Top

Supportive Care in Cancer

Published in:

Open Access 01-11-2019 | Urothelial Cancer | Original Article

Validity and performance of the Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) among advanced urothelial cancer patients

Authors: Arnold Degboe, Cristina Ivanescu, Jeffrey M. Rohay, Ralph R. Turner, David Cella

Published in: Supportive Care in Cancer | Issue 11/2019

Abstract

Purpose

The recent increase in emerging novel therapies in the bladder cancer therapeutic area has increased the need for fit-for-purpose patient-reported outcome (PRO) measures for these patients. This study evaluates the psychometric properties of the Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) in 182 patients with advanced urothelial cancer (UC) and fills an important gap by demonstrating its validity for use in clinical trials.

Methods

Data were collected as part of a multicentre, open-label study of durvalumab in patients with inoperable or metastatic solid tumours. Psychometric properties evaluated include item and subscale characteristics (including correlation analysis), reliability (estimated using Cronbach’s α), validity (by independent sample t test), responsiveness (using mixed models with repeated measures), and clinically meaningful changes using both anchor-based and distribution-based methods.

Results

One hundred and seventy-two patients completed the FACT-Bl questionnaire at baseline. Many individual items had floor or ceiling effects indicative of minimal symptoms and high functioning. The psychometric properties of the existing established scales were assessed and found to range from acceptable to very good. Internal consistency (most Cronbach’s α coefficients range 0.66–0.85) and stability (test–retest reliability) generally exceeded standards for good reliability (most estimated intraclass correlations [ICCs] exceeded 0.70, although ICCs for some items [e.g. emotional well-being, ICC 0.58; social well-being, ICC 0.66] were lower than 0.70). Evidence for known-group validity of relevant FACT-Bl subscales and total score was demonstrated by significant differences between groups defined by baseline tumour burden and quality of life scores (difference of FACT-Bl total between low/high tumour burden groups 11.72 (p = 0.001); difference between low/high QoL scores groups 30.51 (p < 0.0001)). The FACT-Bl subscale and total scores were responsive to changes in bladder cancer symptom severity. Clinically meaningful changes in FACT-Bl scores were estimated.

Conclusions

Results support the use of the FACT-Bl within this patient population in future clinical research.

Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A (2018) Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 68(6):394–424. https://doi.org/10.3322/caac.21492 CrossRef

Leppert JT, Shvarts O, Kawaoka K, Lieberman R, Belldegrun AS, Pantuck AJ (2006) Prevention of bladder cancer: a review. Eur Urol 49(2):226–234. https://doi.org/10.1016/j.eururo.2005.12.011 CrossRefPubMed

Bladder cancer: introduction. https://www.cancer.net/cancer-types/bladder-cancer/introduction. Accessed 27 Feb 2019

Allareddy V, Kennedy J, West MM, Konety BR (2006) Quality of life in long-term survivors of bladder cancer. Cancer 106(11):2355–2362. https://doi.org/10.1002/cncr.21896 CrossRefPubMed

Jensen SE, Beaumont JL, Jacobsen PB, Abernethy A, Syrjala KL, Cella D (2013) Measuring priority symptoms in advanced bladder cancer: development and initial validation of a brief symptom index. J Support Oncol 11(2):86–93. https://doi.org/10.1016/j.suponc.2012.07.002 CrossRefPubMedPubMedCentral

Jacobs BL, Lee CT, Montie JE (2010) Bladder cancer in 2010: how far have we come? CA Cancer J Clin 60(4):244–272. https://doi.org/10.3322/caac.20077 CrossRefPubMed

Gacci MSO, Cai T, Gore JL, D’Elia C, Minervini A, Masieri L, Giannessi C, Lanciotti M, Varca V, Simonato A, Serni S, Carmignani G, Carini M (2013) Quality of life in women undergoing urinary diversion for bladder cancer: results of a multicenter study among long-term disease-free survivors. Health Qual Life Outcomes 11:43CrossRef

Zahran MH, Taha DE, Harraz AM, Zidan EM, El-Bilsha MA, Tharwat M, El Hefnawy AS, Ali-El-Dein B (2017) Health related quality of life after radical cystectomy in women: orthotopic neobladder versus ileal loop conduit and impact of incontinence. Minerva Urol Nefrol 69(3):262–270. https://doi.org/10.23736/S0393-2249.16.02742-9 CrossRefPubMed

Davarpanah NN, Yuno A, Trepel JB, Apolo AB (2017) Immunotherapy: a new treatment paradigm in bladder cancer. Curr Opin Oncol 29:184–195. https://doi.org/10.1097/cco.0000000000000366 CrossRefPubMedCentral

10.

Howie LJ SH, King-Kallimanis B, Roydhouse J, Theoret MR, Blumenthal GM, et al (2018) Patient-reported outcomes in PD-1/PD-L1 inhibitor registration trials: FDA analysis of data submitted and future directions. J Clin Oncol 36(Suppl 5S):Abstr 134CrossRef

11.

Danna BJ, Metcalfe MJ, Wood EL, Shah JB (2016) Assessing symptom burden in bladder cancer: an overview of bladder cancer specific health-related quality of life instruments. Bladder Cancer 2(3):329–340. https://doi.org/10.3233/BLC-160057 CrossRefPubMedPubMedCentral

12.

Tung-Ming LBE, Galsky M, Latini DM, Goltz HH, Lee CT, Quale DZ, Jensen BT, Girgis A, Given BA, Modamed NE (2017) Examining the psychometric properties of the bladder cancer needs assessment surgery. JOJ Urol Nephron 4(1). https://doi.org/10.19080/JOJUN.2017.4.555627

13.

Gopalakrishna A, Longo TA, Fantony JJ, Harrison MR, Inman BA (2017) Physical activity patterns and associations with health-related quality of life in bladder cancer survivors. Urol Oncol 35(9):540 e541–540 e546. https://doi.org/10.1016/j.urolonc.2017.04.016 CrossRef

14.

Herman JMSD, Montie J, Hayman JA, Sullivan MA, Kent E, Griffith KA, Esper P, Sandler HM (2004) Prospective quality-of-life assessment in patients receiving concurrent gemcitabine and radiotherapy as a bladder preservation strategy. Urology 64(1):69–73. https://doi.org/10.1016/j.urology.2004.02.024 CrossRefPubMed

15.

Kikuchi E, Horiguchi Y, Nakashima J, Ohigashi T, Oya M, Nakagawa K, Miyajima A, Murai M (2006) Assessment of long-term quality of life using the FACT-BL questionnaire in patients with an ileal conduit, continent reservoir, or orthotopic neobladder. Jpn J Clin Oncol 36(11):712–716. https://doi.org/10.1093/jjco/hyl094 CrossRefPubMed

16.

Li MY, Yang YL, Liu L, Wang L (2016) Effects of social support, hope and resilience on quality of life among Chinese bladder cancer patients: a cross-sectional study. Health Qual Life Outcomes 14:73. https://doi.org/10.1186/s12955-016-0481-z CrossRefPubMedPubMedCentral

17.

Food and Drug Administration (2009) Guidance for industry, patient-reported outcome measures: use in medical product development to support labeling claims. U.S. Department of Health and Human Services, Silver Spring, MD

18.

Powles T, O’Donnell PH, Massard C, Arkenau HT, Friedlander TW, Hoimes CJ, Lee JL, Ong M, Sridhar SS, Vogelzang NJ, Fishman MN, Zhang J, Srinivas S, Parikh J, Antal J, Jin X, Gupta AK, Ben Y, Hahn NM (2017) Efficacy and safety of durvalumab in locally advanced or metastatic urothelial carcinoma: updated results from a phase 1/2 open-label study. JAMA Oncol 3(9):e172411. https://doi.org/10.1001/jamaoncol.2017.2411 CrossRefPubMedPubMedCentral

19.

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC et al (1993) 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 Natl Cancer Inst 85(5):365–376CrossRef

20.

Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J et al (1993) The Functional Assessment of Cancer Therapy Scale: development and validation of the general measure. J Clin Oncol 11(3):570–579. https://doi.org/10.1200/jco.1993.11.3.570 CrossRefPubMed

21.

FACT-Bl (Version 4). www.facit.org/LiteratureRetrieve.aspx?ID=42242. Accessed 27 Feb 2019

22.

Webster K, Cella D, Yost K (2003) The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation. Health Qual Life Outcomes 1(79):79. https://doi.org/10.1186/1477-7525-1-79 CrossRefPubMedPubMedCentral

23.

Shrout PE, Fleiss JL (1979) Intraclass correlations: uses in assessing rater reliability. Psychol Bull 86(2):420–428CrossRef

24.

Bharmal M, Fofana F, Barbosa CD, Williams P, Mahnke L, Marrel A, Schlichting M (2017) Psychometric properties of the FACT-M questionnaire in patients with Merkel cell carcinoma. Health Qual Life Outcomes 15(1):247. https://doi.org/10.1186/s12955-017-0815-5 CrossRefPubMedPubMedCentral

25.

Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45(2):228–247. https://doi.org/10.1016/j.ejca.2008.10.026 CrossRefPubMed

26.

Taber K (2017) The use of Cronbach’s alpha when developing and reporting research instruments in science education. Res Sci Educ 48:1273–1296. https://doi.org/10.1007/s11165-016-9602-2 CrossRef

27.

Cella D, Kallich J, McDermott A, Xu X (2004) The longitudinal relationship of hemoglobin, fatigue and quality of life in anemic cancer patients: results from five randomized clinical trials. Ann Oncol 15(6):979–986CrossRef

28.

Mallinson T, Cella D, Cashy J, Holzner B (2006) Giving meaning to measure: linking self-reported fatigue and function to performance of everyday activities. J Pain Symptom Manag 31(3):229–241. https://doi.org/10.1016/j.jpainsymman.2005.07.012 CrossRef

29.

Victorson D, Soni M, Cella D (2006) Metaanalysis of the correlation between radiographic tumor response and patient-reported outcomes. Cancer 106(3):494–504. https://doi.org/10.1002/cncr.21637 CrossRefPubMed

30.

Guy W (ed) (1976) ECDEU Assessment manual for psychopharmacology. US Department of Health, Education, and Welfare Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, Rockville

31.

Yost KJ, Eton DT (2005) Combining distribution- and anchor-based approaches to determine minimally important differences: the FACIT experience. Eval Health Prof 28(2):172–191. https://doi.org/10.1177/0163278705275340 CrossRefPubMed

32.

Cella D, Nichol MB, Eton D, Nelson JB, Mulani P (2009) Estimating clinically meaningful changes for the Functional Assessment of Cancer Therapy—Prostate: results from a clinical trial of patients with metastatic hormone-refractory prostate cancer. Value Health 12(1):124–129. https://doi.org/10.1111/j.1524-4733.2008.00409.x CrossRefPubMed

33.

Cella D, Eton DT, Fairclough DL, Bonomi P, Heyes AE, Silberman C, Wolf MK, Johnson DH (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(3):285–295CrossRef

34.

Cicchetti D (1994) Guidelines, criteria, and rules of thumb for evaluating normed and standardized assessment instruments in psychology. Psychol Assess 6(4):284–290CrossRef

Title: Validity and performance of the Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) among advanced urothelial cancer patients
Authors: Arnold Degboe
Cristina Ivanescu
Jeffrey M. Rohay
Ralph R. Turner
David Cella
Publication date: 01-11-2019
Publisher: Springer Berlin Heidelberg
Keywords: Urothelial Cancer
Urothelial Cancer
Cancer Therapy
Published in: Supportive Care in Cancer / Issue 11/2019
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-019-04709-0

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

At a glance: The STEP trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 11/2019

Comparison of perceptions of unmet supportive care needs between cancer patients and their oncologists

Extracorporeal shock wave therapy in the supportive care and rehabilitation of cancer patients

Psychosocial distress in oncology: using the distress thermometer for assessing risk classes

The effects of inpatient music therapy on self-reported symptoms at an academic cancer center: a preliminary report

Uroprotective effect of pantoprazole against cyclophosphamide-induced cystitis in mice

Predictors of the therapeutic effect of corticosteroids on radiation-induced optic neuropathy following nasopharyngeal carcinoma

Keynote webinar | Spotlight on antibody–drug conjugates in cancer