A prospective, randomized trial of patient-reported outcome measures to drive management decisions in hematology and oncology

Rahma Warsame; Joselle Cook; Briant Fruth; Joleen Hubbard; Katrina Croghan; Katharine A R Price; Aminah Jatoi; Shaji Kumar; Carrie Thompson; Jan Buckner; Angela Dispenzieri; Jeff Sloan; Amylou C Dueck

doi:10.1016/j.conctc.2022.100964

A prospective, randomized trial of patient-reported outcome measures to drive management decisions in hematology and oncology

Contemp Clin Trials Commun. 2022 Jul 13:29:100964. doi: 10.1016/j.conctc.2022.100964. eCollection 2022 Oct.

Authors

Rahma Warsame^{1

2}, Joselle Cook^{1

3}, Briant Fruth⁴, Joleen Hubbard³, Katrina Croghan¹, Katharine A R Price³, Aminah Jatoi³, Shaji Kumar¹, Carrie Thompson¹, Jan Buckner³, Angela Dispenzieri¹, Jeff Sloan⁴, Amylou C Dueck⁵

Affiliations

¹ Division of Hematology, Mayo Clinic, Rochester, MN, USA.
² Patricia and Robert Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.
³ Department of Medical Oncology, Mayo Clinic, Rochester, MN, USA.
⁴ Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA.
⁵ Department of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA.

Abstract

Background: 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: 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: 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: 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.

Keywords: 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.

Abstract

Grants and funding