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

Phase 1

Completed

• Conditions: Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8
• Interventions: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Supportive Care

• Registration Number: NCT04693338
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2020-08-20
• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Primary Completion: 2023-05-17
• Study Completion: 2023-05-17
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (ICP)	Questionnaire Administration	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.
Supportive care (ICP)	Quality-of-Life Assessment	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.
Supportive care (ICP)	Supportive Care	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.

Primary Outcome Measures

Name	Time	Method
Symptoms assessment response rate	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 Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States