Remote, proactive, telephone based management of toxicity in outpatients during adjuvant or neoadjuvant chemotherapy for early stage breast cancer: pragmatic, cluster randomised trial

Abstract

Objective To evaluate the effectiveness of remote proactive management of toxicities during chemotherapy for early stage breast cancer. Design Pragmatic, cluster randomised trial. Setting 20 cancer centres in Ontario, Canada, allocated by covariate constrained randomisation to remote management of toxicities or routine care. Participants All patients starting adjuvant or neoadjuvant chemotherapy for early stage breast cancer at each centre. 25 patients from each centre completed patient reported outcome questionnaires. Interventions Proactive, standardised, nurse led telephone management of common toxicities at two time points after each chemotherapy cycle. Main outcome measures The primary outcome, cluster level mean number of visits to the emergency department or admissions to hospital per patient during the whole course of chemotherapy treatment, was evaluated with routinely available administrative healthcare data. Secondary patient reported outcomes included toxicity, self-efficacy, and quality of life. Results Baseline characteristics of participants were similar in the intervention (n=944) and control arms (n=1214); 22% were older than 65 years. Penetration (that is, the percentage of patients who received the intervention at each centre) was 50-86%. Mean number of visits to the emergency department or admissions to hospital per patient was 0.91 (standard deviation 0.28) in the intervention arm and 0.94 (0.40) in the control arm (P=0.94); 47% (1014 of 2158 patients) had at least one visit to the emergency department or a hospital admission during chemotherapy. Among 580 participants who completed the patient reported outcome questionnaires, at least one grade 3 toxicity was reported by 48% (134 of 278 patients) in the intervention arm and by 58% (163 of 283) in the control arm. No differences in self-efficacy, anxiety, or depression were found. Compared with baseline, the functional assessment of cancer therapy trial outcome index decreased by 6.1 and 9.0 points in the intervention and control participants, respectively. Conclusions Proactive, telephone based management of toxicities during chemotherapy did not result in fewer visits to the emergency department or hospital admissions. With the rapid rise in remote care because of the covid-19 pandemic, identifying scalable strategies for remote management of patients during cancer treatment is particularly relevant. Trial registration ClinicalTrials.gov NCT02485678 .

Effect of mHealth interventions on psychological issues experienced by women diagnosed with breast cancer receiving chemotherapy: A systematic review and meta-analysis

“…The 10 included studies were conducted in nine countries: Sweden [47], Japan [48], Taiwan [49], Iran [50, 54], South Korea [51], the United States [52], China [53], Canada [55], and Slovenia [56]. All the studies included a total of 1,548 women with BC undergoing chemotherapy.…”

“…Five of the studies recruited only women with BC undergoing chemotherapy [47-49, 53, 55], the remaining five recruited those receiving other treatments (radiotherapy, surgery, and hormonal therapy) alongside chemotherapy [50-52,54,56].…”

“…Nurses were the interveners in six studies [47-50, 54, 55], whereas in other studies the interventions were delivered by both nurses and doctors [53], a medical doctor [50], graduate-level health professionals [51] and oncologist [56].…”

“…Regarding the delivery mode, the interventions in seven studies were app-based [46-48, 50, 53, 54, 56], one intervention was delivered through an Internet support group [51] and two studies through telephone calls [49,55]. With respect to duration, three studies [47,48,53] administered interventions for 12 weeks, one for three weeks [50], two for four weeks [50, 54], one for six weeks [52], one for 18 weeks [47], one from the beginning of the chemotherapy cycle to 8-10 days after the start of each cycle [55], and one spanned from their first week of treatment to the entire treatment period [56].…”

“…We identified four major components of interventions. All except two [43,56] of the studies had a component for BC education; five had a component for expert consultation [48-50, 53, 54], four had a component for group interaction [49,52-54], and five had a component for the self-reporting of symptoms [47-49, 55, 56]. One intervention also had a game-based learning component [51].…”