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Personalized vs Standard Follow-Up Care for Breast Cancer

Phase 4
Waitlist Available
Led By John Hilton, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months after randomization
Awards & highlights

Study Summary

This trial will compare two follow-up schedules for breast cancer patients - one based on guidelines and the other personalized.

Who is the study for?
This trial is for individuals who have completed initial treatment for early-stage breast cancer and are being referred to the Wellness Beyond Cancer Program. It's not open to those with a history of invasive or recurrent breast cancer, metastatic disease, or patients currently on specific medications like zoledronate.Check my eligibility
What is being tested?
The study compares two types of follow-up care after breast cancer treatment: personalized follow-up as needed versus regular check-ups based on established guidelines. The goal is to determine which strategy is more effective for early-stage breast cancer survivors.See study design
What are the potential side effects?
Since this trial focuses on follow-up strategies rather than direct medical treatments, there are no typical medication side effects involved. However, different follow-up schedules may impact quality of life and anxiety levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Health-Related Quality of Life
Secondary outcome measures
Anxiety levels
Cost-effectiveness
Fear of recurrence
+3 more

Trial Design

2Treatment groups
Active Control
Group I: Guideline-based follow-up careActive Control1 Intervention
Guideline-based follow-up care (i.e. current standard of care). Both groups will have yearly mammograms (current standard of care) organized by their healthcare provider.
Group II: On-demand personalized follow-up careActive Control1 Intervention
On-demand personalized follow-up care (on-demand access to a Wellness Beyond Cancer Program (WBCP) nurse and an annual follow-up by telephone with WBCP nurse following the patient's annual mammogram). Both groups of participants will have yearly mammograms (current standard of care) organized by their healthcare provider.

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
564 Previous Clinical Trials
2,787,603 Total Patients Enrolled
34 Trials studying Breast Cancer
4,997 Patients Enrolled for Breast Cancer
John Hilton, MDPrincipal InvestigatorThe Ottawa Hospital Research Institute
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

Media Library

Guideline-based follow-up care (standard of care) Clinical Trial Eligibility Overview. Trial Name: NCT05365230 — Phase 4
Breast Cancer Research Study Groups: Guideline-based follow-up care, On-demand personalized follow-up care
Breast Cancer Clinical Trial 2023: Guideline-based follow-up care (standard of care) Highlights & Side Effects. Trial Name: NCT05365230 — Phase 4
Guideline-based follow-up care (standard of care) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05365230 — Phase 4
~138 spots leftby Jul 2026