Clinical trial NCT05365230: A Randomized Trial Evaluating Personalized vs Guideline-based Well Follow-up Strategies for Patients With Early-stage Breast Cancer
Official title: A Randomized Trial Evaluating Personalized vs Guideline-based Well Follow-up Strategies for Patients With Early-stage Breast Cancer (REaCT-Wellness)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Well Follow-up
Follow-up Interval
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 264
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health-Related Quality of Life
timeFrame: 24 months after randomization
Secondary outcomes:
measure: Fear of recurrence
timeFrame: 24 months after randomization
measure: Anxiety levels
timeFrame: 24 months after randomization
measure: Treatment related toxicity concerns
timeFrame: 24 months after randomization
measure: Recurrence-free survival
timeFrame: 24 months after randomization
measure: Patient visits
timeFrame: 24 months after randomization
measure: Cost-effectiveness
timeFrame: 24 months after randomization
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
affiliation: The Ottawa Hospital Research Institute
name: Mark Clemons, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ottawa Hospital Research Institute
name: John Hilton, MD
role: PRINCIPAL_INVESTIGATOR
References: