Assessing the Usability and Workflow Impact of a Mobile-Based Breast Cancer Survivorship Care Plan in the Oncology Practice
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8
- Sponsor
- Mayo Clinic
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Symptoms assessment response rate
- Status
- Completed
- Last Updated
- 2 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
Symptoms assessment response rate
Time Frame: 12 months
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.
Secondary Outcomes
- Change in patient behavior (activity)(Baseline up to 12 months)
- Change in toxicity symptom burden(Baseline up to 12 months)
- Change in quality of life (QOL)(Baseline up to 12 months)
- Clinical workflow impact measured by implementation of the breast cancer survivorship interactive care plan in the practice(12 months)