Remote Electronic Assessment of Survivors With Feedback Communication and Directed Referrals

NCT ID: NCT05047575

Last Updated: 2022-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-24
• Study Completion Date: 2022-07-28

Brief Summary

This study tests a novel, risk-stratified approach for low risk breast cancer survivor follow-up care that reduces burden for survivors and their oncologists while simultaneously delivering more comprehensive care. The intervention is called Remote Electronic Assessment of Survivors with Feedback Communication and Directed Referrals (REASSURE). 50 participants will be enrolled into 2 cohorts, 25 into cohort 1 who will experience the REASSURE intervention 6 months from enrollment and 25 into cohort 2 who will experience components of the REASSURE intervention at their next follow-up visit. Participants can expect to be on study for up to 9 months.

Detailed Description

Current follow-up care for 3 million+ breast cancer survivors is both burdensome and fails to comprehensively address survivors' needs. Survivors and oncologists value these visits because visits reassure survivors about recurrence, and support oncologists' views about their responsibilities for managing ongoing therapy. However, early-stage survivors derive less benefit from follow-up, while incurring substantial financial burdens. Further, follow-up visit time restraints prevent addressing all topics prioritized by survivors or recommended as comprehensive survivorship care. Because most low-risk breast cancer survivors will never experience a recurrence, there is a critical need to develop a novel, risk-stratified approach to follow-up that reduces burden for survivors and their oncologists while simultaneously delivering more comprehensive care.

To address this gap, the team engaged stakeholders to develop an intervention for low-risk breast cancer survivors, called Remote Electronic Assessment of Survivors with Feedback Communication and Directed Referrals (REASSURE). REASSURE maintains one annual in-person oncology visit, consistent with stakeholder preferences for oncology-based follow-up. REASSURE utilizes remote patient-reported outcomes assessments to comprehensively assess symptoms, promotes practice change by providing feedback reports to oncologists and engaging primary care providers (PCPs) in survivorship care, and reduces the burden of follow-up by substituting an oncology visit for thriving survivors with reassurance messaging and encouragement to pursue preventive care. The investigators have successfully pilot tested the PRO assessment and estimate that 25% of low-risk breast cancer survivors will have symptoms requiring a follow-up visit with medical oncology.

In this pilot feasibility study, the REASSURE intervention will be implemented into clinical care for the first time. Eligible survivors will be recruited and use mixed methods to accomplish four study objectives:

• Objective 1. Assess the feasibility of implementing REASSURE into clinical practice.
• Objective 2. Determine the number of survivorship symptoms/concerns that were addressed during the follow-up visit following clinician review of the REASSURE PRO assessment.
• Objective 3. Characterize the impact of REASSURE on healthcare utilization.
• Objective 4. Assess concordance between the referral recommendation generated from the PRO assessment and medical oncologist opinion.

Conditions

Breast Cancer

Study Design

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

Study Groups

REASSURE Cohort 1

Survivors who are enrolled at time of a follow-up visit and who will be offered the REASSURE intervention at the next 6 month visit (including the opportunity to replace a visit with feedback communication).

Group Type: EXPERIMENTAL

REASSURE

Intervention Type: OTHER

REASSURE utilizes remote patient-reported outcomes assessments to comprehensively assess symptoms, promotes practice change by providing feedback reports to oncologists and engaging primary care providers (PCPs) in survivorship care, and reduces the burden of follow-up by substituting an oncology visit for thriving survivors with reassurance messaging and encouragement to pursue preventive care.

REASSURE Cohort 2

Survivors who are enrolled prior to a follow-up visit and who will be offered the REASSURE PRO assessment and feedback communication (but not provided the opportunity to replace a visit with feedback communication).

Group Type: EXPERIMENTAL

REASSURE

Intervention Type: OTHER

REASSURE utilizes remote patient-reported outcomes assessments to comprehensively assess symptoms, promotes practice change by providing feedback reports to oncologists and engaging primary care providers (PCPs) in survivorship care, and reduces the burden of follow-up by substituting an oncology visit for thriving survivors with reassurance messaging and encouragement to pursue preventive care.

Interventions

REASSURE

REASSURE utilizes remote patient-reported outcomes assessments to comprehensively assess symptoms, promotes practice change by providing feedback reports to oncologists and engaging primary care providers (PCPs) in survivorship care, and reduces the burden of follow-up by substituting an oncology visit for thriving survivors with reassurance messaging and encouragement to pursue preventive care.

Intervention Type: OTHER

Other Intervention Names

Remote Electronic Assessment of Survivors with Feedback Communication and Directed Referrals

Eligibility Criteria

Inclusion Criteria

• history of stage I, ER and/or PR positive, her2neu negative breast cancer
• 12-36 months from diagnosis at the time of the survey assessment (for both REASSURE cohorts 1 and 2). For REASSURE cohort 1, this will translate into being 6-18 months from diagnosis at the time they are approached for the study.
• receiving follow-up for their breast cancer with a University of Wisconsin (UW) Breast Center medical oncologist participating in the REASSURE pilot study
• ability to complete the PRO assessment online
• English speaker

Exclusion Criteria

• receipt of chemotherapy
• non-English speakers
• pregnancy
• cancer recurrence (local, regional or distant) since the initial diagnosis

• 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, MD, MS, FACS

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

Protocol Version 12/7/2021

Identifier Type: OTHER

Identifier Source: secondary_id

A539713

Identifier Type: OTHER

Identifier Source: secondary_id

2021-0961

Identifier Type: OTHER

Identifier Source: secondary_id

UW21062

Identifier Type: -

Identifier Source: org_study_id