Personalized vs Standard Follow-Up Care for Breast Cancer

Overseen By Emma Himmelman

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Zoledronate, LHRH, Abemaciclib

Disqualifiers: Prior invasive, recurrent, metastatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

264 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently receiving zoledronate, LHRH, or abemaciclib.

What data supports the effectiveness of personalized follow-up care for breast cancer?

Research suggests that personalized follow-up care, which tailors the number of visits based on individual risk, is feasible and acceptable for breast cancer patients. It can reduce the number of visits for low-risk patients without affecting patient satisfaction, anxiety, or recurrence rates, potentially lowering healthcare costs and patient burden. ^{1 2 3 4 5}

Is personalized follow-up care for breast cancer safe?

Research shows that personalized follow-up care, such as nurse-led follow-up on demand, is safe for breast cancer patients. Studies found no significant differences in patient safety, anxiety, or satisfaction compared to traditional physician-led follow-up. ^{1 6 7 8 9}

How does personalized follow-up care for breast cancer differ from standard follow-up care?

Personalized follow-up care for breast cancer is unique because it tailors the follow-up process to the individual needs of each patient, considering their specific health conditions and resources, unlike the standard one-size-fits-all approach. This method aims to improve patient satisfaction and optimize healthcare resources by providing more efficient and cost-effective care. ^{2 3 4 10 11}

Research Team

John Hilton, MD

Principal Investigator

The Ottawa Hospital Research Institute

Mark Clemons, MD

Principal Investigator

The Ottawa Hospital Research Institute

Eligibility Criteria

This trial is for individuals who have completed initial treatment for early-stage breast cancer and are being referred to the Wellness Beyond Cancer Program. It's not open to those with a history of invasive or recurrent breast cancer, metastatic disease, or patients currently on specific medications like zoledronate.

Inclusion Criteria

I am referred to the WBCP after finishing my initial breast cancer treatment.

Exclusion Criteria

I have had breast cancer before, whether it came back or spread.

I am currently taking zoledronate, LHRH, or abemaciclib.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Treatment

Participants complete the acute phase of their treatment, including surgery, chemotherapy, and/or radiation therapy

Varies

Follow-up

Participants are routinely followed in clinic every 3-6 months for several years to monitor health-related quality of life and other outcomes

24 months

Every 3-6 months

Personalized Follow-up

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

24 months

Treatment Details

Interventions

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

Trial Overview The study compares two types of follow-up care after breast cancer treatment: personalized follow-up as needed versus regular check-ups based on established guidelines. The goal is to determine which strategy is more effective for early-stage breast cancer survivors.

Participant Groups

Group I: Guideline-based follow-up care Active Control 1 Intervention

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.

Group II: On-demand personalized follow-up care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of tailored follow-up for patients with early breast cancer. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Opportunities for personalised follow-up care among patients with breast cancer: A scoping review to identify preference-sensitive decisions. [2022]

3. Scotland pubmed.ncbi.nlm.nih.gov

Evaluation of the adherence to follow-up care guidelines for women with breast cancer. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Periodic follow-up after breast cancer and the effect on survival. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Personalized surveillance and aftercare for non-metastasized breast cancer: the NABOR study protocol of a multiple interrupted time series design. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Use of Routine Health Datasets to Assess the Appropriateness of Diagnostic Tests in the Follow-Up of Breast Cancer Patients: A Population-Based Study on 3930 Patients. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Adherence to quality breast cancer survivorship care in four Canadian provinces: a CanIMPACT retrospective cohort study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Patient satisfaction with nurse-led telephone follow-up after curative treatment for breast cancer. [2021]

9. Scotland pubmed.ncbi.nlm.nih.gov

Nurse-led follow-up on demand or by a physician after breast cancer surgery: a randomised study. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Implementing personalized pathways for cancer follow-up care in the United States: Proceedings from an American Cancer Society-American Society of Clinical Oncology summit. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Patient demographic and tumor characteristics influencing oncologist follow-up frequency in older breast cancer survivors. [2022]