A Pragmatic Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer

NACompletedINTERVENTIONAL
Enrollment

1,460

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

March 29, 2018

Study Completion Date

June 30, 2020

Conditions
Early Stage Breast Cancer
Interventions
OTHER

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.

OTHER

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.

OTHER

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.

Trial Locations (20)

L4M 6M2

Royal Victoria Hospital, Barrie

L6R 3J7

William Osler Health Centre, Brampton

L8V 5C2

Juravinski Cancer Centre, Hamilton

K7L 5P9

Cancer Centre of Southeastern Ontario at Kingston, Kingston

N2G 1G3

Grand River Regional Cancer Centre, Kitchener

N6A 4L6

London Regional Cancer Program, London

L3P 7P3

Markham Stouffville, Markham

L5M 2N1

Trillium Health Partners - The Credit Valley Hospital, Mississauga

L3Y 2P9

Southlake Regional Cancer Centre, Newmarket

L1G 2B9

R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health, Oshawa

K1H 8L6

The Ottawa Hospital Regional Cancer Centre, Ottawa

P6B 0A8

Sault Area Hospital, Sault Ste. Marie

P7B 6V4

Thunder Bay Regional Health Science Centre, Thunder Bay

M1E 4B9

Rouge Valley Health System, Toronto

M4N 3M5

Sunnybrook Health Sciences Centre, Odette Cancer Centre, Toronto

M5B 1W8

St. Michael's Hospital, Toronto

M5G 1X5

Mt. Sinai Hospital, Toronto

M5G 2M9

Princess Margaret Cancer Centre, Toronto

M9C 1A5

Trillium Health Partners - Queensway Health Centre, Toronto

N8W 2X3

Windsor Regional Cancer Centre, Windsor

All Listed Sponsors
collaborator

University Health Network, Toronto

OTHER

collaborator

Princess Margaret Hospital, Canada

OTHER

lead

Ontario Clinical Oncology Group (OCOG)

OTHER

NCT02485678 - A Pragmatic Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer | Biotech Hunter | Biotech Hunter