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The purpose of this single-site non-randomized study is to identify areas of need related to functional status and overall health, including nutrition and mental health in subjects with metastatic breast cancer (MBC). A decline in functional status is observed after breast cancer diagnosis and exacerbated by treatment. Declining functional status impacts the quality of life and can lead to increased comorbidity burden, hospitalization, and increased mortality. Functional status is assessed by specific provider-graded scales. Patient Reported Outcome (PRO) measures may better assess certain aspects of patient health and symptom domains. Thus, potentially supporting the future implementation of effective prehabilitation strategies. This study explores whether a PRO-based survey will identify the physical and emotional health and the social and financial status of patients newly diagnosed with MBC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Subjects with metastatic breast carcinoma have been receiving treatment at the study center and responding to survey questionnaires. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General health survey questionnaires | Other | Patient-reported outcome survey will be offered at baseline. |
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| Measure | Description | Time Frame |
|---|---|---|
| Physical activity levels | Physical activity levels will be measured using the Godin Leisure-Time Exercise Questionnaire. Godin Leisure-Time Exercise Questionnaire has 3 dichotomous questions, answers will be "yes" or "no". There will be reason questions if the answer is no. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of survey | Acceptability of survey to subjects will be measured by the percentage of eligible patients who complete the survey. | Baseline |
| Health-related quality of life - FACT-G |
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In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Inclusion Criteria:
Exclusion Criteria:
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Subject with metastatic breast cancer receive treatment at the University of North Carolina, Lineberger Comprehensive Cancer Center.
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| Name | Affiliation | Role |
|---|---|---|
| Sasha Knowlton, MD | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| Clinical trials at UNC Lineberger | View source |
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| PROMIS Cancer Function Brief 3D profile questionnaires | Other | Patient-reported outcome survey will be offered at baseline. |
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| FACT-G questionnaires | Other | Patient-reported outcome survey will be offered at baseline. |
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| Godin Leisure-Time Exercise Questionnaire | Other | Patient-reported outcome survey will be offered at baseline. |
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| REAP-S questionnaires | Other | Patient-reported outcome survey will be offered at baseline. |
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Health-related quality of life will be measured by Functional Assessment of Cancer Therapy (FACT-G) which is a survey assessing physical, emotional, and functional well-being on a Likert-type scale. higher scores demonstrating higher health-related quality of life, from 0 to 4. Higher scores represent better QOL.
| Baseline |
| Health-related quality of life - PROMIS | The patient-Reported Outcomes Measurement Information System (PROMIS) survey will assess physical function, fatigue, and social participation. This survey was designed for cancer rehabilitation needs. It asks patients on a Likert-type scale about their ability to perform mobility and activities of daily living tasks along with the frequency of fatigue and ability to participate in vocational and avocational activities. | Baseline |
| Diet quality | The diet quality will be measured using a modified version of the Rapid Eating Assessment for Participants (REAP-S) survey will assess diet and nutrition quality. For the general population, a score of 32 or higher determines a high-quality/desirable diet. The survey asks about the intake of nutrients including vegetables/fruit, whole grains, types of fat, calcium-rich foods, and others. Responses usually/often receive 1 point, sometimes receive 2 points, and rarely/do not apply to receive 3 points. | Baseline |
| the percentage of subjects referred | the percentage of subjects referred will be defined as subjects who have been referred to or used Lineberger Comprehensive Cancer Center supportive services for patients Referral rates will be reported for an array of the University of North Carolina Lineberger supportive services by questionnaire. | Baseline |
| Barriers to access exercise | Barriers to accessing exercise will be evaluated by questionnaire. | Baseline |
| health-related opinions | Health-related opinions regarding prehabilitation interventions will be assessed by questionnaire which includes open-ended questions. | Baseline |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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