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

NCT05609435 | Completed

• 5 other identifiers: 2022-1157SMPH/SURGERY/SURG ONCProtocol Version 1/18/2024UW22095NCI-2022-10267
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

follow up care; low risk; health care delivery

Outcome Measures

Primary Outcomes (2)

• Preparing for Life as a (New) Survivor (PLANS) Scale Score: Part 1

  Survivors' preparedness for survivorship will be assessed using Part 1 of the Preparing for Life as a (New) Survivor (PLANS) scale. This is an 11-item survey scored on a 4 point likert scale for a total possible range of score from 11 - 44 where higher scores indicate increased preparedness.

  up to 18 months

• Preparing for Life as a (New) Survivor (PLANS) Scale Score: Part 2

  Survivors' confidence about follow-up will be assessed using Part 2 of the Preparing for Life as a (New) Survivor (PLANS) scale. This is a 5-item survey scored on a 10 point likert scale for a total possible range of score from 5 - 50 where higher scores indicate increased confidence.

  up to 18 months

Secondary Outcomes (4)

• Number of Participants In Intervention Arm who would recommend this approach to follow-up to other survivors

  up to 18 months

• Number of Threshold-Level Symptoms Reported on the PRO Assessment

  up to 18 months

• Number of Threshold-Level Symptoms Survivors Perceive are Addressed on each visit

  up to 18 months

• Number of Follow Up Visits

  up to 18 months

Other Outcomes (7)

• Number of Participants Who Received Recommended Cancer Care

  up to 18 months

• Survivors' Experiences: Impact of Event Scale

  up to 18 months

• Survivors' Experiences: Satisfaction with Information

  up to 18 months

Study Arms (2)

REASSURE Follow Up care

EXPERIMENTAL

Other: REASSURE

Usual Follow Up Care

NO INTERVENTION

Interventions

REASSURE 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.

REASSURE Follow Up care

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW Health Oncology Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Heather Neuman

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, trial of REASSURE vs usual care within UW Health oncology clinics

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: November 16, 2022
• Primary Completion: January 27, 2026
• Study Completion: January 27, 2026
• Last Updated: April 14, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)