Clinical trial NCT02485678: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Stage Breast Cancer
Keywords: ambulatory toxicity management
adjuvant or neoadjuvant chemotherapy
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: Princess Margaret Hospital, Canada
First posted: 2015-06-30
Enrollment: 1460
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 criteria: 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

Primary outcomes:
measure: Number of Emergency and Hospital (ED+H) visits during chemotherapy
timeFrame: During chemotherapy and the 30 days post-chemotherapy
Secondary outcomes:
measure: Severity of Chemotherapy
timeFrame: 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
measure: Quality of Life (QOL)
timeFrame: 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
measure: Coordination of Care
timeFrame: 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
measure: Health Economics
timeFrame: Initiation of chemotherapy to the end of chemotherapy plus 30 days
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: Royal Victoria Hospital
state: Ontario
city: Brampton
country: Canada
facility: William Osler Health Centre
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario at Kingston
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Regional Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Markham
country: Canada
facility: Markham Stouffville
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners - The Credit Valley Hospital
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Cancer Centre
state: Ontario
city: Oshawa
country: Canada
facility: R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Regional Cancer Centre
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Sault Area Hospital
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Science Centre
state: Ontario
city: Toronto
country: Canada
facility: Rouge Valley Health System
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre, Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mt. Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Trillium Health Partners - Queensway Health Centre
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network - Princess Margaret Hospital
name: Monika Krzyzanowska, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.