1,460
Participants
Start Date
February 29, 2016
Primary Completion Date
March 29, 2018
Study Completion Date
June 30, 2020
Proactive Telephone Toxicity Management
Centres randomized to this arm will implement a pro-active telephone toxicity management program, for all eligible early stage breast cancer patients beginning neo-adjuvant or adjuvant chemotherapy within the intervention period until the end of their systemic treatment. Patients will receive a phone call from a local nurse who has been trained on the toxicity management toolkit at 24-72 hours and at 8 to 10 days following each chemotherapy administration. The provider conducting the call will be provided with a script and will complete the Telephone Follow-Up Questionnaire which includes questions from the abbreviated NCI PRO-CTCAE tool. The nurse conducting the call will also be provided with the provider version of the symptom management booklet and provide toxicity management counseling. If any toxicity-related problems are identified during the call, a second call will take place 24 hours after the initial call to ensure the problem is resolving or to provide additional support.
Control Arm
Centres randomized to the control arm will continue to provide routine care for chemotherapy-related toxicities as is the current standard in the centre.
PRO Sub-Study
A sub-set of approximately 25 patients enrolled at each participating centre will participate in a Patient Reported Outcomes (PRO) sub-study to assess the effect of the intervention on secondary outcomes.
Royal Victoria Hospital, Barrie
William Osler Health Centre, Brampton
Juravinski Cancer Centre, Hamilton
Cancer Centre of Southeastern Ontario at Kingston, Kingston
Grand River Regional Cancer Centre, Kitchener
London Regional Cancer Program, London
Markham Stouffville, Markham
Trillium Health Partners - The Credit Valley Hospital, Mississauga
Southlake Regional Cancer Centre, Newmarket
R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health, Oshawa
The Ottawa Hospital Regional Cancer Centre, Ottawa
Sault Area Hospital, Sault Ste. Marie
Thunder Bay Regional Health Science Centre, Thunder Bay
Rouge Valley Health System, Toronto
Sunnybrook Health Sciences Centre, Odette Cancer Centre, Toronto
St. Michael's Hospital, Toronto
Mt. Sinai Hospital, Toronto
Princess Margaret Cancer Centre, Toronto
Trillium Health Partners - Queensway Health Centre, Toronto
Windsor Regional Cancer Centre, Windsor
University Health Network, Toronto
OTHER
Princess Margaret Hospital, Canada
OTHER
Ontario Clinical Oncology Group (OCOG)
OTHER