NCT04693338

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Supportive Care	Receive ICP tasks

Timeline

• Start date: 2020-08-20
• Primary completion: 2023-05-17
• Completion: 2023-05-17
• First posted: 2021-01-05
• Last updated: 2023-09-15

Locations

1 site across 1 country: United States