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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-07744 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19-002448 | Other Identifier | Mayo Clinic in Rochester | |
| P30CA015083 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient behavior (activity) | Will be assessed, using McNemar's test to detect any differences. | Baseline up to 12 months |
| Change in toxicity symptom burden | Will be assessed using a paired t-test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniela L Stan, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2021 | Sep 14, 2023 |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Supportive Care | Other | Receive ICP tasks |
|
|
| 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 | Baseline up to 12 months |
| Clinical workflow impact measured by implementation of the breast cancer survivorship interactive care plan in the practice | 12 months |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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