Cancer (EORTC), Genito-Urinary Tract Cancer Cooperative Group (GUT-CCG) Eur J Cancer. 1997;33:1809–1814. doi: 10.1016/S0959-8049(97)00187-1.
    1. Jenkins V, Solis-Trapala I, Payne H, et al. Treatment experiences, information needs, pain and quality of life in men with metastatic castrate-resistant prostate cancer: results from the EXTREQOL study. Clin Oncol (R Coll Radiol) 2019;31:99–107. doi: 10.1016/j.clon.2018.11.001.
    1. Rodriguez Antolin A, Martinez-Pineiro L, Jimenez Romero ME, et al. Prevalence of fatigue and impact on quality of life in castration-resistant prostate cancer patients: the VITAL study. BMC Urol. 2019;19:92. doi: 10.1186/s12894-019-0527-8.
    1. Ryan C, Wefel JS, Morgans AK. A review of prostate cancer treatment impact on the CNS and cognitive function. Prostate Cancer Prostatic Dis. 2020;23:207–219. doi: 10.1038/s41391-019-0195-5.
    1. Feng LR, Regan J, Shrader JA, et al. Cognitive and motor aspects of cancer-related fatigue. Cancer Med. 2019;8:5840–5849. doi: 10.1002/cam4.2490.
    1. Wang X, Hui Y, Wang S, et al. Comparison of effectiveness and safety outcomes of abiraterone versus enzalutamide in patients with metastatic castration-resistant prostate cancer: a systematic review and meta-analysis. J Pharm Pharm Sci. 2020;23:451–461. doi: 10.18433/jpps31003.

Source: PubMed

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