NCT05365230

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for phase_4 breast-cancer

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 19, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

2.7 years

First QC Date

May 4, 2022

Last Update Submit

November 21, 2025

Conditions

Breast Cancer

Keywords

Well Follow-upFollow-up Interval

Outcome Measures

Primary Outcomes (1)

  • Health-Related Quality of Life

    Health-Related Quality of Life as determined by the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. The FACT-G is a 27-item questionnaire designed to measure four domains of Health related quality of life (HRQOL) in cancer patients: physical, social, emotional and functional well-being.

    24 months after randomization

Secondary Outcomes (6)

  • Fear of recurrence

    24 months after randomization

  • Anxiety levels

    24 months after randomization

  • Treatment related toxicity concerns

    24 months after randomization

  • Recurrence-free survival

    24 months after randomization

  • Patient visits

    24 months after randomization

  • +1 more secondary outcomes

Study Arms (2)

On-demand personalized follow-up care

ACTIVE COMPARATOR

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.

Other: On-demand personalized follow-up care

Guideline-based follow-up care

ACTIVE COMPARATOR

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.

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

Interventions

On-demand personalized follow-up careOTHER

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

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

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

Guideline-based follow-up care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • History of prior invasive breast cancer, recurrent brest cancer or metastatic breast cancer
  • Currently receiving zoledronate, LHRH (Gonadotropin-releasing hormone) or abemaciclib

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H8M2, Canada

Location

Related Publications (5)

  • Beltran-Bless AA, Alshamsan B, Alzahrani MJ, Hilton J, Baines KA, Samuel V, Pond GR, Vandermeer L, Clemons M, Larocque G. Regularly scheduled physical examinations and the detection of breast cancer recurrences. Breast. 2023 Jun;69:274-280. doi: 10.1016/j.breast.2023.03.004. Epub 2023 Mar 8.

    PMID: 36922304BACKGROUND

  • Beltran-Bless AA, Larocque G, Brackstone M, Arnaout A, Caudrelier JM, Boone D, Fallah P, Ng T, Cross P, Alqahtani N, Hilton J, Vandermeer L, Pond G, Clemons M. The COVID-19 pandemic and its effects on follow-up of patients with early breast cancer: A patient survey. Breast Cancer Res Treat. 2024 Apr;204(3):531-538. doi: 10.1007/s10549-023-07232-3. Epub 2024 Jan 9.

    PMID: 38194133BACKGROUND

  • Beltran-Bless AA, Larocque G, Arnaout A, Caudrelier JM, Hilton J, Alqahtani N, Vandermeer L, Pond G, Clemons M. Evolving strategies for the routine follow-up of patients with early breast cancer and the impact of COVID-19: a survey of healthcare providers. Support Care Cancer. 2025 Feb 27;33(3):232. doi: 10.1007/s00520-025-09205-2.

    PMID: 40014172BACKGROUND

  • Beltran-Bless AA, Clemons M. How Frequently Should Patients with Breast Cancer Have Routine Follow-Up Visits? NEJM Evid. 2023 Aug;2(8):EVIDtt2300062. doi: 10.1056/EVIDtt2300062. Epub 2023 Jul 25.

    PMID: 38320146BACKGROUND

  • Surujballi J, Shah H, Hutton B, Alzahrani M, Beltran-Bless AA, Shorr R, Larocque G, McGee S, Cole K, Ibrahim MFK, Fernandes R, Arnaout A, Stober C, Liu M, Sienkiewicz M, Saunders D, Vandermeer L, Clemons M. The COVID-19 pandemic: An opportunity to rethink and harmonise the frequency of follow-up visits for patients with early stage breast cancer. Cancer Treat Rev. 2021 Jun;97:102188. doi: 10.1016/j.ctrv.2021.102188. Epub 2021 Mar 23.

    PMID: 33813329BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Mark Clemons, MD

    The Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

  • John Hilton, MD

    The Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 9, 2022

Study Start

August 19, 2022

Primary Completion

April 14, 2025

Study Completion

August 15, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Locations

CA(1)