Clinical trial NCT04693338: Interactive Care Plan for the Monitoring of Symptoms and Recovery in Patients With Stage 0-III Breast Cancer
Official title: Assessing the Usability and Workflow Impact of a Mobile-Based Breast Cancer Survivorship Care Plan in the Oncology Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-01-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Symptoms assessment response rate
timeFrame: 12 months
Secondary outcomes:
measure: Change in patient behavior (activity)
timeFrame: Baseline up to 12 months
measure: Change in toxicity symptom burden
timeFrame: Baseline up to 12 months
measure: Change in quality of life (QOL)
timeFrame: Baseline up to 12 months
measure: Clinical workflow impact measured by implementation of the breast cancer survivorship interactive care plan in the practice
timeFrame: 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Daniela L Stan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: