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

Last updated: July 9, 2025
Sponsor: Ottawa Hospital Research Institute
Overall Status: Active - Not Recruiting

Phase

4

Condition

Breast Cancer

Cancer

Treatment

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

On-demand personalized follow-up care

Clinical Study ID

NCT05365230
REaCT-Wellness
  • Ages > 18
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Being referred to the Wellness Beyond Cancer Program (WBCP) for routine follow-upafter completion of acute phase of treatment for invasive breast cancer

Exclusion

Exclusion Criteria:

  • History of prior invasive breast cancer, recurrent brest cancer or metastatic breastcancer

  • Currently receiving zoledronate, LHRH (Gonadotropin-releasing hormone) orabemaciclib

Study Design

Total Participants: 261
Treatment Group(s): 2
Primary Treatment: Guideline-based follow-up care (standard of care)
Phase: 4
Study Start date:
August 19, 2022
Estimated Completion Date:
August 31, 2025

Study Description

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. The frequency of follow-up varies between and within different institutions. To date, no de-escalation strategy has appropriately evaluated patient reported outcomes such as quality of life or perception of care. There has been a growing body of evidence that de-intensification of follow-up is safe, effective and reduces costs for both patients and the health care system. Therefore the investigators propose a randomized trial evaluating personalized vs guideline-based well follow-up strategies for patients with early-stage breast cancer.

Connect with a study center

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario K1H8M2
    Canada

    Site Not Available

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