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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months after randomization
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 moreTrial 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.
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Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,427 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had breast cancer before, whether it came back or spread.I am currently taking zoledronate, LHRH, or abemaciclib.I am referred to the WBCP after finishing my initial breast cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Guideline-based follow-up care
- Group 2: On-demand personalized follow-up care
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial still have open slots for participants?
"Indeed, the information provided on clinicaltrials.gov verifies that enrollment for this trial is currently in progress. The recruitment effort was initiated on August 19th 2022 and has been revised as recently as September 13th of the same year. Currently, 228 patients are needed across one medical facility to participate in this research project."
Answered by AI
What is the estimated size of the population participating in this trial?
"Affirmative. Clinicaltrials.gov indicates that the trial, which was originally uploaded on August 19th 2022 and updated most recently September 13th 2022, is currently enrolling participants - 228 patients to be exact from a single medical centre."
Answered by AI
What are the associated risks of utilizing On-demand personalized follow-up care for patients?
"There is ample evidence that On-demand personalized follow-up care has been approved, thus earning it a score of 3."
Answered by AI
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