A prospective, randomized trial of patient-reported outcome measures to drive management decisions in hematology and oncology.
AL, Light chain amyloidosis
GYN, Gynecologic malignancies
H/N, Head and Neck malignancy
Health care delivery
MM, Multiple myeloma
Patient-reported outcomes
Quality of life
Journal
Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157
Informations de publication
Date de publication:
Oct 2022
Oct 2022
Historique:
received:
18
08
2021
revised:
30
06
2022
accepted:
08
07
2022
entrez:
5
8
2022
pubmed:
6
8
2022
medline:
6
8
2022
Statut:
epublish
Résumé
Clinicians have limited time during patient encounters which can result in patients' concerns not being addressed. This study's objective was to test whether an electronic patient-reported outcome quality of life tool (PROQOL) in which patients identify their primary concern during clinic visits improves cancer patient quality of life (QOL). This single center non-blinded prospective clinical trial randomized patients (2:1) to PROQOL versus usual care (UC). Two patient cohorts were enrolled: those with hematologic malignancies (multiple myeloma [MM] or light chain amyloidosis [AL]) and solid tumors (head and neck [H/N] or gynecologic [GYN] malignancies). Primary endpoint was patient-reported QOL at 12 months measured by a single-item Linear Analog Self-Assessment. Value to patients and impact on clinician workflow was measured using a "was it worth it" survey. The study was powered to detect a 0.5 standard deviation difference between groups. Overall 383 patients were enrolled, 171 with MM, 62 AL, 113 GYN, and 37 H/N between July 2016 and April 2018, with 12-month follow-up. There were 171 (44.6%) male patients and median age was 62 years (range 31-87). The most often selected concern was physical health (30.9%), and second was cancer diagnosis and treatment (29.1%). Mean QOL was 7.12 for PROQOL and 6.98 for UC (0-10 scale) at 12 months, with no between-group difference overall (p = 0.56) or within hematologic or solid tumor cohorts, respectively. Among patients, 74% thought the PROQOL tool was worthwhile, 86% would choose PROQOL again, and 81% would recommend it to others. Among clinicians, 95% responded that PROQOL was worthwhile and did not think that PROQOL negatively impacted their workflow. Although we did not demonstrate a QOL difference between PROQOL and UC groups; the PROQOL tool held considerable value in identifying patients' main concerns over time and was worthwhile for patients and clinicians.
Sections du résumé
Background
UNASSIGNED
Clinicians have limited time during patient encounters which can result in patients' concerns not being addressed. This study's objective was to test whether an electronic patient-reported outcome quality of life tool (PROQOL) in which patients identify their primary concern during clinic visits improves cancer patient quality of life (QOL).
Patients and methods
UNASSIGNED
This single center non-blinded prospective clinical trial randomized patients (2:1) to PROQOL versus usual care (UC). Two patient cohorts were enrolled: those with hematologic malignancies (multiple myeloma [MM] or light chain amyloidosis [AL]) and solid tumors (head and neck [H/N] or gynecologic [GYN] malignancies). Primary endpoint was patient-reported QOL at 12 months measured by a single-item Linear Analog Self-Assessment. Value to patients and impact on clinician workflow was measured using a "was it worth it" survey. The study was powered to detect a 0.5 standard deviation difference between groups.
Results
UNASSIGNED
Overall 383 patients were enrolled, 171 with MM, 62 AL, 113 GYN, and 37 H/N between July 2016 and April 2018, with 12-month follow-up. There were 171 (44.6%) male patients and median age was 62 years (range 31-87). The most often selected concern was physical health (30.9%), and second was cancer diagnosis and treatment (29.1%). Mean QOL was 7.12 for PROQOL and 6.98 for UC (0-10 scale) at 12 months, with no between-group difference overall (p = 0.56) or within hematologic or solid tumor cohorts, respectively. Among patients, 74% thought the PROQOL tool was worthwhile, 86% would choose PROQOL again, and 81% would recommend it to others. Among clinicians, 95% responded that PROQOL was worthwhile and did not think that PROQOL negatively impacted their workflow.
Conclusions
UNASSIGNED
Although we did not demonstrate a QOL difference between PROQOL and UC groups; the PROQOL tool held considerable value in identifying patients' main concerns over time and was worthwhile for patients and clinicians.
Identifiants
pubmed: 35928285
doi: 10.1016/j.conctc.2022.100964
pii: S2451-8654(22)00081-3
pmc: PMC9344350
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100964Subventions
Organisme : NCI NIH HHS
ID : P30 CA015083
Pays : United States
Organisme : NCI NIH HHS
ID : P50 CA186781
Pays : United States
Informations de copyright
© 2022 The Authors.
Déclaration de conflit d'intérêts
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Références
J Multidiscip Healthc. 2018 Jan 19;11:49-61
pubmed: 29403284
Health Aff (Millwood). 2013 Jun;32(6):1143-52
pubmed: 23676531
JAMA. 2022 Jun 28;327(24):2413-2422
pubmed: 35661856
Ann Oncol. 2018 Aug 1;29(8):1718-1726
pubmed: 30010772
Support Care Cancer. 2016 Jul;24(7):3047-56
pubmed: 26887586
Gynecol Oncol. 2010 Nov;119(2):390-6
pubmed: 20594586
J Clin Oncol. 2008 Mar 10;26(8):1338-45
pubmed: 18323558
Patient Relat Outcome Meas. 2018 Jul 27;9:245-252
pubmed: 30100773
CMAJ. 2017 Nov 13;189(45):E1405-E1406
pubmed: 29133547
BMJ Open. 2019 Apr 20;9(4):e024454
pubmed: 31005911
Patient Relat Outcome Meas. 2018 Nov 01;9:353-367
pubmed: 30464666
J Clin Oncol. 2012 Dec 1;30(34):4249-55
pubmed: 23071244
Health Qual Life Outcomes. 2012 Jan 31;10:14
pubmed: 22289425
Am Soc Clin Oncol Educ Book. 2016;35:200-8
pubmed: 27249700
Am Soc Clin Oncol Educ Book. 2017;37:695-704
pubmed: 28561689
Lancet Oncol. 2019 Dec;20(12):e685-e698
pubmed: 31797795
JAMIA Open. 2018 Jul;1(1):49-56
pubmed: 31093606
J Adolesc Young Adult Oncol. 2020 Feb;9(1):105-110
pubmed: 31524556
Am J Prev Med. 2011 May;40(5 Suppl 2):S198-207
pubmed: 21521595
J Clin Oncol. 2017 Nov 1;35(31):3618-3632
pubmed: 28892432
Perspect Clin Res. 2011 Oct;2(4):137-44
pubmed: 22145124
Clin Oncol (R Coll Radiol). 2016 Mar;28(3):209-14
pubmed: 26698027
Health Qual Life Outcomes. 2003 Oct 23;1:60
pubmed: 14613562
JAMA Oncol. 2019 May 01;5(5):644-652
pubmed: 30946436
Ann Oncol. 2019 Feb 1;30(2):167-169
pubmed: 30481270
J Clin Oncol. 2016 Feb 20;34(6):557-65
pubmed: 26644527
BMC Health Serv Res. 2013 Jun 11;13:211
pubmed: 23758898
Health Expect. 2017 Oct;20(5):1073-1080
pubmed: 28261901
Support Care Cancer. 2011 Apr;19(4):475-81
pubmed: 20401497
J Clin Oncol. 2020 Feb 1;38(4):292-301
pubmed: 31804869
Am Soc Clin Oncol Educ Book. 2018 May 23;38:122-134
pubmed: 30231381
BMC Cancer. 2012 Feb 28;12:77
pubmed: 22373218
Blood Cancer J. 2016 Oct 21;6(10):e485
pubmed: 27768093
Value Health. 2011 Dec;14(8):1101-8
pubmed: 22152180
J Clin Oncol. 2014 May 10;32(14):1480-501
pubmed: 24711559
Gynecol Oncol. 2018 Jan;148(1):12-18
pubmed: 29174565
Br J Gen Pract. 2013 Oct;63(615):e657-68
pubmed: 24152480
Cancer. 2012 Dec 1;118(23):5964-72
pubmed: 23007632
Cancer. 2017 Mar 1;123(5):869-878
pubmed: 27859009
Am Health Drug Benefits. 2015 Jun;8(4):204-15
pubmed: 26157542
J Gen Intern Med. 2012 Apr;27(4):445-51
pubmed: 22038469
Am Soc Clin Oncol Educ Book. 2018 May 23;38:662-666
pubmed: 30231405