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

Early Stage Breast Cancer Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02485678
Study type Interventional
Source Ontario Clinical Oncology Group (OCOG)
Contact
Status Completed
Phase N/A
Start date February 2016
Completion date June 30, 2020
View Details
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