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

5. november 2022 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

56

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient Engagement (MyChart Accessibility and User Experience)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 3 Months
Patient accrual will be defined by accruing 50 participants within 3 months.
3 Months
MyChart Utilization
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hot Flash Severity (MyChart Feasibility)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ottawa Hospital Research Institute

Etterforskere

  • Hovedetterforsker: Sharon McGee, MD, The Ottawa Hospital Cancer Centre

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. februar 2022

Primær fullføring (Faktiske)

22. juli 2022

Studiet fullført (Faktiske)

22. september 2022

Datoer for studieregistrering

Først innsendt

15. desember 2021

Først innsendt som oppfylte QC-kriteriene

24. januar 2022

Først lagt ut (Faktiske)

3. februar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. november 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2022

Sist bekreftet

1. november 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • REaCT-Hot Flashes Pilot

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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