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

Phase 4

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Other: On-demand personalized follow-up care; Other: Guideline-based follow-up care (standard of care)

• Registration Number: NCT05365230
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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. 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

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.

Study Timeline

• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Study Start: 2022-08-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 264

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
On-demand personalized follow-up care	On-demand personalized follow-up care	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.
Guideline-based follow-up care	Guideline-based follow-up care (standard of care)	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.

Primary Outcome Measures

Name	Time	Method
Health-Related Quality of Life	24 months after randomization	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.

Secondary Outcome Measures

Name	Time	Method
Fear of recurrence	24 months after randomization	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.
Anxiety levels	24 months after randomization	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.
Treatment related toxicity concerns	24 months after randomization	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.
Recurrence-free survival	24 months after randomization	Measured by the number of participants free of breast cancer recurrence after 24 months of follow-up.
Cost-effectiveness	24 months after randomization	Incremental cost-effectiveness rations (cost per one quality-adjusted life year (QALY) gained.
Patient visits	24 months after randomization	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.

Trial Locations

Locations (1)

The Ottawa Hospital Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada