NCT04693338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

2.7 years

First QC Date

October 12, 2020

Last Update Submit

September 14, 2023

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (4)

  • 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

Study Arms (1)

Supportive care (ICP)

EXPERIMENTAL

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.

Other: Quality-of-Life AssessmentOther: Questionnaire AdministrationOther: Supportive Care

Interventions

Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Supportive care (ICP)
Questionnaire AdministrationOTHER

Ancillary studies

Supportive care (ICP)
Supportive CareOTHER

Receive ICP tasks

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive
Supportive care (ICP)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Breast Carcinoma In Situ

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Carcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast NeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Daniela L Stan, M.D.

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2020

First Posted

January 5, 2021

Study Start

August 20, 2020

Primary Completion

May 17, 2023

Study Completion

May 17, 2023

Last Updated

September 15, 2023

Record last verified: 2023-09

Locations

US(1)