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AzTrials

Breast CancerPhase 4NCT05365230

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

A Phase 4 study testing On-demand personalized follow-up care in people with Breast Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
On-demand personalized follow-up care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
261 participants
Where
1 siteCanada
Study dates
19 Aug 2022to 15 Aug 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H8M2

Other trials in Canada

About this study

Official title: A Randomized Trial Evaluating Personalized vs Guideline-based Well Follow-up Strategies for Patients With Early-stage Breast Cancer (REaCT-Wellness)

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.

Read the detailed 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.

Conditions
Breast Cancer
Being tested
On-demand personalized follow-up care, Guideline-based follow-up care (standard of care)
Keywords
Well Follow-up, Follow-up Interval
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

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

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

Study groups in NCT05365230
Study groupRoleWhat they receive
On-demand personalized follow-up careActive comparatorOn-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.
Receives: Other: On-demand personalized follow-up care
Guideline-based follow-up careActive comparatorGuideline-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.
Receives: Other: Guideline-based follow-up care (standard of care)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months after randomization

Secondary outcomes (6)

  1. Fear of recurrence

    Fear of recurrence will be measured by the Functional Assessment of Cancer Therapy - Fear of Recurrence (FACT-FRQ) questionnaire. It consists of 3 questions suggested by David Cella at FACIT (Functional Assessment of Chronic Illness Therapy), that were adapted from Vickberg's Concerns about Recurrence (CARS) questionnaire.

    Measured: 24 months after randomization

  2. Anxiety levels

    Anxiety levels as determined by the Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS questionnaire measures anxiety and depression, which commonly coexist. It is comprised of seven questions for anxiety and seven questions for depression.

    Measured: 24 months after randomization

  3. Treatment related toxicity concerns

    Treatment related toxicity concerns as assessed using the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire. The FACT-ES questionnaire is a validated sub scale of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. FACT-ES consists of 46 items on a 5 point Likert type scale ranging from 0 (not at all) to 4 (very much). It is designed to measure five domains of health: physical well-being, social/family well-being, emotional well-being, functional well being and endocrine symptom subscale.

    Measured: 24 months after randomization

  4. Recurrence-free survival

    Measured by the number of participants free of breast cancer recurrence after 24 months of follow-up.

    Measured: 24 months after randomization

  5. Patient visits

    Number of patient reported visits to different healthcare providers using a Patient Follow-up Questionnaire. The follow-up questionnaire consists of questions that assess the number of follow up visits a participant has had and also the type of healthcare provider the follow-up visits were with.

    Measured: 24 months after randomization

  6. Cost-effectiveness

    Incremental cost-effectiveness rations (cost per one quality-adjusted life year (QALY) gained.

    Measured: 24 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2022
  2. Study start19 Aug 2022
  3. Primary completion14 Apr 2025
  4. Study completion15 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05365230
Sponsor's protocol ID
REaCT-Wellness
Status last verified
Jul 2026
First submitted
4 May 2022
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36922304

  • 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.

    PubMed 38194133

  • 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.

    PubMed 40014172

  • 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.

    PubMed 38320146

  • 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.

    PubMed 33813329

  • Beltran-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.

    PubMed 42041743

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing On-demand personalized follow-up care in people with Breast Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-Related Quality of Life (time frame: 24 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05365230, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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