NCT05609435

Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer

Evaluating a Novel Follow-up Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer Survivors in Wisconsin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

This study tests a novel intervention designed to optimize needed survivorship care for low-risk breast cancer survivors while reducing burdensome care with limited health benefits. This study examines whether the intervention, titled REASSURE, improves survivors' preparedness for survivorship. Up to 110 participants will be on study for up to 18 months.

Detailed description

The investigators plan a single site prospective, randomized, trial that will compare the effect of REASSURE on survivor preparedness against usual care. Survivors will be identified from breast oncology clinics within UW Health. REASSURE is comprised of three components: 1) the REASSURE PRO assessment, which assesses survivors' symptoms and/or concerns, 2) a recommendation for or against a follow-up visit based on survivors reported symptoms /concerns using pre-established thresholds, and 3) REASSURE survivorship messaging. * Primary Objective * Compare survivors' preparedness for survivorship with REASSURE versus usual care. * Secondary Objectives * Determine the acceptability of REASSURE for survivors living in rural and non-rural areas. * Assess changes in survivor reported symptoms and number of follow-up visits with REASSURE versus usual care.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	REASSURE	REASSURE is comprised of three components that are intended to be integrated into survivorship care at each follow-up visit: 1) An online patient-reported outcome (PRO) assessment to comprehensively evaluate survivors' symptoms and concerns; 2) A tailored follow-up recommendation based on pre-established thresholds for reported symptoms and concerns. Survivors who report symptoms or concerns have a follow-up visit to discuss findings whereas survivors without symptoms or concerns will avoid a follow-up visit; and 3) Online survivorship messaging sent after the visit, which includes reassurance about the low recurrence risk, an overview of what to expect from follow-up, and steps survivors can take to reduce cancer risk.

Timeline

• Start date: 2022-11-16
• Primary completion: 2026-01-27
• Completion: 2026-01-27
• First posted: 2022-11-08
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States