Remote Electronic Assessment of Survivors With Feedback Communication and Directed Referrals

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of a Follow-up Intervention to Improve the Quality of Care for Low-Risk Breast Cancer Survivors

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: 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

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REASSURE Cohort 1<br>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<br>* 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.<br>* Other names: Remote Electronic Assessment of Survivors with Feedback Communication and Directed Referrals;|
| Experimental: REASSURE Cohort 2<br>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<br>* 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.<br>* Other names: Remote Electronic Assessment of Survivors with Feedback Communication and Directed Referrals;|

What is the study measuring?
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Primary Outcome Measures

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Survivors Who Would Recommend this Approach to other survivors | Participants will be asked to answer yes or no to the following question: Would you recommend this approach to follow-up 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 | Scored on a 5 point likert scale where 1 = very dissatisfied; 2 = dissatisfied; 3 = neutral; 4 = satisfied; 5 = very satisfied. Higher scores indicated increased satisfaction, mean score between 1-5 will be reported. | up to 6 months | 
| Knowledge about survivorship issues measured with the Preparing for Life as a (New) Survivor (PLANS) Scale | This is an 11 item scale, measured on a 4-point Likert scale from 0 to 3 where lower scores indicate more knowledge. Mean score between 0-3 will be reported. | up to 6 months | 
| Preparedness for survivorship issues measured with the Preparing for Life as a (New) Survivor (PLANS) Scale | This is a 5 item scale, measured on a 10-point Likert scale where higher scores indicate increased preparedness. Mean score between 1-10 will be reported. | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low risk breast cancer, survivor, follow up care