Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
| Princess Margaret Hospital, Canada | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Comparison of the number of ER plus hospital visits that occurred during chemotherapy between the telephone intervention and control arms.
Using a pragmatic cluster-randomized trial design, 20 Ontario cancer centres that provide care to patients with breast cancer will be randomly allocated to one of two arms: pro-active telephone toxicity management (intervention), or control (routine care). All patients with early stage (I-III) breast cancer who commence adjuvant or neo-adjuvant chemotherapy at participating institutions during the 6 to 12-month intervention period (will vary between centres depending on the number of incident cases) will be evaluated using Ontario healthcare administrative data. A sub-set of at least 25 patients at each participating institution will participate in a PRO sub-study involving the completion of standardized questionnaires to measure: a) severity of chemotherapy treatment toxicities; b) self-care for management of chemotherapy toxicities; c) self-efficacy (confidence) for managing symptoms; d) quality of life; and e) coordination of care. Patients participating in the PRO sub-study will be asked to provide consent to link their PRO data to Ontario healthcare administrative data so that correlations between the symptom self-assessments and Quality of Life (QoL) measures can be made with the administrative data on ED+H visits and use of supportive care medications. the investigators will compare the use of supportive care medications (i.e. anti-emetics, growth factors) by patients in the intervention and control arms to assess their influence on severity of chemotherapy-related toxicities as part of an exploratory sub-group analysis in patients >65 years of age as administrative data on supportive care medication use is only available for this age group.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proactive Telephone Toxicity Management | Experimental | Proactive Telephone Toxicity Management |
|
| Control Arm | Active Comparator | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proactive Telephone Toxicity Management | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Chemotherapy | Severity of treatment side effects will be measured using the NCI PRO CTCAE self-report tool (assessment on a 5 point scale). | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria for PRO Sub-Study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Monika Krzyzanowska, MD | University Health Network - Princess Margaret Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Hospital | Barrie | Ontario | L4M 6M2 | Canada | ||
| William Osler Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34880055 | Derived | 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. | |
| 31488084 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Control Arm | Other | 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 | Other | 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. |
|
Measured using the Self-Care during Chemotherapy (L-PaSC), Stanford Self-Management Self-Efficacy Scale, FACT-B, GAD-7, PHQ-9, EQ-5D-3L |
| 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 | Measured using the adapted Picker survey. | 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 | Health system resources utilized by women receiving adjuvant or neo-adjuvant chemotherapy will be analyzed | Initiation of chemotherapy to the end of chemotherapy plus 30 days |
| 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 |
| Derived |
| Krzyzanowska 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. |