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

NCT05222464 | Completed Phase 4

• 1 other identifier: REaCT-Hot Flashes Pilot
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Vasomotor Symptoms; Machine Learning

Outcome Measures

Primary Outcomes (4)

• Patient Engagement (MyChart Accessibility and User Experience)

  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)

  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)

  Patient accrual will be defined by accruing 50 participants within 3 months.

  3 Months

• MyChart Utilization

  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 Outcomes (5)

• Hot Flash Severity (MyChart Feasibility)

  3 Months

• MyChart Feasibility in assessing effectiveness of interventions for VMS

  3 months

• Effectiveness of Interventions for VMS - Traditional Statistical Modeling

  3 Months

• Effectiveness of interventions for VMS (MyChart feasibility)

  3 Months

• Predicting effectiveness of interventions for VMS - machine learning

  3 Months

Study Arms (1)

Standard of Care Intervention

OTHER

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

Standard of care treatments OTHER

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.

Standard of Care Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Those who are unable to complete questionnaires in English

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Location

Related Publications (4)

• Cole KM, Clemons M, McGee S, Alzahrani M, Larocque G, MacDonald F, Liu M, Pond GR, Mosquera L, Vandermeer L, Hutton B, Piper A, Fernandes R, Emam KE. Using machine learning to predict individual patient toxicities from cancer treatments. Support Care Cancer. 2022 Sep;30(9):7397-7406. doi: 10.1007/s00520-022-07156-6. Epub 2022 May 25.

  PMID: 35614153 BACKGROUND

• Hutton B, Hersi M, Cheng W, Pratt M, Barbeau P, Mazzarello S, Ahmadzai N, Skidmore B, Morgan SC, Bordeleau L, Ginex PK, Sadeghirad B, Morgan RL, Cole KM, Clemons M. Comparing Interventions for Management of Hot Flashes in Patients With Breast and Prostate Cancer: A Systematic Review With Meta-Analyses. Oncol Nurs Forum. 2020 Jul 1;47(4):E86-E106. doi: 10.1188/20.ONF.E86-E106.

  PMID: 32555553 BACKGROUND

• Cole KM, Clemons M, Alzahrani M, Larocque G, MacDonald F, Vandermeer L, Hutton B, Piper A, Pond G, McGee S. Developing patient-centred strategies to optimize the management of vasomotor symptoms in breast cancer patients: a survey of health care providers. Breast Cancer Res Treat. 2021 Jul;188(2):343-350. doi: 10.1007/s10549-021-06186-8. Epub 2021 Jun 22.

  PMID: 34159473 BACKGROUND

• Cole KM, McGee S, Clemons M, Liu M, MacDonald F, Vandermeer L, Ng TL, Pond G, Emam KE. Development and application of a weighted change score to evaluate interventions for vasomotor symptoms in patients with breast cancer using regression trees: a cohort study. Breast Cancer Res Treat. 2024 Sep;207(2):313-321. doi: 10.1007/s10549-024-07360-4. Epub 2024 May 19.

  PMID: 38763972 RESULT

Related Links

• The Rethinking Clinical Trials (REaCT) website

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sharon McGee, MD

  The Ottawa Hospital Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: February 3, 2022
• Study Start: February 25, 2022
• Primary Completion: July 22, 2022
• Study Completion: September 22, 2022
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

CA (1)