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

NCT ID: NCT05609435

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-16
• Study Completion Date: 2026-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

REASSURE Follow Up care

Group Type: EXPERIMENTAL

REASSURE

Intervention Type: OTHER

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.

Usual Follow Up Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of stage I, ER and/or PR positive, her2neu negative breast cancer within the last 6-24 monoths
• Willing to complete study procedures using email

Exclusion Criteria

• Receipt of chemotherapy for the stage I ER and/or PR positive, her2neu negative breast cancer diagnosed within the last 6-24 months
• Participants will be excluded if they are unable to read and write in English or if, in the opinion of a treating clinician, have cognitive impairment that would prevent completion of study procedures
• Pregnancy, based on patient self-report. If a patient becomes pregnant during the study period, they will be removed from the study at that time.
• Diagnosis of a ER and PR negative, her2neu negative breast cancer or a her2neu positive breast cancer within the last 5 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Neuman

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

UW Health Oncology Clinics

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

SMPH/SURGERY/SURG ONC

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 1/18/2024

Identifier Type: OTHER

Identifier Source: secondary_id

UW22095

Identifier Type: -

Identifier Source: org_study_id