Clinical trial · Interventional
A Randomized Trial Evaluating Personalized vs Guideline-based Well Follow-up Strategies for Patients With Early-stage Breast Cancer
A Randomized Trial Evaluating Personalized vs Guideline-based Well Follow-up Strategies for Patients With Early-stage Breast Cancer (REaCT-Wellness)
NCT05365230CI-TRIAL-00117318completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Guideline-based follow-up care (standard of care) | Other | — | UNRESOLVED |
| On-demand personalized follow-up care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- On-demand personalized follow-up care
- description
- 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.
- interventionNames
- Other: On-demand personalized follow-up care
- type
- ACTIVE_COMPARATOR
- label
- Guideline-based follow-up care
- description
- 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.
- interventionNames
- Other: Guideline-based follow-up care (standard of care)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Being referred to the Wellness Beyond Cancer Program (WBCP) for routine follow-up after completion of acute phase of treatment for invasive breast cancer Exclusion Criteria: * History of prior invasive breast cancer, recurrent brest cancer or metastatic breast cancer * Currently receiving zoledronate, LHRH (Gonadotropin-releasing hormone) or abemaciclib
References
Publications (6)
- BACKGROUNDBeltran-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 36922304
- BACKGROUNDBeltran-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 38194133
- BACKGROUNDBeltran-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 40014172
- BACKGROUNDBeltran-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 38320146
- BACKGROUNDSurujballi 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 33813329
- RESULTBeltran-Bless AA, Himmelman E, Kim A, Pond GR, Fallah P, Ng T, Hilton J, Savard MF, Larocque G, Baines KA, Primeau K, Saunders D, Allard D, Vandermeer L, Clemons M. A Randomized Trial Evaluating Personalized Versus Guideline-Based Well Follow-Up Strategies for Patients with Early Breast Cancer: Feasibility Outcomes. Curr Oncol. 2026 Apr 17;33(4):224. doi: 10.3390/curroncol33040224.