A tool used to identify primary concerns of patients was helpful in identifying main worries about time, as it related to quality of life (QOL), and held value for patients and clinicians.
Although a patient reported outcome quality of life tool (PROQOL) did not bring about a QOL difference compared with usual care, it was effective in identifying primary concerns of patients with multiple myeloma (MM), light chain amyloidosis, head and neck cancer, and gynecologic malignancies over time and was a worthwhile tool for clinicians, according to study findings published in Contemporary Clinical Trials Communications.
PROs have been pushed for inclusion in clinical research by the FDA, as they can clarify physical or functional impairment and psychological and social effects. Using PRO surveys can help clinicians assess symptoms and give an overall better quality of care. This study aimed to determine whether the PROQOL tool could improve QOL more than usual care at the end of a 12-month follow-up.
The single center nonblinded prospective clinical trial included participants who were 18 years and older; had MM, light chain amyloidosis, head and neck cancer, or gynecologic malignancies; had continued cancer care at Mayo Clinic in Rochester, Minnesota; and were able to use an iPad.
All participants were offered the PROQOL prior to every visit, and the patients would select 1 of 8 categories to focus on: personal relationship, emotional health, physical health, cancer diagnosis and treatment, health behaviors, money, care planning, or something else. Usual care was defined as patients explaining their symptoms or concerns and clinicians addressing those concerns.
There were 233 patients who were enrolled in the hematologic cohort of the study from July 2016 to April 2018, with 60.1% of participants male and a median age of 62 (range, 31-87) years. The solid tumor cohort had 150 patients enrolled between September 2016 and August 2017, where 78.7% were female and the median age was 63 (range, 32-84) years. There were patients in both cohorts who died during the study (11% in the hematologic cohort, 23% in the solid tumor cohort).
The most common overall primary concern was physical health (30.9%), followed by cancer diagnosis and treatment (29.1%). Both selections remained the most popular when patients were allowed to select a second option.
The study found that concerns varied more as patients had more visits. The mean (SD) number of unique concerns increased from 1.9 (0.6) with 1 to 3 visits to 2.7 (0.8) with 4 to 5 visits to 3.9 (1.3) with 6 or more visits.
The most popular sub-concerns that were selected in physical health were fatigue (47.8%), neuropathy (43.4%), and difficulty sleeping (29.9%). The most selected sub-concerns in the cancer diagnosis category were treatment plans (60.5%), prognosis (49.7%), and chemotherapy (28.4%).
Money and physical health were more likely to be selected by the hematologic cohort compared with the solid tumor cohort, at 9.9% vs 5.2% and 45.3% vs 38.0%, respectively. The solid tumor cohort picked health behaviors more often (23.5% vs 13.2%). In addition, women selected healthy behaviors more often (21.3% vs. 12.1%) vs men whereas men were more likely to select physical health (48.0% vs 38.2%).
Patients younger than 65 years demonstrated more concern for money vs older participants (12% vs 5%) whereas care planning was more important in patients 65 years and older (9.1% vs 4.4%).
The researchers found no significant difference in QOL between patients using the PROQOL and usual care at the end of the 12-month period for either the combined cohort or the individual cohorts. However, 94% of clinicians surveyed were satisfied with the PROQOL and saw an improvement in their patients’ well-being.
There were some limitations to this study. The main concerns between clinic visits could not be assessed, and summaries of main concerns and actionable list of resources generated by the PROQOL were not recorded in the electronic health record, which limited integration of PROs in clinical practice.
“The PROQOL tool held considerable value in aiding patients in identifying patients’ main concerns over time and was a worthwhile experience for both patients and clinicians,” the authors concluded.
Warsame R, Cook J, Fruth B, et al. A prospective, randomized trial of patient-reported outcome measures to drive management decisions in hematology and oncology. Contemp Clin Trials Commun. Published online July 13, 2022. doi:10.1016/j.conctc.2022.100964