Breast CancerREASSURENCT05047575
Remote Electronic Assessment of Survivors With Feedback Communication and Directed Referrals
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, 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. 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2021to 28 Jul 2022
- 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
- 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
Who cannot join
- receipt of chemotherapy
- non-English speakers
- pregnancy
- cancer recurrence (local, regional or distant) since the initial diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: Pilot Study of a Follow-up Intervention to Improve the Quality of Care for Low-Risk Breast Cancer Survivors
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- REASSURE
- Keywords
- low risk breast cancer, survivor, follow up care
- 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
Also called Remote Electronic Assessment of Survivors with Feedback Communication and Directed Referrals
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.
| Study group | Role | What they receive |
|---|---|---|
| REASSURE Cohort 1 | Experimental | 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). Receives: Other: REASSURE |
| REASSURE Cohort 2 | Experimental | 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). Receives: Other: REASSURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Number of Eligible Participants Enrolled
The investigator's goal is a 50% recruitment rate of eligible patients
Measured: 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.
Measured: 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).
Measured: 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.
Measured: up to 6 months
Secondary outcomes (5)
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?"
Measured: up to 9 months
Number of Participants Whose Concerns Were Addressed During the Preceding Visit
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start24 Aug 2021
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Neuman, MD, MS, FACS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047575
- Sponsor's protocol ID
- UW21062
- Other IDs
- Protocol Version 12/7/2021, A539713, 2021-0961
- Acronym
- REASSURE
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2021
- Last updated
- 9 Sep 2022
- 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 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Follow-up Intervention to Improve the Quality of Care for Low-Risk Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05047575
- Acronym / sponsor ID
- REASSURE / UW21062
- Conditions
- Breast Cancer
- Keywords
- low risk breast cancer, survivor, follow up care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 17 Sep 2021 (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, 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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REASSURE Cohort 1 | Experimental | Other: REASSURESurvivors 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). |
| REASSURE Cohort 2 | Experimental | Other: REASSURESurvivors 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). |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- receipt of chemotherapy
- non-English speakers
- pregnancy
- cancer recurrence (local, regional or distant) since the initial diagnosis
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 |
|---|---|---|
| REASSUREAlso: Remote Electronic Assessment of Survivors with Feedback Communication and Directed ReferralsREASSURE 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. | Other | REASSURE Cohort 1, REASSURE Cohort 2 |
Primary outcome
Feasibility: Number of Eligible Participants Enrolled
Time frame: up to 6 months
The investigator's goal is a 50% recruitment rate of eligible patients
Number of survivorship symptoms/concerns that were addressed during the follow-up visit following clinician review of the REASSURE PRO assessment
Time frame: up to 9 months
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.
Number of Participants who Replace or are Eligible to Replace a Medical Oncology Follow-Up visit with Feedback Communication
Time frame: up to 1 year
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).
Number of PRO-generated Referral Recommendations that are Concordant with Medical Oncology Opinion
Time frame: up to 6 months
The investigator's goal is to have 75% of referral recommendations be concordant with medical oncology opinion.
5 secondary outcomes
Percent of Survivors Who Would Recommend this Approach to other survivors
Time frame: up to 9 months
Number of Participants Whose Concerns Were Addressed During the Preceding Visit
Time frame: up to 6 months
Satisfaction with survivorship information measured with the Satisfaction with Information and Care Scale
Time frame: up to 6 months
Knowledge about survivorship issues measured with the Preparing for Life as a (New) Survivor (PLANS) Scale
Time frame: up to 6 months
Preparedness for survivorship issues measured with the Preparing for Life as a (New) Survivor (PLANS) Scale
Time frame: up to 6 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 9 Sep 2022.
- Individual participant dataSharing planned: No
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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, MD, MS, FACS 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 5 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 9 Sep 2022. 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?
Feasibility: Number of Eligible Participants Enrolled (time frame: up to 6 months). The study lists 4 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 9 Sep 2022.