Qualitative Assessment Of Symptoms and Functional Impact In Relapsed/Refractory Multiple Myeloma Patients and Comparison To The EORTC QLQ-C30 and My-20, FACT-MM, and MDASI-MM
Authors: Trask Peter C , Taylor Fiona , Shields Alan , Gallagher Meghan , Mehta Jyotsna , Foley Catherine , Olude Funke , Lamoureux Roger , Iovin Ramon , Hsu Karl 
Published: October 2019

Abstract

Background
Multiple myeloma (MM) is the second most common hematological malignancy in the U.S., and is characterized by bone pain, appetite loss, fatigue, and treatment-related symptoms. These symptoms can have potentially devastating effects on patients' health-related quality of life (HRQoL). While several instruments are available to evaluate the symptomatic profile and HRQoL of MM patients, it is unclear whether their conceptual coverages are adequate in the relapsed or refractory (R/R) setting. In order to address this concern, we conducted a qualitative study in R/R MM patients and compared the results to the conceptual frameworks of three instruments available for use in this population.

Methods
Qualitative concept elicitation (CE) interviews were conducted with MM patients in the U.S. Patients were considered eligible for participation if they were at least 18 years of age, fluent in U.S. English, currently receiving treatment for MM considered to be R/R, and had an ECOG Performance Status of 0-2. Patients who were receiving first-line therapy for their cancer; were mentally or legally incapable of consenting to the study; or had a concurrent diagnosis or condition that would interfere with their ability to participate in the study were excluded. Interviews were conducted according to a semi-structured interview guide. Questions were open-ended and focused primarily on patients' disease- and treatment-related symptoms and how those symptoms impacted their lives. Targeted follow-up questions were used to elicit additional information when appropriate. Interviews lasted approximately 60 minutes and were audio recorded; all interview recordings were transcribed and de-identified. Qualitative data were analyzed using a grounded theory approach that combined semi-quantitative and qualitative methods. The concepts reported by patients were evaluated for saturation and subsequently compared with the conceptual frameworks of the EORTC QLQ-C30 and QLQ-MY20, FACT-MM, and MDASI-MM instruments.

Results
A total of 15 MM patients (age range = 56 to 89 years; mean age = 68.8±10.4 years) participated in the CE interviews and were included in analysis. Most patients were white (n=13, 86.7%), and about half were male (n=8, 53.3%). Two-thirds of the sample had some form of college education (i.e., certificate, two- to four-year college degree, or graduate degree). Most were married (n=11, 73.3%), and all but one reported living with family or friends (n=14, 93.93%). Patients were most commonly retired (n=8, 53.3%). Time since diagnosis ranged from 1 to 7 years, with a mean of 3.2±2.0 years. Just over half of the participants (n=8, 53.3%) had stage 3 MM at diagnosis. Eight patients (53.3%) were on second line treatment, six patients (40.0%) on third line treatment, and one patient (6.7%) on seventh line treatment. A total of 27 disease-related symptom concepts were reported by MM patients. Of those, the most commonly reported were tiredness (n=8, 53.5%), back pain (n=4, 26.7%), lack of energy (n=3, 20.0%), pain (location not specified) (n=3, 20.0%), shortness of breath (n=3, 20.0%), and weakness (n=3, 20.0%). The remaining 21 symptom concepts were reported by ≤2 patients each (≤13.3%). A total of 43 disease-related HRQoL impacts were reported by MM patients during CE interviews. The most commonly reported were work (n=6, 40.0%), thinking about cancer (n=5, 33.3%), exercise (n=4, 26.7%), social activities (n=4, 26.7%), household activities (n=4, 26.7%), and financial (n=4, 26.7%). Saturation was reached for 22 MM symptoms and 35 HRQoL impacts, and was questionable for 4 symptoms and 11 impacts. Overall, of the 10 disease-related symptom concepts reported by >1 MM patient, 7 (70.0%) were covered by the QLQ-C30 and MY-20, 5 (50.0%) by the FACT-MM, and 6 (60.0%) by the MDASI-MM. Of the 28 disease-related impacts reported by >1 MM patient, 15 (53.6%) were covered by the QLQ-C30 and MY-20, 11 (39.3%) by the FACT-MM, and 9 (32.1%) by the MDASI-MM.

Conclusions
These findings indicate that the majority of symptoms reported by R/R MM patients are captured by the existing EORTC QLQ-C30 and QLQ-MY20 instruments. A non-trivial gap in conceptual coverage is evident, however, which suggests that there remains room for improvement in assessing the experience of this patient population. Additional patient recruitment is ongoing to ensure saturation, and to further evaluate the need for a fit-for-purpose measure.

Disclosures:
Trask: Sanofi: Employment. Taylor:Adelphi Values: Employment. Shields:Adelphi Values: Employment. Gallagher:Sanofi: Employment. Mehta:Sanofi: Employment. Foley:Adelphi Values: Employment. Olude:Adelphi Values: Employment. Lamoureux:Adelphi Values: Employment. Iovin:Adelphi Values: Employment. Hsu:Sanofi: Employment.