Breast CancerNCT05609435
Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer
A study testing REASSURE in people with Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- REASSURE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2022to 27 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Health Oncology Clinics
Madison, Wisconsin, 53792
About this study
Official title: Evaluating a Novel Follow-up Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer Survivors in Wisconsin
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- REASSURE
- Keywords
- follow up care, low risk, health care delivery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REASSUREOther
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.
| Study group | Role | What they receive |
|---|---|---|
| REASSURE Follow Up care | Experimental | Not described Receives: Other: REASSURE |
| Usual Follow Up Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 18 months
Secondary outcomes (4)
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?".
Measured: 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.
Measured: up to 18 months
Number of Threshold-Level Symptoms Survivors Perceive are Addressed on each visit
Measured: 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.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start16 Nov 2022
- Primary completion27 Jan 2026
- Study completion27 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, trial of REASSURE vs usual care within UW Health oncology clinics
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Neuman, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609435
- Sponsor's protocol ID
- 2022-1157
- Other IDs
- SMPH/SURGERY/SURG ONC, Protocol Version 1/18/2024, UW22095, NCI-2022-10267
- Status last verified
- Aug 2025
- First submitted
- 1 Nov 2022
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Novel Follow-up Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer Survivors in Wisconsin
- ClinicalTrials.gov ID
- NCT05609435
- Acronym / sponsor ID
- 2022-1157
- Conditions
- Breast Cancer
- Keywords
- follow up care, low risk, health care delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 27 Jan 2026 (actual)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, trial of REASSURE vs usual care within UW Health oncology clinics
| Arm | Type | Receives |
|---|---|---|
| REASSURE Follow Up care | Experimental | Other: REASSURE |
| Usual Follow Up Care | No intervention | – |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REASSUREREASSURE 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. | Other | REASSURE Follow Up care |
Primary outcome
Preparing for Life as a (New) Survivor (PLANS) Scale Score: Part 1
Time frame: 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
Time frame: 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.
4 secondary outcomes
Number of Participants In Intervention Arm who would recommend this approach to follow-up to other survivors
Time frame: up to 18 months
Number of Threshold-Level Symptoms Reported on the PRO Assessment
Time frame: up to 18 months
Number of Threshold-Level Symptoms Survivors Perceive are Addressed on each visit
Time frame: up to 18 months
Number of Follow Up Visits
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Neuman principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REASSURE in people with Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preparing for Life as a (New) Survivor (PLANS) Scale Score: Part 1 (time frame: up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.