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

5 novembre 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

56

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Patient Engagement (MyChart Accessibility and User Experience)
Délai: 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)
Délai: 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)
Délai: 3 Months
Patient accrual will be defined by accruing 50 participants within 3 months.
3 Months
MyChart Utilization
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Hot Flash Severity (MyChart Feasibility)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ottawa Hospital Research Institute

Les enquêteurs

  • Chercheur principal: Sharon McGee, MD, The Ottawa Hospital Cancer Centre

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

25 février 2022

Achèvement primaire (Réel)

22 juillet 2022

Achèvement de l'étude (Réel)

22 septembre 2022

Dates d'inscription aux études

Première soumission

15 décembre 2021

Première soumission répondant aux critères de contrôle qualité

24 janvier 2022

Première publication (Réel)

3 février 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 novembre 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 novembre 2022

Dernière vérification

1 novembre 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • REaCT-Hot Flashes Pilot

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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