In an effort to better understand the effects of chronic lymphocytic leukemia (CLL) from the patient perspective, researchers aimed to create a conceptual model of disease- and treatment-related signs, symptoms, and impacts in patients with first-line or relapsed/refractory CLL. The conceptual model was based on literature searches, review of CLL patient blogs/forums, interviews with expert hematologists, and semi-structured concept elicitation interviews of 40 patients with CLL, 20 of whom were receiving first-line treatment and 20 of whom had relapsed or were refractory to their prior treatment. Inclusion criteria included fatigue, weight loss, fever, and/or night sweats in the previous week.
To create different versions of the model, researchers mapped the number of patients citing each concept, and the concept’s mean disturbance rating on a scale of 0 to 10, where 0 = not at all and 10 = very. Literature searches identified 32 prevalent concepts, with the most common being fatigue/tiredness. Patient blogs/forums revealed additional symptoms, such as muscle/joint aches, headaches, and weakness, as well as impacts, which included stress, fear of death, and uncertainty. Clinicians reported recurrent infections and swollen lymph nodes as key signs of CLL and noted that fatigue is related to both symptoms and effects.
A total of 50 concepts were revealed during the concept elicitation interviews with patients, 42 of which were present in both first-line and relapsed/refractory patients. Of these, fatigue arose as the most prominent and debilitating. A number of fatigue-related subconcepts were identified, covering symptoms (tiredness/need to sleep, lack of energy, weakness, cognitive fatigue) and disease-related impacts (decreased ability to maintain social/familial/professional role, decreased physical functioning, frustration).
Three versions of the conceptual model were created: an overall model with all identified concepts, and 2 models highlighting the most salient concepts (Table).
The 3 versions of the conceptual model can help to inform patient-centered end points to evaluate new treatments for treatment-naïve or relapsed/refractory patients.
Abstract e19001; Chung H, et al.