Study Supports Use of EORTC Item Library to Assess Lymphoma Symptoms

Qualitative and quantitative evidence supporting the use of the European Organization for Research and Treatment of Cancer (EORTC) Item Library revealed little concern among patients and clinicians with using these items to assess symptoms of conditions such as chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL), according to a recent study published in Journal of Patient-Reported Outcomes.

This analysis included primary qualitative research and secondary exploratory research | Image credit: everythingpossible - stock.adobe.com

Patient-reported outcomes (PROs) can be useful when evaluating new therapies for B-cell malignancies, which are often difficult to treat. However, evaluating benefits in clinical trials with PRO measures requires careful consideration, and little research has been conducted to determine which PRO measures should be used when determining symptoms and if they are useful at all.

The investigators sought to determine which PRO concepts are most important to patients with CLL/SLL or MCL—especially in relation to their symptoms. Additionally, they analyzed if the selection of items from the EORTC Item Library, which offers a possible pathway to constructing symptom impact assessments in cancer, can form a sensible basis for creating a blueprint of disease-related symptoms from these diseases.

The study used mixed methods, comprising a primary qualitative research strand and a secondary exploratory quantitative research strand, the investigators wrote. The qualitative research centered around a literature review, clinician interviews, and patient interviews.

A literature review of qualitative research indicated key symptom concepts, including fatigue, dyspnea, pain, and swelling. Key impact concepts included the functional impacts of walking and doing household chores, and the emotional and social impacts of depression, worry, and social life limitations, the investigators found.

Participating clinicians confirmed the symptoms in each disease area that were identified in the literature review. Additionally, they highlighted symptoms such as lymphadenopathy, those associated with anemia, and systemic symptoms including fever, night sweats, and weight loss.

Moving on to patient interviews, the investigators wrote that 41 participants were enrolled and interviewed in their study (20 participants with CLL/SLL, and 21 with MCL). The participants reported a variety of symptoms and disease-related impacts, and there was a large degree of overlap.

The investigators grouped reported symptoms under 10 domains: swollen lymph nodes, B symptoms, abdominal issues, fatigue, pain, subjective cognitive impairment, other anemia-related issues, thrombocytopenia-related bleeding issues, infection, and other issues. Impact concepts were grouped into 3 domains: physical function, role function, and other impacts such as psychological impact, according to the investigators.

Fatigue was highlighted through patient interviews as one of the most important symptoms, both at diagnosis and over the course of the disease, the investigators found. Fatigue’s persistence and pervasiveness, as well as its impact on everyday life, were emphasized strongly by the patients.

Furthermore, patients described their experiences dealing with B symptoms, which were described across both CLL/SLL and MCL. They described experiencing these symptoms successively, separately, or in combination, the investigators found.

A quantitative analysis was also conducted. The results showed satisfaction with the distribution of the item responses to the full EORTC questionnaire provided to the participants to gauge symptoms across the conditions, and that the items were “very much” relevant to CLL/SLL and MCL.

Overall, the participants indicated that the items presented were able to accurately describe the range of symptom severity experienced, the investigators found. Furthermore, the items were deemed to be sufficiently targeted to the study participants.

“The flexibility of adding additional targeted items to capture aspects of disease and treatment not previously considered allows researchers to collect a more nuanced assessment of patient experience,” the investigators wrote.

Some limitations of the study were acknowledged by the study authors. The study relied on patient-reported diagnoses, and the study population was mostly non-Hispanic and White, which limits the generalizability of the findings.

The investigators concluded by discussing the preliminary nature of the findings and determined that the PRO measures resulting from this research should undergo further evaluation in larger cohorts to better understand the benefits for the affected populations.

Reference

Markowitz JT, Mazerolle F, Lovell T, et al. Mixed-methods research to support the use of new lymphoma-specific patient-reported symptom measures derived from the EORTC item library. J Patient Rep Outcomes. 2024;8(1):8. doi:10.1186/s41687-024-00683-2