Personalized vs Standard Follow-Up Care for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byJohn Hilton, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Ottawa Hospital Research Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

John Hilton, MD

Principal Investigator

The Ottawa Hospital Research Institute

Mark Clemons, MD

Principal Investigator

The Ottawa Hospital Research Institute

Eligibility Criteria

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.

Inclusion Criteria

I am referred to the WBCP after finishing my initial breast cancer treatment.

Exclusion Criteria

I have had breast cancer before, whether it came back or spread.

I am currently taking zoledronate, LHRH, or abemaciclib.

Treatment Details

Interventions

Guideline-based follow-up care (standard of care) (Behavioural Intervention)
On-demand personalized follow-up care (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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.