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REASSURE Program for Breast Cancer Follow-Up Care
N/A
Recruiting
Led By Heather Neuman
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights
Study Summary
This trial tests a new approach to care for low-risk breast cancer survivors, aiming to reduce unneeded care & improve their preparedness for survivorship. 100 participants followed for up to 18 months.
Who is the study for?
This trial is for low-risk breast cancer survivors who were diagnosed with stage I, ER and/or PR positive, her2neu negative breast cancer in the past 6-24 months. Participants must be able to use email and read/write in English without cognitive impairments. Pregnant individuals or those who received chemotherapy for their diagnosis are excluded.Check my eligibility
What is being tested?
The REASSURE intervention is being tested to see if it can improve preparedness for survivorship care among low-risk breast cancer survivors by optimizing necessary care while reducing unnecessary treatments. The study will involve 100 participants over an 18-month period.See study design
What are the potential side effects?
Since this trial focuses on follow-up care optimization rather than a medical treatment or drug, specific side effects are not detailed; however, any potential discomforts related to participation would likely stem from the logistics of following the intervention protocol.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Preparing for Life as a (New) Survivor (PLANS) Scale Score: Part 1
Preparing for Life as a (New) Survivor (PLANS) Scale Score: Part 2
Secondary outcome measures
Number of Follow Up Visits
Number of Participants In Intervention Arm who would recommend this approach to follow-up to other survivors
Number of Threshold-Level Symptoms Reported on the PRO Assessment
+1 moreOther outcome measures
Healthcare Utilization: Number of MyChart Visits and Phone Calls
Healthcare Utilization: Number of Visits and Services Used
Number of Participants Who Received Recommended Cancer Care
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: REASSURE Follow Up careExperimental Treatment1 Intervention
Group II: Usual Follow Up CareActive Control1 Intervention
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,436 Total Patients Enrolled
35 Trials studying Breast Cancer
38,409 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,744 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,250 Patients Enrolled for Breast Cancer
Heather NeumanPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
11 Total Patients Enrolled
1 Trials studying Breast Cancer
11 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or will not become pregnant during the study.I received chemotherapy for early-stage, HER2 negative breast cancer in the last 6-24 months.My breast cancer is either triple-negative or HER2 positive, diagnosed within the last 5 years.I was diagnosed with early-stage, hormone-positive, HER2-negative breast cancer in the last 6-24 months.
Research Study Groups:
This trial has the following groups:- Group 1: REASSURE Follow Up care
- Group 2: Usual Follow Up Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is the ideal candidate for participation in this research program?
"This medical study is seeking to enrol 100 individuals who fit the following criteria: between 18 and 95 years of age, have been diagnosed with stage I breast cancer which tests positive for estrogen receptor/progesterone receptor but negative for her2neu, has had 6-24 months since diagnosis, and is willing to complete all trial protocols via email."
Answered by AI
Does this trial extend to persons aged sixty or older?
"According to the inclusion criteria, only those aged 18-95 are qualified for this medical trial. For younger and older age demographics respectively, there are 74 studies and 2506 studies available."
Answered by AI
Does this investigation have availability for new participants?
"According to the clinicaltrials.gov, this protocol is no longer recruiting participants. The initial posting was on 1st November 2022 and the latest update occurred at that same time. Although there are no current openings, 2601 other trials have open recruitment processes available as of now."
Answered by AI
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