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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: On-demand personalized follow-up care
* Other: Guideline-based follow-up care (standard of care)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: On-demand personalized follow-up care<br>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<br>* On-demand personalized follow-up care (on demand access to a WBCP nurse and an annual follow-up by telephone.<br>|
| Active Comparator: Guideline-based follow-up care<br>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)<br>* Follow-up care based on current standard of care guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months after randomization | 
| 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. | 24 months after randomization | 
| 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. | 24 months after randomization | 
| Recurrence-free survival | Measured by the number of participants free of breast cancer recurrence after 24 months of follow-up. | 24 months after randomization | 
| 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. | 24 months after randomization | 
| Cost-effectiveness | Incremental cost-effectiveness rations (cost per one quality-adjusted life year (QALY) gained. | 24 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Well Follow-up, Follow-up Interval