Participant Demographics and Characteristics
The focus group session was held in Houston, Texas, and consisted of five women and one man as participants, with a mean age of 35.3 (range 26–48) years. The average time since their primary diagnosis of EBV+ PTLD was 11.8 year (range of 8 months to 20 years). The average time from resolution of their EBV+ PTLD was 11.3 years (range 2 months to 19 years).
Three major themes emerged from the analysis of the PRO domains: physical functioning, emotional functioning, and social functioning. Table 2 summarizes some key messages for each of the major themes.
All participants felt that EBV+ PTLD significantly affected their physical functioning, especially at the direct location of their PTLD. General physical abilities, such as walking or daily self-care routines, were not affected to the same degree unless the location of the PTLD interfered with that activity.
Most participants reported that they suffered from severe acute pain in the direct location of their PTLD, which in turn affected their HRQoL. Additionally, most patients reported significant physical fatigue to be the most limiting factor of their activities of daily living (ADLs; e.g., bathing, getting ready for the day). The participants also had a reduced overall desire to partake in daily activities, especially those for fun (i.e., they experienced anhedonia).
All participants experienced and were significantly impacted by work productivity loss as they missed times from school or work due to symptoms or treatment of EBV+ PTLD.
Participants also described significant fatigue and fatigue-related pain (see Table 2). For some of the participants, the pain and fatigue were so severe that it resulted in hospitalization, severely limited their ability to make decisions, and significantly impacted their ADLs, such as eating and sleeping.
Many participants indicated that EBV+ PTLD affected emotional functioning (Table 2), especially their emotional and mental fatigue. Participants reported experiencing a lack of self-confidence and motivation. Some felt “dissociated” or “isolated,” “numb to everything,” “down in the dumps,” “deep despair,” and “extreme emotions.” A few participants indicated that immunosuppression led to emotional distress since it created an omnipresent fear of contracting a new illness, including the possibility of contracting another PTLD. One participant even described feeling numb and disassociated from the possibility of such reality.
Participants also expressed feeling conflicted when it came to reality, or the perception of reality. They described how everyone around them assumed that they should be happy given their transplant, but internally they often felt sad. This duality resulted in a decreased desire to spend time with their friends and family, further contributing to their feelings of isolation. Indeed, some participants stated that their sense of isolationism became exacerbated post-transplant because their follow-up treatment locations were far away from their home, where it was more difficult for their family and friends to visit.
Some of the patients also noted a special case of pervasive anxiety. Specifically, these participants talked about pervasive anxiety, even after PTLD resolution, stating that there is always a fear that the cancer could return and that it is “in the back of your mind that you are a cancer survivor.” This specific aspect of pervasive anxiety goes beyond the specific content of what is included in any of the examined PROs but is a more extreme extrapolation of content within emotional functioning.
All patients agreed there were social challenges associated with EBV+ PTLD. A highly endorsed perception was that of living in “two worlds” as patients reported behaving differently with friends/family compared to when they were alone (Table 2). Despite having family and caregivers for primary social support, participants still voiced their feelings of isolation. Interestingly, participants felt supported from care group websites and online chat forums where they were able to participate at their leisure; the hope of getting responses back made them feel connected. Online social pages were important outlets as participants felt they were able to engage on a regular basis. This is likely because other outlets, such as more physically strenuous leisure or recreational social activities (i.e., sports), were unavailable due to the participants’ physical fatigue.
Concept Elicitation Findings
There were additional findings in the concept elicitation portion that expanded on the domains reviewed during concept confirmation. A few items were endorsed by either one or two participants. One participant suffered anxiety on the visual cues associated with PTLD (if present, depending on the location of PTLD). Another participant expressed concerned with the management of life after PTLD, which included various medications.
Relevance of PROs Instruments
The findings from the focus group provide important insights on the HRQoL among patients with EBV+ PTLD. During the focus group session, topics of discussion were based on the PROs of interest (i.e., EQ-5D, SF-36v2, and FACT-LYM). The relevance of these concepts or domains for this population was elucidated from participant responses. Results from this analysis are shown in Table 3 together with the degree of relevance of the domains (i.e., no relevance, some relevance, and high relevance). None of the instruments provided a fully comprehensive measure of the concerns of EBV+ PTLD measures, but all instruments had a number of relevant aspects. The FACT-LYM, a tool developed for lymphoma patients, had the greatest relevance for its content domains among patients with EBV+ PTLD as all of its domains had some relevance.
Participants indicated that PTLD did not affect their physical mobility in general (only if their PTLD was in a specific location); consequently, the first three domains of the EQ-5D (i.e., mobility, usual care, and self-care) were assessed as not relevant (Table 3). Alternatively, most participants professed that they experienced pain and indicated that the pain/discomfort domain of the EQ-5D was very relevant, especially at the PTLD site. Lastly, the anxiety/depression domain was considered to be highly relevant by participants as they reported experiencing anxiety and depression during the treatment phase.
Participants in the focus group found that most domains of the SF-36v2 were relevant for the signs and symptoms of the disease (Table 3). The domains of physical functioning and physical role limitations of the SF-36v2 were considered relevant to patients with EBV+ PTLD as the items in these domains query a lack of energy and fatigue. Overall, the items in the general health perception domain of the SF-36v2 are related to health status. Participants indicated that a “healthy” scale (i.e., items in domain general health perceptions) was not appropriate for someone with EBV+ PTLD. Participants reported that their social life was greatly impacted by EBV+ PTLD and, therefore, they also felt an inability to lead a normal social life. Thus, the social functioning domain of SF-36v2 was considered by this patient population to be very relevant. The emotional and mental health domains were also considered to be quite relevant as participants expressed that they were significantly impacted as they faced extreme emotions, loneliness, fear, and anxiety of developing new symptoms.
The FACT-LYM was developed to assess HRQoL in patients with non-Hodgkin’s lymphoma; consequently, the lymphoma-specific questions under “additional concerns” surrounding treatment side effects, lymphoma symptoms, and emotional responses to such symptoms were considered to be particularly applicable to this population. All domains of the FACT-LYM were rated as highly relevant, with the exception of the functional well-being domain that was rated as having some relevance. Participants cited productivity and work loss as well as an inability to fully enjoy life but did not cite any specifically sleep-related problems due to their disease.