Clinical trial NCT05047575: Remote Electronic Assessment of Survivors With Feedback Communication and Directed Referrals
Official title: Pilot Study of a Follow-up Intervention to Improve the Quality of Care for Low-Risk Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: low risk breast cancer
survivor
follow up care
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Feasibility: Number of Eligible Participants Enrolled
timeFrame: up to 6 months
measure: Number of survivorship symptoms/concerns that were addressed during the follow-up visit following clinician review of the REASSURE PRO assessment
timeFrame: up to 9 months
measure: Number of Participants who Replace or are Eligible to Replace a Medical Oncology Follow-Up visit with Feedback Communication
timeFrame: up to 1 year
measure: Number of PRO-generated Referral Recommendations that are Concordant with Medical Oncology Opinion
timeFrame: up to 6 months
Secondary outcomes:
measure: Percent of Survivors Who Would Recommend this Approach to other survivors
timeFrame: up to 9 months
measure: Number of Participants Whose Concerns Were Addressed During the Preceding Visit
timeFrame: up to 6 months
measure: Satisfaction with survivorship information measured with the Satisfaction with Information and Care Scale
timeFrame: up to 6 months
measure: Knowledge about survivorship issues measured with the Preparing for Life as a (New) Survivor (PLANS) Scale
timeFrame: up to 6 months
measure: Preparedness for survivorship issues measured with the Preparing for Life as a (New) Survivor (PLANS) Scale
timeFrame: up to 6 months
Other outcomes:
measure: The Human Connection (THC) Scale Score
timeFrame: up to 9 months
measure: Impact of Event Scale Score
timeFrame: up to 9 months
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Heather Neuman, MD, MS, FACS
role: PRINCIPAL_INVESTIGATOR
References: