search
Back to results

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

Primary Purpose

Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Quality-of-Life Assessment
Questionnaire Administration
Supportive Care
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anatomic Stage 0 Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (ICP)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in patient behavior (activity)
Will be assessed, using McNemar's test to detect any differences.
Change in toxicity symptom burden
Will be assessed using a paired t-test.
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
Clinical workflow impact measured by implementation of the breast cancer survivorship interactive care plan in the practice

Full Information

First Posted
October 12, 2020
Last Updated
September 14, 2023
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04693338
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2020 (Actual)
Primary Completion Date
May 17, 2023 (Actual)
Study Completion Date
May 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (ICP)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Supportive Care
Other Intervention Name(s)
Supportive Therapy, Symptom Management, Therapy, Supportive
Intervention Description
Receive ICP tasks
Primary Outcome Measure Information:
Title
Symptoms assessment response rate
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in patient behavior (activity)
Description
Will be assessed, using McNemar's test to detect any differences.
Time Frame
Baseline up to 12 months
Title
Change in toxicity symptom burden
Description
Will be assessed using a paired t-test.
Time Frame
Baseline up to 12 months
Title
Change in quality of life (QOL)
Description
The statistical significance of this outcome will be tested using a paired t-test to compare baseline and study end QOL questionnaire completion
Time Frame
Baseline up to 12 months
Title
Clinical workflow impact measured by implementation of the breast cancer survivorship interactive care plan in the practice
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela L Stan, M.D.
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs