Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT05609435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2022-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Evaluating a Novel Follow-up Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer Survivors in Wisconsin
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: