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| ID | Type | Description | Link |
|---|---|---|---|
| P50MH122351 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study evaluates the complex relationships between mental health, cognitive function, and physical activity before surgery in patients with stage I-III breast cancer. Most patients with breast cancer experience declines in their mental health, with up to two-thirds of patients reporting symptoms of depression and anxiety. Cancer-related cognitive decline is even more prevalent; 75% of patients with breast cancer report varying degree of loss in mental acuity throughout their cancer experience. Both mental and cognitive health declines are pervasive, lasting anywhere from 5 years to decades after treatment completion. Not only are these declines detrimental to patients' quality of life, but they also increase the risk of cancer-related mortality. Maintaining sufficient levels of physical activity (PA) is important to both prevent breast cancer and improve health post-diagnosis. PA improves anxiety and depressive symptoms during and after treatment. Early intervention with PA prior to or during cancer treatment, or prehabilitation, can avoid or reduce the severity of treatment-related side effects, hospital length of stay, surgical complications, and care costs. Information gained in this study may help researchers learn more about the right time during treatment for delivering lifestyle programs to improve mental and cognitive health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Participants wear ActiGraphs, complete questionnaires via phone call/text message, and participate in interviews remotely on study. |
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| Stakeholders | Semi-structured interviews will be conducted with up to 15 key stakeholders (e.g., nurse coordinators, surgical and medical oncologists, physical therapists) at Siteman Cancer Center. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actigraph | Other | Participants will wear an Actigraph hip-worn accelerometer on their non-dominant hip during all waking hours, and on the wrist while sleeping |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity | Assessed using an Actigraph hip-worn accelerometer | Through completion of surgery (estimated to be approximately 12-20 weeks) |
| Change in depression and anxiety | Assessed using the PHQ-ADS | Through completion of surgery (estimated to be approximately 12-20 weeks) |
| Change in cognitive function (self-reported) | Assessed using the FACT-Cog | Through completion of surgery (estimated to be approximately 12-20 weeks) |
| Change in cognitive function (objective) | Assessed using the BrainBaseline application | Through completion of surgery (estimated to be approximately 12-20 weeks) |
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Eligibility Criteria Patients:
Eligibility Criteria Stakeholders:
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Patients with stages I-III breast cancer at Siteman Cancer Center (SCC) and stakeholders drawn from the surrounding BJC and Washington University healthcare systems.
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Salerno, Ph.D., MPH | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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To protect participant privacy, deidentified individual participant data and study protocol will be made available to researchers who provide a methodologically sound proposal for any purpose, immediately following publication
Following publication.
Proposals should be directed to e.salerno@wustl.edu.
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| Questionnaires | Other |
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| BrainBaseline application | Other | Objective measures of cognitive function will include those from the BrainBaseline application, a validated research tool developed by Digital Artefacts to remotely measure domains of cognition |
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| Semi-structured interviews | Other | Semi-structured individual interviews will be conducted with up to 15 healthcare stakeholders and 15-30 patients with breast cancer at any time during the study period, as determined by participant preference. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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