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Recruiting
View on ClinicalTrials.gov

Testing At-home Breast Oncology care Delivered for patient engagement

Official title: At-home Breast Oncology Care Delivered With E-health Solutions

At-home Breast Oncology Care Delivered With E-health Solutions The ABODE Study

Condition: Patient EngagementSponsor: University Health Network, TorontoTarget enrollment: 200
  • 2 groups
  • One site, in Toronto
  • Recruiting
Tulin Cil, Toronto, Ontario

Interventions

  • Other intervention

    At-home Breast Oncology care Delivered with E-health solutions - ABODE

    The development and implementation of the Breast Cancer Treatment Application (BCTA) will facilitate a secure approach to virtual care for Breast Cancer patients, provide patient specific treatment education and facilitate evaluation of Patient Reported Outcome Measures.

Canadian Sites (1)

1 of 1 recruiting

  • Tulin Cil

    Toronto, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for13 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Females (assigned female at birth)\*
  • +Diagnosed with first, primary invasive BC
  • +Access to an electronic device with connection to the internet
  • +A valid email address
  • +Can communicate in English \*Since BC risk is sex-related and based on physiological values, our inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → are based on sex (not gender)
  • +Must have surgery as their first step in treatment pathway

Exclusion

  • Males (assigned male at birth), as BC surgical treatment options and experiences are different
  • Diagnosed with non-operable breast cancer
  • Those with hearing or visual challenges
  • Should not be enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in any other UHN study using an e-Health application
  • Stage 4/metastatic (whether determined at diagnosis or during surgery)
  • Neo-adjuvant chemotherapy
  • Breast cancer surgery is scheduled for less 5 business days after enrollment
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to improve comfort and quality of life alongside other care.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives no study treatment and is followed for comparison.

Registry label: A: Control Arm

Group B receives At-home Breast Oncology care Delivered with E-health solutions - ABODE.

Registry label: B: Interventional Arm

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives no study treatment at all, and is followed for comparison.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study lists female participants only.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 200 people.

The study is currently expected to finish around June 2026.

The main measurement is taken over: At baselineBaselineYour starting measurements, taken before treatment begins.Read more →, 6 months and 12 months after enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Primary Objective — measured over At baselineBaselineYour starting measurements, taken before treatment begins.Read more →, 6 months and 12 months after enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05989477 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About At-home Breast Oncology care Delivered with E-health solutions - ABODEOther

The development and implementation of the Breast Cancer Treatment Application (BCTA) will facilitate a secure approach to virtual care for Breast Cancer patients, provide patient specific treatment education and facilitate evaluation of Patient Reported Outcome Measures.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives no study treatment and is followed for comparison.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It lists female participants only.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: At baselineBaselineYour starting measurements, taken before treatment begins.Read more →, 6 months and 12 months after enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.

The study as a whole is currently expected to finish around 2026-06-22.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 200 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Toronto, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

The COVID-19 pandemic has significantly impacted healthcare service delivery, highlighting the need for high quality virtual patient care. Our team has developed a multi-dimensional remote eHealth solution for newly diagnosed breast cancer patients and their practitioners to use during the diagnostic and follow-up period. The ABODE study involved development of a Breast Cancer Treatment Application (app) which will facilitate virtual consultations, deliver patient education material, and collect patient reported outcome measures (PROMs). Using a randomized controlled trial design, the team will evaluate a variety of outcomes for breast cancer patients who will use the app throughout their diagnosis and treatment period. Primary Objective: To compare changes in patient activation (assessed by PAM-13) over 1 year among newly diagnosed breast cancer patients between those using the app and those receiving standard care. Secondary Objectives: 1. Compare additional PROMs between the standard care and intervention groups 2. Describe health service outcomes among app users 3. Explore end-user experience of using the app 4. Measure activity levels using wearable devices

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.