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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05365230
• Other study ID #: REaCT-Wellness
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 19, 2022
• Est. completion date: July 2026

Study information

• Verified date: April 2023
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 264
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• On-demand personalized follow-up care
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)
Follow-up care based on current standard of care guidelines.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

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