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| ID | Type | Description | Link |
|---|---|---|---|
| ONC-BRST-2401 | Other Identifier | Atrium Health |
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| Name | Class |
|---|---|
| Atrium Health Levine Cancer Institute | OTHER |
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This study aims to evaluate the use of mobile technology as a communication tool among patients with breast cancer and measured its effect on patient-reported cancer-related distress, specifically focusing on young women as they often face unique challenges.
This is a prospective, randomized, two stage study. The target population is adult females ≥ 18 and ≤ 45 years of age with breast cancer with a National Comprehensive Cancer Network (NCCN) Distress Thermometer score of distress score ≥ 4. The study will be conducted at Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC). The hypothesis is that the social connectivity via the Mighty Pro Application, as well as the educational components available in the application, will decrease patients' cancer-related distress. This study aims to evaluate the feasibility of implementing the Mighty Pro Application and measure its efficacy at reducing distress among young women with breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Access to the Mighty Pro Application | Experimental | Participants will be given access to the Mighty Pro Application for 12 months. |
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| No Access to the Mighty Pro Application | No Intervention | Participants will not be given access to the Mighty Pro Application. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mighty Pro Application | Other | Access to Mighty Pro Application |
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| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Feasibility of Implementation of Mighty Pro App | Binary variable indicating if at least one encounter with the application occurred for at least 80% of the weeks during the observation period. At the Participant level, the scale is either 0 (less than 80% utilization of the Mighty Pro App at least once per week during the 26-week observation period) or 1 (80% or greater utilization of the Mighty Pro App App at least once per week during the the 26-week observation period). | 26 Weeks |
| Stage 2: Efficacy of the Mighty Pro App | Binary variable indicating if at least a 2-point improvement was achieved from baseline to 26 weeks. At the Participant level, the scale is either 0 (the study participant did not achieve at least a 2-point improvement from baseline to 26 weeks on the distress scale) or 1 (the study participant did achieve at least a 2-point improvement from baseline to 26 weeks on the distress scale). The distress scale ranges from 0 (no distress) to 10 (extreme distress). | 26 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the Mighty Pro App in Improving Distress Scores | Binary variable indicating if at least a 2-point improvement was achieved from baseline to 52 weeks. At the Participant level, the scale is either 0 (the study participant did not achieve at least a 2-point improvement from baseline to 52 weeks on the distress scale) or 1 (the study participant did achieve at least a 2-point improvement from baseline to 52 weeks on the distress scale). The distress scale ranges from 0 (no distress) to 10 (extreme distress). |
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Inclusion Criteria:
Exclusion Criteria:
- None
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maggie Dzhanumova | Contact | 704-754-3768 | margarita.dzhanumova@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Julie Fisher, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Levine Cancer | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 52 Weeks |
| Efficacy of the Mighty Pro App in Improving Distress Scores - Quantitative | Quantitative distress scores collected for each participant and for each time point. For each Participant and each time point a quantitative measure will be collected ranging from 0 (no distress) to 10 (extreme distress). | 52 Weeks |
| D017437 |
| Skin and Connective Tissue Diseases |