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

NCT ID: NCT02485678

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2020-06-30

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.

Conditions

Early Stage Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Proactive Telephone Toxicity Management

Proactive Telephone Toxicity Management

Group Type: EXPERIMENTAL

Proactive Telephone Toxicity Management

Intervention Type: OTHER

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.

PRO Sub-Study

Intervention Type: OTHER

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.

Control Arm

Control

Group Type: ACTIVE_COMPARATOR

Control Arm

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• 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

Exclusion Criteria

• Currently participating in a clinical trial involving an investigational agent

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monika Krzyzanowska, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network - Princess Margaret Hospital

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

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 34880055 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31488084 (View on PubMed)

Other Identifiers

OCOG-2015-ATOM

Identifier Type: -

Identifier Source: org_study_id