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

Early Stage Breast Cancer Clinical Trial

— AToM  

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 Details — Status: Completed

Administrative data

• NCT number: NCT02485678
• Other study ID #: OCOG-2015-ATOM
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2020
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1460
• Est. completion date: June 30, 2020
• Est. primary completion date: March 29, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Stage Breast Cancer

Intervention

Other:
• Proactive Telephone Toxicity Management
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.
• Control Arm
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
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.

Locations

Country	Name	City	State
Canada	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	Mt. Sinai Hospital	Toronto	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Rouge Valley Health System	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre, Odette Cancer Centre	Toronto	Ontario
Canada	Trillium Health Partners - Queensway Health Centre	Toronto	Ontario
Canada	Windsor Regional Cancer Centre	Windsor	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Princess Margaret Hospital, Canada, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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