Emergency department visits and hospitalizations (EDH) are common during chemotherapy (CH). EDH may be preventable with adequate support between CH visits but large-scale evaluations of virtual supportive care are limited.
We undertook a pragmatic, cluster-randomized trial to examine the effectiveness of pro-active telephone management of toxicities in early stage breast cancer (BC) patients receiving CH at 20 cancer centres in Ontario, Canada. Centres were allocated using a covariate-constrained approach to standardized, nurse-led calls to assess common toxicities at 2 time points following each cycle (intervention), or routine care (control). Participants were all patients with stage I-III BC commencing adjuvant or neo-adjuvant CH at participating centres during the centre recruitment period. A subset of 25 patients from each centre completed patient-reported outcome questionnaires. Cluster-level mean number of EDH visits/patient during the entire CH course, was evaluated using healthcare administrative data. Secondary outcomes included toxicity (NCI PRO CTCAE), self-efficacy (Stanford) and quality of life (QoL; FACTB). Penetration was the percentage of patients who received the intervention at the 10 intervention sites.
Baseline characteristics of participants, enrolled from 02/16-11/17, were similar in the intervention (n=944) and control groups (n=1214); 22% were older than 65. Most common regimens were AC-paclitaxel (44%) and FEC-docetaxel (26%). Penetration ranged from 50-86%; 47% of patients had at least one EDH during CT. Mean number of ED+H visits/patient was 0.91 (SD=0.40) in the intervention arm and 0.94 (SD=0.28) in the control arm (p=0.94). There were fewer patients with any grade 3 toxicity in the intervention arm (48% vs 58%, p=0.028), especially fatigue and aching muscles and joints. There was no difference in self-efficacy but patients in the intervention arm had smaller decline in the FACT-TOI during treatment (p=0.004).
Virtual pro-active toxicity management during CH did not lead to fewer EDH but was associated with less grade 3 toxicities and a smaller decline in QoL.
Clinical trial identification
Legal entity responsible for the study
Ontario Clinical Oncology Group.
Ontario Institute for Cancer Research.
M.K. Krzyzanowska: Advisory/ Consultancy, Research grant/Funding (institution): Eisai; Research grant/Funding (institution): Exelixis; Advisory/Consultancy: Bayer. All other authors have declared no conflicts of interest.