Personalized vs Standard Follow-Up Care for Breast Cancer

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Overseen ByEmma Himmelman
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: Ottawa Hospital Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to monitor breast cancer survivors after their initial treatment ends. Researchers aim to determine if personalized follow-up care, where patients have on-demand access to a nurse, is more effective than the usual scheduled check-ups (guideline-based follow-up care). Both groups will continue to receive yearly mammograms. This trial targets individuals who have completed their main breast cancer treatments and are beginning routine follow-up care. Those with a history of invasive breast cancer or who are on certain medications might not be eligible. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand how it benefits more patients.

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 is the safety track record for these follow-up care treatments?

Research has shown that personalized follow-up care, available as needed after breast cancer treatment, is safe and well-received. In one study, patients who received nurse-led follow-up care reported positive experiences without major problems. Another program, the Wellness Beyond Cancer Program, found that patients valued having a nurse available for support, with no serious side effects reported. This approach helps patients feel more in control and supported during recovery. Overall, this personalized care model is considered safe and provides a comforting experience for breast cancer survivors.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores a new way to support breast cancer survivors through personalized follow-up care. Unlike the standard guideline-based follow-up, which involves routine check-ins and yearly mammograms, the on-demand personalized care offers patients direct access to a Wellness Beyond Cancer Program nurse whenever they need it. This approach tailors care to individual needs, potentially improving patient satisfaction and outcomes by allowing more flexible and responsive support. By comparing these two methods, researchers hope to find out if personalized follow-up care can enhance the recovery journey and quality of life for breast cancer survivors.

What evidence suggests that this trial's follow-up care strategies could be effective for breast cancer patients?

This trial will compare personalized follow-up care with standard follow-up care for breast cancer survivors. Research has shown that personalized follow-up care can enhance the well-being of these survivors. Participants in the on-demand personalized follow-up care arm will have access to a nurse, which studies have found often leads to greater satisfaction and a better quality of life compared to standard care. A special tool has been created to customize this care, ensuring patients receive the right support. Access to a nurse for follow-up when needed proves just as effective, if not better, than traditional follow-up with a doctor. This method provides patients with more control and flexibility, which can aid their overall recovery and mental health.678910

Who Is on the Research Team?

Dr. John Hilton – REAL ALLIANCE

John Hilton, MD

Principal Investigator

The Ottawa Hospital Research Institute

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Mark Clemons, MD

Principal Investigator

The Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Guideline-based follow-up careActive Control1 Intervention
Group II: On-demand personalized follow-up careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials
585
Recruited
3,283,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38695938/
The effectiveness of personalised surveillance and ...A systematic review was performed to get insight in existing evidence on (cost-)effectiveness of personalised follow-up.
Personalized surveillance and aftercare for non-metastasized ...Patient reported outcomes will be measured at five points in time during two years of follow-up care (starting about one year after treatment ...
Development of a personalized follow-up care algorithm for ...The objective of this study was to test a clinical prediction algorithm to distinguish low-complexity breast cancer survivors who may be suited to self-manage ...
Nurse-led follow-up on demand or by a physician after ...The aim of this study was to compare nurse-led follow-up on demand versus physician follow-up after breast cancer treatment with regards to patients' well-being ...
A Randomized Trial Evaluating Personalized vs Guideline ...A Randomized Trial Evaluating Personalized vs Guideline-based Well Follow-up Strategies for Patients With Early-stage Breast Cancer · Timeline.
The effectiveness of personalised surveillance and ...Breast cancer follow-up (surveillance and aftercare) varies from one-size-fits-all to more personalised approaches. A systematic review was performed to get ...
Wellness Beyond Cancer Program: building an effective ...Topics include understanding the coordination of care beyond cancer treatment, the roles of health professionals in survivor care, signs of cancer return for ...
a randomised study. Eur J Oncol Nurs 8: 109-117The aim of this study was to compare nurse-led follow-up on demand versus physician follow-up after breast cancer treatment with regards to ...
'Beyond Cancer' Rehabilitation Program to Support Breast ...Our team designed 'Beyond Cancer', a multimodal rehabilitation program to support breast cancer survivors to return to work.
Preparing breast cancer patients for survivorship (PREP)The process of breast cancer follow-up has psychosocial benefits for patients, notably reassurance, although attending hospital appointments can increase ...
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