A Pragmatic Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer
AToM
A Pragmatic Cluster-Randomized Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer (AToM)
1 other identifier
interventional
1,460
1 country
20
Brief Summary
Comparison of the number of ER plus hospital visits that occurred during chemotherapy between the telephone intervention and control arms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2015
CompletedFirst Posted
Study publicly available on registry
June 30, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedSeptember 3, 2020
September 1, 2020
2.2 years
June 10, 2015
September 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Emergency and Hospital (ED+H) visits during chemotherapy
Collect the number of ED+H visits that occurred during chemotherapy for all patients
During chemotherapy and the 30 days post-chemotherapy
Secondary Outcomes (4)
Severity of Chemotherapy
Assessed at baseline, at day 1 of cycle 2 prior to start of chemotherapy and again within 60 days of the completion of chemotherapy treatment
Quality of Life (QOL)
Assessed at baseline, at day 1 of cycle 2 prior to start of chemotherapy and again within 60 days of the completion of chemotherapy treatment
Coordination of Care
Assessed at baseline, at day 1 of cycle 2 prior to start of chemotherapy and again within 60 days of the completion of chemotherapy treatment
Health Economics
Initiation of chemotherapy to the end of chemotherapy plus 30 days
Study Arms (2)
Proactive Telephone Toxicity Management
EXPERIMENTALProactive Telephone Toxicity Management
Control Arm
ACTIVE COMPARATORControl
Interventions
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.
Centres randomized to the control arm will continue to provide routine care for chemotherapy-related toxicities as is the current standard in the centre.
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.
Eligibility Criteria
You may qualify if:
- Women 18 years of age or older
- Diagnosis of early stage (I-III) breast cancer
- Starting adjuvant or neo-adjuvant chemotherapy within the intervention period at a participating centre
You may not qualify if:
- Currently participating in a clinical trial involving an investigational agent
- Willingness to participate in the study and complete PRO questionnaires as required
- Ability to understand and provide written informed consent
- Language and literacy skills consistent with completing study questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ontario Clinical Oncology Group (OCOG)lead
- University Health Network, Torontocollaborator
- Princess Margaret Hospital, Canadacollaborator
Study Sites (20)
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2, Canada
William Osler Health Centre
Brampton, Ontario, L6R 3J7, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, K7L 5P9, Canada
Grand River Regional Cancer Centre
Kitchener, Ontario, N2G 1G3, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Markham Stouffville
Markham, Ontario, L3P 7P3, Canada
Trillium Health Partners - The Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
Southlake Regional Cancer Centre
Newmarket, Ontario, L3Y 2P9, Canada
R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health
Oshawa, Ontario, L1G 2B9, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Sault Area Hospital
Sault Ste. Marie, Ontario, P6B 0A8, Canada
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, P7B 6V4, Canada
Rouge Valley Health System
Toronto, Ontario, M1E 4B9, Canada
Sunnybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Mt. Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Trillium Health Partners - Queensway Health Centre
Toronto, Ontario, M9C 1A5, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
Related Publications (2)
Krzyzanowska MK, Julian JA, Gu CS, Powis M, Li Q, Enright K, Howell D, Earle CC, Gandhi S, Rask S, Brezden-Masley C, Dent S, Hajra L, Freeman O, Spadafora S, Hamm C, Califaretti N, Trudeau M, Levine MN, Amir E, Bordeleau L, Chiarotto JA, Elser C, Husain J, Laferriere N, Rahim Y, Robinson AG, Vandenberg T, Grunfeld E. Remote, proactive, telephone based management of toxicity in outpatients during adjuvant or neoadjuvant chemotherapy for early stage breast cancer: pragmatic, cluster randomised trial. BMJ. 2021 Dec 8;375:e066588. doi: 10.1136/bmj-2021-066588.
PMID: 34880055DERIVEDKrzyzanowska MK, Julian JA, Powis M, Howell D, Earle CC, Enright KA, Mittmann N, Trudeau ME, Grunfeld E. Ambulatory Toxicity Management (AToM) in patients receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer - a pragmatic cluster randomized trial protocol. BMC Cancer. 2019 Sep 5;19(1):884. doi: 10.1186/s12885-019-6099-x.
PMID: 31488084DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Monika Krzyzanowska, MD
University Health Network - Princess Margaret Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2015
First Posted
June 30, 2015
Study Start
February 1, 2016
Primary Completion
March 29, 2018
Study Completion
June 30, 2020
Last Updated
September 3, 2020
Record last verified: 2020-09