Remote, proactive, telephone based management of toxicity in outpatients during adjuvant or neoadjuvant chemotherapy for early stage breast cancer: pragmatic, cluster randomised trial.
| Title: | Remote, proactive, telephone based management of toxicity in outpatients during adjuvant or neoadjuvant chemotherapy for early stage breast cancer: pragmatic, cluster randomised trial. |
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| Authors: | Krzyzanowska MK; Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada monika.krzyzanowska@uhn.ca.; Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.; Julian JA; Ontario Clinical Oncology Group, McMaster University, Hamilton, ON, Canada.; Gu CS; Ontario Clinical Oncology Group, McMaster University, Hamilton, ON, Canada.; Powis M; Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.; Li Q; Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.; Enright K; Trillium Health Partners, Credit Valley Hospital, Mississauga, ON, Canada.; Howell D; Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.; Earle CC; Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.; Ontario Institute for Cancer Research, Toronto, ON, Canada.; Gandhi S; Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.; Rask S; Simcoe Muskoka Regional Cancer Program, Royal Victoria Hospital, Barrier, ON, Canada.; Brezden-Masley C; St Michael's Hospital, Unity Health, Toronto, ON, Canada.; Dent S; Ottawa Hospital Cancer Centre, Ottawa, ON, Canada.; Hajra L; Markham Stouffville Hospital, Markham, ON, Canada.; Freeman O; Durham Regional Cancer Centre, Oshawa, ON, Canada.; Spadafora S; Algoma District Cancer Programme, Sault Area Hospital, Sault Ste Marie, ON, Canada.; Hamm C; Windsor Regional Hospital, Windsor, ON, Canada.; Califaretti N; Grand River Hospital's Regional Cancer Centre, Kitchener, ON, Canada.; Trudeau M; Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.; Levine MN; Ontario Clinical Oncology Group, McMaster University, Hamilton, ON, Canada.; Juravinski Cancer Centre, Hamilton, ON, Canada.; Amir E; Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.; Bordeleau L; Juravinski Cancer Centre, Hamilton, ON, Canada.; Chiarotto JA; Scarborough Health Network, Toronto, ON, Canada.; Elser C; Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.; Husain J; Brampton Civic Hospital, Brampton, ON, Canada.; Laferriere N; Regional Cancer Centre Northwest, Thunder Bay Regional Health Sciences Centre, Thunder Bay, ON, Canada.; Rahim Y; Stronach Regional Cancer Centre, Newmarket, ON, Canada.; Robinson AG; Kingston General Hospital, Kingston, ON, Canada.; Vandenberg T; Lawson Health Research Institute, London, ON, Canada.; Grunfeld E; Ontario Institute for Cancer Research, Toronto, ON, Canada.; Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada. |
| Source: | BMJ (Clinical research ed.) [BMJ] 2021 Dec 08; Vol. 375, pp. e066588. Date of Electronic Publication: 2021 Dec 08. |
| Publication Type: | Journal Article; Multicenter Study; Pragmatic Clinical Trial; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| Language: | English |
| Journal Info: | Publisher: British Medical Association Country of Publication: England NLM ID: 8900488 Publication Model: Electronic Cited Medium: Internet ISSN: 1756-1833 (Electronic) Linking ISSN: 09598138 NLM ISO Abbreviation: BMJ Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: London : British Medical Association |
| MeSH Terms: | Outpatients* ; Telemedicine* ; Telephone*; Antineoplastic Combined Chemotherapy Protocols/*administration & dosage ; Breast Neoplasms/*drug therapy ; Monitoring, Ambulatory/*methods; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Breast Neoplasms/psychology ; Chemotherapy, Adjuvant/adverse effects ; Emergency Service, Hospital/statistics & numerical data ; Adult ; Aged ; Aged, 80 and over ; COVID-19 ; Drug-Related Side Effects and Adverse Reactions ; Female ; Humans ; Middle Aged ; Ontario ; Pandemics ; Quality of Life ; SARS-CoV-2 ; Surveys and Questionnaires ; Treatment Outcome |
| 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.; (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
| Competing Interests: | Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the Ontario Institute for Cancer Research (OICR) for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; CCE and EG hold appointments at the OICR Health Services Research Programme; no other relationships or activities that could appear to have influenced the submitted work. |
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| Molecular Sequence: | ClinicalTrials.gov NCT02485678 |
| Entry Date(s): | Date Created: 20211209 Date Completed: 20211214 Latest Revision: 20211223 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC8652580 |
| DOI: | 10.1136/bmj-2021-066588 |
| PMID: | 34880055 |
| Database: | MEDLINE |
Journal Article; Multicenter Study; Pragmatic Clinical Trial; Randomized Controlled Trial; Research Support, Non-U.S. Gov't