Patient Experience in Clinical Trials: Quality of Life, Financial Burden, and Perception of Care in Patients With Multiple Myeloma or Lymphoma Enrolled on Clinical Trials Compared With Standard Care

Abstract

QUESTION ASKED: Do patients with multiple myeloma or lymphoma treated on clinical trials have a different experience on the basis of patient-reported outcomes compared with patients treated outside of clinical trials? SUMMARY ANSWER: There was no difference in the experience of patients treated on clinical trials compared with patients treated outside of clinical trials, on the basis of patient-reported outcome measures (quality of life, quality of care, or financial burden) that were tracked from baseline to 1 year after treatment start. WHAT WE DID: We prospectively evaluated the experience of patients with multiple myeloma or lymphoma who were treated on clinical trials (clinical trial group, n 5 35) versus patients treated with standard approaches (nonclinical trial group, n 5 88) focusing on quality of life, financial burden of care, and patients' perception of quality of care over a 1-year period. WHAT WE FOUND: There were no significant differences in any of the patient-reported outcomes in patients treated on clinical trials versus those treated outside of clinical trials over the course of 1 year. There was an initial decline in overall quality of life in the first three months across both groups, driven primarily by decline in physical and functional well-being. Quality of life gradually improved in both groups and was above baseline by month 12. Patients reported highest improvement in the functional well-being subdomain. Patients in both groups reported high satisfaction with the quality of care received, and there were no differences in overall satisfaction, communication with the team, or access to care. At baseline, 16%-19% of patients reported financial burden, which increased to a peak of 33% in the clinical trial group and to 49% in the nontrial group over the course of 1 year. There was no significant difference in financial burden in the two groups overall. Most of the patients reported getting all the care that was deemed medically necessary in both groups. However, a significant proportion of patients reported having to make other kinds of financial sacrifices because of their cancer (clinical trial group: 33% of patients at baseline and 21%-40% over 1 year; nontrial group: 19% at baseline and 25%-36% over 1 year). BIAS, CONFOUNDING FACTORS, DRAWBACKS: Limitations of our study include a smaller cohort size of patients treated on clinical trials and a 50% drop-out rate at one year, which is common in questionnaire-based studies. This study was conducted at an academic center, and our results may not be generalizable to patients treated in community settings. REAL-LIFE IMPLICATIONS: Our findings can serve as a guide to educate patients regarding clinical trial participation and highlight the need to address the significant financial burden experienced by patients with cancer. abstract PURPOSE Patients' concerns regarding clinical trial (CT) participation include apprehension about side effects, quality of life (QoL), financial burden, and quality of care. METHODS We prospectively evaluated the experience of patients with multiple myeloma or lymphoma who were treated on CTs (CT group, n 5 35) versus patients treated with standard approaches (non-CT group, n 5 88) focusing on QoL, financial burden of care, and patients' perception of quality of care over a 1-year period. RESULTS There were no significant differences in any of the patient-reported outcomes in CT versus non-CT groups. We observed an initial decline in overall QoL in the first 3 months across both groups, driven primarily by physical and functional well-being. QoL gradually improved and was above baseline by month 12. Patients reported highest improvement in the functional well-being subdomain. Patients in both groups reported high satisfaction with the quality of care received, and there were no differences in overall satisfaction, communication with team, or access to care. At baseline, 16%-19% of patients reported financial burden, which increased to a peak of 33% in the CT group and to 49% in the non-CT group over the course of 1 year. There was no significant difference in financial burden in the two groups overall. Most of the patients reported getting all the care that was deemed medically necessary in both groups. However, a significant proportion of patients reported having to make other kinds of financial sacrifices because of their cancer (CT group: 33% of patients at baseline and 21%-40% over 1 year; non-CT group: 19% at baseline and 25%-36% over 1 year). CONCLUSION Patients treated on CTs reported comparable QoL and quality of care with the non-CT group. A high proportion of patients reported financial burden over time in both groups. Our findings can serve as a guide to educate patients regarding CT participation and highlight the need to address the significant financial burden experienced by patients with cancer.