Clinical trial NCT05609435: Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer
Official title: Evaluating a Novel Follow-up Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer Survivors in Wisconsin
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: follow up care
low risk
health care delivery
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-11-08
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, trial of REASSURE vs usual care within UW Health oncology clinics
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Preparing for Life as a (New) Survivor (PLANS) Scale Score: Part 1
timeFrame: up to 18 months
measure: Preparing for Life as a (New) Survivor (PLANS) Scale Score: Part 2
timeFrame: up to 18 months
Secondary outcomes:
measure: Number of Participants In Intervention Arm who would recommend this approach to follow-up to other survivors
timeFrame: up to 18 months
measure: Number of Threshold-Level Symptoms Reported on the PRO Assessment
timeFrame: up to 18 months
measure: Number of Threshold-Level Symptoms Survivors Perceive are Addressed on each visit
timeFrame: up to 18 months
measure: Number of Follow Up Visits
timeFrame: up to 18 months
Other outcomes:
measure: Number of Participants Who Received Recommended Cancer Care
timeFrame: up to 18 months
measure: Survivors' Experiences: Impact of Event Scale
timeFrame: up to 18 months
measure: Survivors' Experiences: Satisfaction with Information
timeFrame: up to 18 months
measure: Survivors' Experiences: Human Connection Scale Score
timeFrame: up to 18 months
measure: Survivors' Experiences: Quality of Follow Up Care
timeFrame: up to 18 months
measure: Healthcare Utilization: Number of Visits and Services Used
timeFrame: up to 18 months
measure: Healthcare Utilization: Number of MyChart Visits and Phone Calls
timeFrame: up to 18 months
Locations:
city: Madison
country: United States
facility: UW Health Oncology Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Heather Neuman
role: PRINCIPAL_INVESTIGATOR
References: