Utilizing MyChart to Assess the Effectiveness of Interventions for Vasomotor Symptoms: A Feasibility Study

December 17, 2025 updated by: Ottawa Hospital Research Institute

Utilizing MyChart to Assess the Effectiveness of Interventions for Vasomotor Symptoms: A Feasibility Study (REaCT-Hot Flashes Pilot)

Vasomotor symptoms (VMS) are a common consequence of systemic therapies for breast cancer. Breast cancer treatments can cause VMS in approximately 30% of postmenopausal women and 95% of premenopausal women with early stage breast cancer (EBC). There are many non-estrogen-based interventions available to manage VMS, including; lifestyle modifications, complementary and alternative medicine (CAM) therapies. However, a recent systematic review and meta-analysis of pharmacological and CAM interventions conducted by our team, found no single optimal treatment for VMS management in breast cancer patients. Given the complex patient, cancer and treatment variables influencing the experience of VMS, the numerous potentially effective VMS interventions available and the varying expectations for an effective intervention, the investigators believe Machine Learning (ML) is ideally suited to the analysis of this common and bothersome treatment related toxicity. The EPIC electronic medical record, and MyChart application has provided both clinicians and patients with increased tools for the documentation of health related outcomes. The investigators believe that the MyChart platform, and ML techniques can be utilized to collect, and analyze outcome data for breast cancer patients experiencing VMS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vasomotor symptoms (VMS) are a common consequence of systemic therapies for breast cancer. Breast cancer treatments can cause VMS in approximately 30% of postmenopausal women and 95% of premenopausal women with early stage breast cancer (EBC). In addition to their negative impact on quality of life, unmanaged VMS are the most common reason for discontinuation of potentially curative treatment in 25-60% of EBC patients. Estrogen replacement is a common treatment for VMS in the general population, however, it is contraindicated in breast cancer patients. There are many non-estrogen-based interventions available to manage VMS, including; lifestyle modifications, complementary and alternative medicine (CAM) therapies. However, a recent systematic review and meta-analysis of pharmacological and CAM interventions conducted by our team, found no single optimal treatment for VMS management in breast cancer patients. The investigators recently conducted a survey in 373 patients with EBC which found that while the majority of patients were interested in receiving an intervention to mitigate their symptoms, only 18% received a treatment for this problem. In addition, more than one third of patients experiencing VMS report that they are not routinely asked about their symptoms in routine follow up. Given the complex patient, cancer and treatment variables influencing the experience of VMS, the numerous potentially effective VMS interventions available and the varying expectations for an effective intervention, the investigators believe Machine Learning (ML) is ideally suited to the analysis of this common and bothersome treatment related toxicity. Prior breast cancer studies have successfully applied to ML models to examine risk of developing breast cancer, as well as breast cancer prognosis. The EPIC electronic medical record, and MyChart application has provided both clinicians and patients with increased tools for the documentation of health related outcomes. The investigators believe that the MyChart platform, and ML techniques can be utilized to collect, and analyze outcome data for breast cancer patients experiencing VMS.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients over the age of 18 who have histologically confirmed breast cancer, of any stage
  • Patients experiencing vasomotor symptoms
  • While the study is intended to evaluate the feasibility of the MyChart platform, patients without a MyChart account, who are interested in participating in the study, will have access to a paper or electronic email version. As participation in the MyChart program has benefits outside of this intended study, all patients without a MyChart account will be encouraged to sign up for the service

Exclusion Criteria:

  • Those who are unable to complete questionnaires in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard of Care Intervention
Standard of care intervention - The intervention will consist of 4 classes of standard of care treatments, namely, lifestyle modifications, complementary and alternative medicine (CAM) therapies, prescription medications, or adjustment of anti-cancer therapy.
Other: Standard of care treatments
Interventions will consist of 4 classes of standard of care treatments, namely, lifestyle modifications, complementary and alternative medicine (CAM) therapies, prescription medications, or adjustment of anti-cancer therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Engagement (MyChart Accessibility and User Experience)
Time Frame: 3 Months
Patient engagement will be defined by 60% of patients approached agreeing to participate in the study.
3 Months
Physician Engagement (MyChart Accessibility and User Experience)
Time Frame: 3 Months
Physician engagement will be defined by 60% of those completing the study log to approach patients for participation in study.
3 Months
Patient Accrual (MyChart Accessibility and User Experience)
Time Frame: 3 Months
Patient accrual will be defined by accruing 50 participants within 3 months.
3 Months
MyChart Utilization
Time Frame: Baseline and 6 weeks
MyChart utilization will be defined as 85% of participants completing both questionnaires (the Hot Flash Problem Score and the Composite Hot Flash Score) on the MyChart interface, and 50% of enrolled participants completing both questionnaires as per study protocol.
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hot Flash Severity (MyChart Feasibility)
Time Frame: 3 Months
Hot flash severity (MyChart feasibility) will be assessed by the Hot Flash Problem Score, a composite score of the perceived distress, interference, and problematic nature of vasomotor symptoms (VMS) in daily life and by the composite hot flash score (assess hot flashes on a daily basis for 7 days). The researchers will assess the feasibility of using MyChart to complete hot flash severity assessments by determining the percentage of participants who complete the tools as per protocol, including the percentage of patients who complete daily assessments over the 7 day period.
3 Months
MyChart Feasibility in assessing effectiveness of interventions for VMS
Time Frame: 3 months
The investigators will assess the effectiveness of an intervention by assessing change in hot flash severity scores using the Hot Flash Problem Score, and composite hot flash score from baseline to 6 weeks post intervention.
3 months
Effectiveness of Interventions for VMS - Traditional Statistical Modeling
Time Frame: 3 Months
Analyze MyChart questionnaire response data, using traditional statistical modelling (including linear and logistic regression models) to predict change in hot flash severity outcomes in response to interventions for VMS. The severity outcomes will be based on two validated clinical tools. These tools consist of the Hot Flash Problem Score (a composite score of the perceived distress, interference, and problematic nature of VMS in daily life), and Composite Hot Flash Score (this assess hot flashes on a daily basis for 7 days).
3 Months
Effectiveness of interventions for VMS (MyChart feasibility)
Time Frame: 3 Months
Effectiveness of interventions for VMS (MyChart feasibility) will be assessed by frequency of nocturnal awakenings, and toxicity data. Data will be analyzed using traditional statistics and machine learning techniques to create a preliminary model predicting VMS treatment response in individuals.
3 Months
Predicting effectiveness of interventions for VMS - machine learning
Time Frame: 3 Months
Utilize machine learning models, including classification and regression trees, with comparison against standard regression models, to assess for improvements in predictive power for hot flash severity. The researchers will use model explainability techniques, such as conditional dependence plots, to study the impact of specific features on the hot flash severity outcomes.
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Sharon McGee, MD, The Ottawa Hospital Cancer Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2022

Primary Completion (Actual)

July 22, 2022

Study Completion (Actual)

September 22, 2022

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

January 24, 2022

First Posted (Actual)

February 3, 2022

Study Record Updates

Last Update Posted (Estimated)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REaCT-Hot Flashes Pilot

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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