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Trial Title:
Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer
NCT ID:
NCT05609435
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
follow up care
low risk
health care delivery
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a randomized, trial of REASSURE vs usual care within UW Health oncology clinics
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
REASSURE
Description:
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.
Arm group label:
REASSURE Follow Up care
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
95 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
UW Health Oncology Clinics
Address:
City:
Madison
Zip:
53792
Country:
United States
Start date:
November 16, 2022
Completion date:
November 2025
Lead sponsor:
Agency:
University of Wisconsin, Madison
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Wisconsin, Madison
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05609435
