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

University of Wisconsin (UW)

Status

Active, not recruiting

Conditions

Breast Cancer

Treatments

Other: REASSURE

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05609435

SMPH/SURGERY/SURG ONC (Other Identifier)

UW22095

Protocol Version 1/18/2024 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

104 patients

Sex

Female

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

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