Remote Electronic Assessment of Survivors With Feedback Communication and Directed Referrals

NCT05047575 | Completed

• 4 other identifiers: UW21062Protocol Version 12/7/2021A5397132021-0961
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

low risk breast cancer; survivor; follow up care

Outcome Measures

Primary Outcomes (4)

• Feasibility: Number of Eligible Participants Enrolled

  The investigator's goal is a 50% recruitment rate of eligible patients

  up to 6 months

• Number of survivorship symptoms/concerns that were addressed during the follow-up visit following clinician review of the REASSURE PRO assessment

  The investigator's will summarize the number of domains where survivors reported symptoms/concerns and compare that to the number of domains that were addressed, either by the PRO generated recommendation or during the follow-up visit.

  up to 9 months

• Number of Participants who Replace or are Eligible to Replace a Medical Oncology Follow-Up visit with Feedback Communication

  The investigator's goal is to have 33% of REASSURE cohort 1 replace a follow-up visit with medical oncology with feedback communication and REASSURE cohort 2 to be eligible to replace a follow-up visit (if the full intervention had been implemented).

  up to 1 year

• Number of PRO-generated Referral Recommendations that are Concordant with Medical Oncology Opinion

  The investigator's goal is to have 75% of referral recommendations be concordant with medical oncology opinion.

  up to 6 months

Secondary Outcomes (5)

• Percent of Survivors Who Would Recommend this Approach to other survivors

  up to 9 months

• Number of Participants Whose Concerns Were Addressed During the Preceding Visit

  up to 6 months

• Satisfaction with survivorship information measured with the Satisfaction with Information and Care Scale

  up to 6 months

• Knowledge about survivorship issues measured with the Preparing for Life as a (New) Survivor (PLANS) Scale

  up to 6 months

• Preparedness for survivorship issues measured with the Preparing for Life as a (New) Survivor (PLANS) Scale

  up to 6 months

Other Outcomes (2)

• The Human Connection (THC) Scale Score

  up to 9 months

• Impact of Event Scale Score

  up to 9 months

Study Arms (2)

REASSURE Cohort 1

EXPERIMENTAL

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).

Other: REASSURE

REASSURE Cohort 2

EXPERIMENTAL

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).

Other: REASSURE

Interventions

REASSURE 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.

Also known as: Remote Electronic Assessment of Survivors with Feedback Communication and Directed Referrals

REASSURE Cohort 1; REASSURE Cohort 2

Eligibility Criteria

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

You may qualify if:

• history of stage I, ER and/or PR positive, her2neu negative breast cancer
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

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, MD, MS, FACS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 17, 2021
• Study Start: August 24, 2021
• Primary Completion: July 28, 2022
• Study Completion: July 28, 2022
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)