On-demand personalized follow-up care for Breast Cancer

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
The Ottawa Hospital Cancer Centre, Ottawa, Canada
Breast Cancer+1 More
On-demand personalized follow-up care - Other
Eligibility
18+
Female
What conditions do you have?
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Study Summary

After breast cancer patients complete the acute phase of their treatment (i.e. surgery, chemotherapy and/or radiation therapy), they are routinely followed in clinic every 3-6 months for several years. Multiple guideline recommendations exist with no consensus on the optimal follow-up schedule due to lack of randomized data to support any particular follow-up recommendation. Therefore the investigators propose a randomized trial evaluating personalized vs guideline-based well follow-up strategies for patients with early-stage breast cancer.

Eligible Conditions

  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 24 months after randomization

24 months after randomization
Anxiety levels
Cost-effectiveness
Fear of recurrence
Health-Related Quality of Life
Patient visits
Recurrence-free survival
Treatment related toxicity concerns

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

On-demand personalized follow-up care
1 of 2
Guideline-based follow-up care
1 of 2
Active Control

228 Total Participants · 2 Treatment Groups

Primary Treatment: On-demand personalized follow-up care · No Placebo Group · Phase 4

On-demand personalized follow-up care
Other
ActiveComparator Group · 1 Intervention: On-demand personalized follow-up care · Intervention Types: Other
Guideline-based follow-up care
Other
ActiveComparator Group · 1 Intervention: Guideline-based follow-up care (standard of care) · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months after randomization
Closest Location: The Ottawa Hospital Cancer Centre · Ottawa, Canada
Photo of Ottawa 1Photo of Ottawa 2Photo of Ottawa 3
2012First Recorded Clinical Trial
15 TrialsResearching Breast Cancer
48 CompletedClinical Trials

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
525 Previous Clinical Trials
2,510,231 Total Patients Enrolled
31 Trials studying Breast Cancer
3,924 Patients Enrolled for Breast Cancer
Mark Clemons, MDPrincipal InvestigatorThe Ottawa Hospital Research Institute
10 Previous Clinical Trials
1,944 Total Patients Enrolled
4 Trials studying Breast Cancer
559 Patients Enrolled for Breast Cancer
John Hilton, MDPrincipal InvestigatorThe Ottawa Hospital Research Institute

Eligibility Criteria

Age 18+ · Female Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.