Interactive Care Plan for the Monitoring of Symptoms and Recovery in Patients With Stage 0-III Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This phase I trial evaluates how well a mobile device-based breast cancer survivorship interactive care plan works in monitoring symptoms and recovery in patients with stage 0-III breast cancer. The interactive care plan provides patients with individualized, 'just in time' education materials to promote self-management for those reporting difficult to control symptoms, as well as escalations to contact their care team for signs or symptoms concerning for cancer coming back (recurrence). The interactive care plan may help alleviate the symptoms of fatigue, insomnia, hot flashes, and sexual dysfunction; increase physical activity level and improve quality of life in patients with breast cancer.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To evaluate the feasibility and usability of the breast cancer (BC) survivorship interactive care plan (ICP) as designed. II. To determine the behavioral, toxicity symptom burden and quality of life (QOL) changes in patients engaged with the ICP. III. To assess clinical workflow impact by the introduction of the ICP in the BC survivor practice. OUTLINE: Patients complete surveys for 4 common symptoms: fatigue, hot flashes, insomnia, and sexual dysfunction and receive educational material via mobile application (app) to help with bothersome symptoms. Patients also complete questionnaires.

Official Title
-----------------
Assessing the Usability and Workflow Impact of a Mobile-Based Breast Cancer Survivorship Care Plan in the Oncology Practice

Conditions
-----------------
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8

Intervention / Treatment
-----------------
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Other: Supportive Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recently diagnosed and treated for breast cancer -- having a biopsy-proven, stage 0-III breast cancer and are within 12 months of completion of loco-regional breast cancer treatment and (as indicated) neoadjuvant and/or adjuvant chemotherapy. Ongoing treatment with adjuvant endocrine, bisphosphonate, and single-agent, HER2-directed therapy during the study period is allowed Willing to install an application (APP) on personal smart device Exclusion Criteria: Unwilling to return to Mayo Clinic for routine follow-up visits Unwilling to use the Mayo Clinic Mobile App Unable to provide consent Unable to speak or read English Unable to participate in mild activity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (ICP)<br>Patients complete surveys for 4 common symptoms: fatigue, hot flashes, insomnia, and sexual dysfunction and receive educational material via mobile app to help with bothersome symptoms. Patients also complete questionnaires. | Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Supportive Care<br>* Receive ICP tasks<br>* Other names: Therapy, Supportive;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms assessment response rate | Will assess the total response rate of all surveys administered over the course of the study. The interaction with the educational materials and reminders will be similarly assessed as a total proportion of interaction with the materials and reminders. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient behavior (activity) | Will be assessed, using McNemar's test to detect any differences. | Baseline up to 12 months | 
| Change in toxicity symptom burden | Will be assessed using a paired t-test. | Baseline up to 12 months | 
| Change in quality of life (QOL) | The statistical significance of this outcome will be tested using a paired t-test to compare baseline and study end QOL questionnaire completion | Baseline up to 12 months | 
| Clinical workflow impact measured by implementation of the breast cancer survivorship interactive care plan in the practice |  | 12 months |