Spots Global Cancer Trial Database for A Pragmatic Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer
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Trial Identification
Brief Title: A Pragmatic Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer
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)
Study ID: NCT02485678
Conditions
Study Description
Brief Summary: Comparison of the number of ER plus hospital visits that occurred during chemotherapy between the telephone intervention and control arms.
Detailed 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Royal Victoria Hospital, Barrie, Ontario, Canada
William Osler Health Centre, Brampton, Ontario, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario, Canada
Grand River Regional Cancer Centre, Kitchener, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Markham Stouffville, Markham, Ontario, Canada
Trillium Health Partners - The Credit Valley Hospital, Mississauga, Ontario, Canada
Southlake Regional Cancer Centre, Newmarket, Ontario, Canada
R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health, Oshawa, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada
Sault Area Hospital, Sault Ste. Marie, Ontario, Canada
Thunder Bay Regional Health Science Centre, Thunder Bay, Ontario, Canada
Rouge Valley Health System, Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre, Odette Cancer Centre, Toronto, Ontario, Canada
St. Michael's Hospital, Toronto, Ontario, Canada
Mt. Sinai Hospital, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Trillium Health Partners - Queensway Health Centre, Toronto, Ontario, Canada
Windsor Regional Cancer Centre, Windsor, Ontario, Canada
Contact Details
Name: Monika Krzyzanowska, MD
Affiliation: University Health Network - Princess Margaret Hospital
Role: PRINCIPAL_INVESTIGATOR
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