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

Study Overview
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Brief Summary
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Comparison of the number of ER plus hospital visits that occurred during chemotherapy between the telephone intervention and control arms.

Detailed Description
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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.

Official Title
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A Pragmatic Cluster-Randomized Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer (AToM)

Conditions
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Early Stage Breast Cancer

Intervention / Treatment
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* Other: Proactive Telephone Toxicity Management
* Other: Control Arm
* Other: PRO Sub-Study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Currently participating in a clinical trial involving an investigational agent Inclusion Criteria for PRO Sub-Study 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proactive Telephone Toxicity Management<br>Proactive Telephone Toxicity Management | Other: Proactive Telephone Toxicity Management<br>* 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.<br>Other: PRO Sub-Study<br>* 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.<br>|
| Active Comparator: Control Arm<br>Control | Other: Control Arm<br>* Centres randomized to the control arm will continue to provide routine care for chemotherapy-related toxicities as is the current standard in the centre.<br>Other: PRO Sub-Study<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ambulatory toxicity management, adjuvant or neoadjuvant chemotherapy