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

NCT02485678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1460

Last updated 2020-09-03

No results posted yet for this study

Summary

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

Conditions

  • Early Stage Breast Cancer

Interventions

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.

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.

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.

Sponsors & Collaborators

  • University Health Network, Toronto

    collaborator OTHER

  • Princess Margaret Hospital, Canada

    collaborator OTHER

  • Ontario Clinical Oncology Group (OCOG)

    lead OTHER

Principal Investigators

  • Monika Krzyzanowska, MD · University Health Network - Princess Margaret Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-03-29
Completion
2020-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02485678 on ClinicalTrials.gov