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A Randomized Trial Evaluating Personalized vs Guideline-based Well Follow-up Strategies for Patients With Early-stage Breast Cancer

NCT05365230 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2026-04-07

No results posted yet for this 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.

Conditions

Interventions

OTHER

On-demand personalized follow-up care

On-demand personalized follow-up care (on demand access to a WBCP nurse and an annual follow-up by telephone.

OTHER

Guideline-based follow-up care (standard of care)

Follow-up care based on current standard of care guidelines.

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Mark Clemons, MD · The Ottawa Hospital Research Institute

  • John Hilton, MD · The Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-19
Primary Completion
2025-04-14
Completion
2025-08-15

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05365230 on ClinicalTrials.gov