Description of study participants. A total of 174 patient visits to a complex surgical oncology ambulatory clinic between May 27 and July 29, 2020 were included in the study (Table 1). The median patient age was 62 (range 19-90) and 53% were female. The primary tumor site was gastrointestinal in 31%, soft tissue in 48%, and “other” in 21%. Recruitment into the three cohorts (Virtual, Hard-copy, Virtual-mentored) was sequential based on clinic date, with cohort size adapted to the observed ESAS completion rate as the study proceeded (see Methods). Age, sex and tumor site did not differ between the three cohorts (Table 1). We further characterized patients according to the phase of their cancer journey at the time of the study: 41% of patient visits were within a phase of Active investigation or treatment, 50% were in Surveillance following treatment, and 9% were while receiving symptom-directed care for cancer that was not considered curable (Palliative). There was a significant difference in the distribution of management phase between the cohorts. Patients in the Hard-copy cohort were more likely to be undergoing Active investigation/treatment (54%) or receiving Palliative measures (20%) and less likely to be in Surveillance (26%) than those in either the Virtual or Virtual-mentored cohorts (p<0.05, c2).
ESAS completion rates. Of the 174 ambulatory visits, 127 culminated in ESAS completion by the patient; three patients formally declined to complete the ESAS form (Fig. 1). At the start of the study, a research team member contacted the patient by phone shortly after their virtual or in-person visit with the physician. The ESAS form was then emailed to an address provided by the patient. For the first cohort (Virtual), 46 patients were approached over a three-week interval, 15 of whom did not respond after up to 3 phone calls and 3 emails. One patient declined to complete the form (Supplemental Table 1). The ESAS form was emailed to the remaining 30 patients, together with instructions to complete and return the form electronically. While 20 patients did complete the survey, 4 of these requested to complete it via phone transcription with a member of the research team, as they stated that they had difficulty handling the PDF. The overall completion rate for this Virtual cohort, analyzed by “intention to treat”, was 44%, and ~60% of the non-completions reflected upfront lack of response from the patient. Postulating that the low completion rate might be related to the virtual format and remote relationship between study participant and the research team, we reverted to the hard-copy format initially employed when ESAS forms were first rolled out at our institution in 2007. Over the next 3 weeks, 50 patients who visited the clinic in person were asked to complete a printed ESAS form (Hard-copy cohort). 49 (98%) agreed and did so; one patient agreed to complete the form, but deferred to the end of the appointment and did not return it.
Given the notable discrepancy in completion rate between the two initial cohorts, we speculated that significant barriers to patient handling of the virtual ESAS form might have existed. Using an adaptive approach, we created an intervention cohort, offering patients “virtual mentoring” to assist with the practical aspects of questionnaire completion and return. For this final Virtual-mentored cohort, 78 patients who attended clinic in-person or virtually were approached over a 4-week interval. 2 formally declined to complete the form, and 18 of the 76 who had originally agreed to complete the form did not ultimately return a completed ESAS, 2 returning a blank form, and 16 not returning a form despite verbal offer of mentorship. Of the 58 patients (74%) who successfully completed the form, two requested to do so via phone transcription, dictating their responses to the research team member, and ten requested to complete a hard-copy form in clinic (Fig.1).
We queried patient- and disease-related variables that might be associated with ESAS completion. Analysis of all patients in the three cohorts grouped together showed that completion was not predicted by age, sex or primary tumor site (Table 2). Patients who did not complete were less likely to be under active investigation/treatment than those who did (28% vs. 46%, p=0.04, c2). Analysis of the subgroup of patients included in the Virtual and Virtual-mentored cohorts (n=124) also showed that questionnaire completion was not predicted by age, sex, or primary tumor site, nor was it predicted by management phase (Table 3).
ESAS patient reported data. Of the 127 ESAS forms completed by patients in all three cohorts, 117 (92%) reported at least one symptom score ≥1, indicating the presence of a symptom. The overall responses for each symptom scale are shown in Fig. 2A, categorized by symptom severity. The symptom with the highest prevalence of clinically significant severity was depression (42% had a score ≥2), followed by wellbeing (35% ≥4), tiredness (31% ≥4) and anxiety (27% ≥4). The ESAS total symptom burden score (>30: moderate-to-severe vs. £30: absent-to-mild), as another measure of clinically significant distress, showed that 20% of respondents (26/127) had a moderate-to-severe total symptom burden (Suppl Table 2).
There was no difference in the ESAS total symptom burden score reported between the three cohorts (>30 in 20%, 22%, 38% of Virtual, Hard-copy and Virtual-mentored cohort respondents, respectively). Similarly, there were no significant differences in individual symptom scores reported for each cohort, as illustrated by the distribution of scores for depression, wellbeing, tiredness and anxiety (Fig. 2B-E) and the remaining individual symptoms (Supplemental Figure). High total symptom burden was not predicted by age, sex or management phase, although patients with high total symptom burden were more likely to have a primary GI tumor (50% vs. 28% of those with low symptom burden, p=0.02, c2) (Suppl Table 2).
In nine patients (2 Virtual; 1 Hard-copy; 6 Virtual-mentored), review of symptom severity scores by a member of the research team prompted follow-up conversations to validate and clarify the reported symptoms. Six patients were having significant, poorly controlled physical symptoms, and with patient consent this was directly communicated to the most responsible physician by a member of the research team. Three patients who had high anxiety and depression scores were questioned further: one had an established relationship with a psychiatrist, and two were offered referral to psychosocial support services at the cancer center. In particular, review of the ESAS forms triggered an intervention in 4 of 6 Virtual-mentored patients with high scores.
Barriers to virtual completion of patient reported outcome questionnaire. Of 106 visits that yielded an agreement by the patient to virtually complete and return an ESAS form, 28 did not culminate in completion (10/30 and 18/76 in the Virtual and Virtual-mentored cohorts, respectively). Some patients in the Virtual cohort stated that they were unable to open, complete or save the PDF, and others reported generalized “technology-phobia”. Of the subgroup of patients in the Virtual-mentored cohort who completed the form, the majority felt it was a straightforward process, and had no difficulty. The few individuals who had challenges with handling the PDF were able to overcome them with the help of a research team mentor.