Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Other: REASSURE
- Registration Number
- NCT05609435
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
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. Up to 110 participants will be on study for up to 18 months.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 104
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description REASSURE Follow Up care REASSURE -
- Primary Outcome Measures
Name Time Method Preparing for Life as a (New) Survivor (PLANS) Scale Score: Part 1 up to 18 months 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.
Preparing for Life as a (New) Survivor (PLANS) Scale Score: Part 2 up to 18 months 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.
- Secondary Outcome Measures
Name Time Method Number of Threshold-Level Symptoms Reported on the PRO Assessment up to 18 months 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.
Number of Follow Up Visits up to 18 months 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.
Number of Participants In Intervention Arm who would recommend this approach to follow-up to other survivors up to 18 months 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?".
Number of Threshold-Level Symptoms Survivors Perceive are Addressed on each visit up to 18 months
Trial Locations
- Locations (1)
UW Health Oncology Clinics
🇺🇸Madison, Wisconsin, United States