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

Study Overview
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Brief Summary
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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. 100 participants will be on study for up to 18 months.

Detailed Description
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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.

Official Title
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Evaluating a Novel Follow-up Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer Survivors in Wisconsin

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: REASSURE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized, trial of REASSURE vs usual care within UW Health oncology clinics
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REASSURE Follow Up care<br> | Other: REASSURE<br>* 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.<br>|
| No Intervention: Usual Follow Up Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants In Intervention Arm who would recommend this approach to follow-up to other survivors | REASSURE will be considered acceptable if ≥80% of survivors in the REASSURE arm respond yes to, Would you recommend this approach to follow-up to other survivors?. | up to 18 months | 
| Number of Threshold-Level Symptoms Reported on the PRO Assessment | The number of threshold-level symptoms reported on the Patient Reported Outcome (PRO) assessment at each follow-up time point will be reported. This is based on the investigators' previously established thresholds of symptoms or concerns that warrant a visit. Some symptoms were hard stops, meaning any reported symptom triggered a visit, other symptoms triggered a visit based on severity or level of interference. | 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 | The number of follow-up visits over the 18-month follow-up period will be counted. All follow-up visits that occur in medical oncology, radiation oncology, surgery, and survivorship clinics, including both physician and advanced practice provider visits will be counted. | up to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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follow up care, low risk, health care delivery