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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.
Krzyzanowska, Monika K; Julian, Jim A; Gu, Chu-Shu; Powis, Melanie; Li, Qing; Enright, Katherine; Howell, Doris; Earle, Craig C; Gandhi, Sonal; Rask, Sara; Brezden-Masley, Christine; Dent, Susan; Hajra, Leena; Freeman, Orit; Spadafora, Silvana; Hamm, Caroline; Califaretti, Nadia; Trudeau, Maureen; Levine, Mark N; Amir, Eitan; Bordeleau, Louise; Chiarotto, James A; Elser, Christine; Husain, Juhi; Laferriere, Nicole; Rahim, Yasmin; Robinson, Andrew G; Vandenberg, Ted; Grunfeld, Eva.
  • Krzyzanowska MK; Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada monika.krzyzanowska@uhn.ca.
  • Julian JA; Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.
  • Gu CS; Ontario Clinical Oncology Group, McMaster University, Hamilton, ON, Canada.
  • Powis M; Ontario Clinical Oncology Group, McMaster University, Hamilton, ON, Canada.
  • Li Q; Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
  • Enright K; Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.
  • Howell D; Trillium Health Partners, Credit Valley Hospital, Mississauga, ON, Canada.
  • Earle CC; Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
  • Gandhi S; Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.
  • Rask S; Ontario Institute for Cancer Research, Toronto, ON, Canada.
  • Brezden-Masley C; Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
  • Dent S; Simcoe Muskoka Regional Cancer Program, Royal Victoria Hospital, Barrier, ON, Canada.
  • Hajra L; St Michael's Hospital, Unity Health, Toronto, ON, Canada.
  • Freeman O; Ottawa Hospital Cancer Centre, Ottawa, ON, Canada.
  • Spadafora S; Markham Stouffville Hospital, Markham, ON, Canada.
  • Hamm C; Durham Regional Cancer Centre, Oshawa, ON, Canada.
  • Califaretti N; Algoma District Cancer Programme, Sault Area Hospital, Sault Ste Marie, ON, Canada.
  • Trudeau M; Windsor Regional Hospital, Windsor, ON, Canada.
  • Levine MN; Grand River Hospital's Regional Cancer Centre, Kitchener, ON, Canada.
  • Amir E; Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
  • Bordeleau L; Ontario Clinical Oncology Group, McMaster University, Hamilton, ON, Canada.
  • Chiarotto JA; Juravinski Cancer Centre, Hamilton, ON, Canada.
  • Elser C; Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
  • Husain J; Juravinski Cancer Centre, Hamilton, ON, Canada.
  • Laferriere N; Scarborough Health Network, Toronto, ON, Canada.
  • Rahim Y; Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
  • Robinson AG; Brampton Civic Hospital, Brampton, ON, Canada.
  • Vandenberg T; Regional Cancer Centre Northwest, Thunder Bay Regional Health Sciences Centre, Thunder Bay, ON, Canada.
  • Grunfeld E; Stronach Regional Cancer Centre, Newmarket, ON, Canada.
BMJ ; 375: e066588, 2021 12 08.
Article in English | MEDLINE | ID: covidwho-1560914
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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Outpatients / Telephone / Breast Neoplasms / Antineoplastic Combined Chemotherapy Protocols / Telemedicine / Monitoring, Ambulatory Type of study: Controlled clinical trial / Prognostic study / Qualitative research / Randomized controlled trials Limits: Adult / Aged / Female / Humans / Middle aged Country/Region as subject: North America Language: English Journal: BMJ Journal subject: Medicine Year: 2021 Document Type: Article Affiliation country: Bmj-2021-066588

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Outpatients / Telephone / Breast Neoplasms / Antineoplastic Combined Chemotherapy Protocols / Telemedicine / Monitoring, Ambulatory Type of study: Controlled clinical trial / Prognostic study / Qualitative research / Randomized controlled trials Limits: Adult / Aged / Female / Humans / Middle aged Country/Region as subject: North America Language: English Journal: BMJ Journal subject: Medicine Year: 2021 Document Type: Article Affiliation country: Bmj-2021-066588