A Phase 1 interventional study of Quality-of-Life Assessment and Questionnaire Administration in Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Supportive care
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 100 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
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 Assessment · Other: Questionnaire Administration · Other: Supportive Care
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Receive ICP tasks
Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive
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.
Time frame: 12 months
Change in patient behavior (activity)
Will be assessed, using McNemar's test to detect any differences.
Time frame: Baseline up to 12 months
Change in toxicity symptom burden
Will be assessed using a paired t-test.
Time frame: Baseline up to 12 months
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
Time frame: Baseline up to 12 months
Clinical workflow impact measured by implementation of the breast cancer survivorship interactive care plan in the practice
Time frame: 12 months
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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