Randomized Controlled Trial

. 2021 Dec 8:375:e066588.

doi: 10.1136/bmj-2021-066588.

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

Monika K Krzyzanowska^{1

2}, Jim A Julian³, Chu-Shu Gu³, Melanie Powis⁴, Qing Li², Katherine Enright⁵, Doris Howell⁴, Craig C Earle^{2

6}, Sonal Gandhi⁷, Sara Rask⁸, Christine Brezden-Masley⁹, Susan Dent¹⁰, Leena Hajra¹¹, Orit Freeman¹², Silvana Spadafora¹³, Caroline Hamm¹⁴, Nadia Califaretti¹⁵, Maureen Trudeau⁷, Mark N Levine^{3

16}, Eitan Amir⁴, Louise Bordeleau¹⁶, James A Chiarotto¹⁷, Christine Elser⁴, Juhi Husain¹⁸, Nicole Laferriere¹⁹, Yasmin Rahim²⁰, Andrew G Robinson²¹, Ted Vandenberg²², Eva Grunfeld^{6

23}

Affiliations

¹ Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada monika.krzyzanowska@uhn.ca.
² Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.
³ Ontario Clinical Oncology Group, McMaster University, Hamilton, ON, Canada.
⁴ Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
⁵ Trillium Health Partners, Credit Valley Hospital, Mississauga, ON, Canada.
⁶ Ontario Institute for Cancer Research, Toronto, ON, Canada.
⁷ Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
⁸ Simcoe Muskoka Regional Cancer Program, Royal Victoria Hospital, Barrier, ON, Canada.
⁹ St Michael's Hospital, Unity Health, Toronto, ON, Canada.
¹⁰ Ottawa Hospital Cancer Centre, Ottawa, ON, Canada.
¹¹ Markham Stouffville Hospital, Markham, ON, Canada.
¹² Durham Regional Cancer Centre, Oshawa, ON, Canada.
¹³ Algoma District Cancer Programme, Sault Area Hospital, Sault Ste Marie, ON, Canada.
¹⁴ Windsor Regional Hospital, Windsor, ON, Canada.
¹⁵ Grand River Hospital's Regional Cancer Centre, Kitchener, ON, Canada.
¹⁶ Juravinski Cancer Centre, Hamilton, ON, Canada.
¹⁷ Scarborough Health Network, Toronto, ON, Canada.
¹⁸ Brampton Civic Hospital, Brampton, ON, Canada.
¹⁹ Regional Cancer Centre Northwest, Thunder Bay Regional Health Sciences Centre, Thunder Bay, ON, Canada.
²⁰ Stronach Regional Cancer Centre, Newmarket, ON, Canada.
²¹ Kingston General Hospital, Kingston, ON, Canada.
²² Lawson Health Research Institute, London, ON, Canada.
²³ Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada.

PMID: 34880055
PMCID: PMC8652580
DOI: 10.1136/bmj-2021-066588

Randomized Controlled Trial

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

Monika K Krzyzanowska et al. BMJ. 2021.

. 2021 Dec 8:375:e066588.

doi: 10.1136/bmj-2021-066588.

Authors

Affiliations

¹ Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada monika.krzyzanowska@uhn.ca.
² Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.
³ Ontario Clinical Oncology Group, McMaster University, Hamilton, ON, Canada.
⁴ Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
⁵ Trillium Health Partners, Credit Valley Hospital, Mississauga, ON, Canada.
⁶ Ontario Institute for Cancer Research, Toronto, ON, Canada.
⁷ Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
⁸ Simcoe Muskoka Regional Cancer Program, Royal Victoria Hospital, Barrier, ON, Canada.
⁹ St Michael's Hospital, Unity Health, Toronto, ON, Canada.
¹⁰ Ottawa Hospital Cancer Centre, Ottawa, ON, Canada.
¹¹ Markham Stouffville Hospital, Markham, ON, Canada.
¹² Durham Regional Cancer Centre, Oshawa, ON, Canada.
¹³ Algoma District Cancer Programme, Sault Area Hospital, Sault Ste Marie, ON, Canada.
¹⁴ Windsor Regional Hospital, Windsor, ON, Canada.
¹⁵ Grand River Hospital's Regional Cancer Centre, Kitchener, ON, Canada.
¹⁶ Juravinski Cancer Centre, Hamilton, ON, Canada.
¹⁷ Scarborough Health Network, Toronto, ON, Canada.
¹⁸ Brampton Civic Hospital, Brampton, ON, Canada.
¹⁹ Regional Cancer Centre Northwest, Thunder Bay Regional Health Sciences Centre, Thunder Bay, ON, Canada.
²⁰ Stronach Regional Cancer Centre, Newmarket, ON, Canada.
²¹ Kingston General Hospital, Kingston, ON, Canada.
²² Lawson Health Research Institute, London, ON, Canada.
²³ Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada.

PMID: 34880055
PMCID: PMC8652580
DOI: 10.1136/bmj-2021-066588

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.

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Conflict of interest statement

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.

Figures

**Fig 1**
CONSORT (Consolidated Standards of Reporting Trials) diagram

**Fig 2**
Distribution of visits to the emergency department or admissions to hospital per patient by size of centre and overall

See this image and copyright information in PMC

References

1. Enright K, Grunfeld E, Yun L, et al. . Population-based assessment of emergency room visits and hospitalizations among women receiving adjuvant chemotherapy for early breast cancer. J Oncol Pract 2015;11:126-32. 10.1200/JOP.2014.001073 - DOI - PubMed
1. Pittman NM, Hopman WM, Mates M. Emergency room visits and hospital admission rates after curative chemotherapy for breast cancer. J Oncol Pract 2015;11:120-5. 10.1200/JOP.2014.000257 - DOI - PubMed
1. Eskander A, Krzyzanowska MK, Fischer HD, et al. . Emergency department visits and unplanned hospitalizations in the treatment period for head and neck cancer patients treated with curative intent: A population-based analysis. Oral Oncol 2018;83:107-14. 10.1016/j.oraloncology.2018.06.011 - DOI - PubMed
1. Prince RM, Powis M, Zer A, Atenafu EG, Krzyzanowska MK. Hospitalisations and emergency department visits in cancer patients receiving systemic therapy: Systematic review and meta-analysis. Eur J Cancer Care (Engl) 2019;28:e12909. 10.1111/ecc.12909 - DOI - PubMed
1. Mooney KH, Beck SL, Friedman RH, Farzanfar R. Telephone-linked care for cancer symptom monitoring: a pilot study. Cancer Pract 2002;10:147-54. 10.1046/j.1523-5394.2002.103006.x - DOI - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Associated data

LinkOut - more resources

Full Text Sources

Medical