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| Name | Class |
|---|---|
| Northwestern Medicine | OTHER |
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The goal of this research study is to determine the feasibility and potential effects of physical therapy and enhanced patient education delivered before breast cancer treatment. Physical therapy before cancer treatment aims to help with early identification and self-management of physical and functional side effects from cancer treatment. Side effects could be joint pain, muscle weakness, or fatigue that contribute to functional impairment.
The main questions this study aims to answer are:
Participants will be randomly assigned to either of the two arms of the study which are 'Intervention' and 'Enhanced usual care.'
Participants in the intervention arm will receive:
1. Planned care per their oncology physician team plus: 1.1. Patient education on physical function in breast cancer 1.2. Physical therapy evaluation 1.3. Individualized home exercise prescription 1.4. Education materials in the form of a study booklet, study website, text messaging, and phone calls 1.5. Monthly monitoring of physical and functional survey scores to identify the need for physical therapy and provide referrals as needed
Participants in the enhanced usual care arm will receive:
1. Planned care per their oncology physician team plus 1.2. Monthly monitoring of their physical functional scores to identify the need for physical therapy and provide referrals as needed
All participants will attend three in-person visits for clinical measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients assigned to the intervention arm will receive the intervention named Moving On After Breast Cancer (MOve-ABC). |
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| Enhanced Usual Care (EUC) | Experimental | All patients will receive EUC. However, participants assigned to this arm will have only EUC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOve-ABC | Other | The intervention is called Moving On After Breast Cancer (MOve-ABC) and includes:
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility in terms of percentage of participants completing the study protocol | Through study completion, an average of one year | |
| Number of study participants with a score of less than 45 on the "Patient Reported Outcome Measurement Information System Physical Function Custom Form v2.0 Computerized Patient Reported Outcomes" | This questionnaire is a patient reported outcome measure to assess physical function status. The scores range from 23.9 to 58. Higher the score, higher is the physical function. | Baseline, Month 1, Month 2, Month 3, Month 4, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Average of all scores across the 6-items of Self-Efficacy for Managing Chronic Disease 6-Item (SEMCD-6) Scale | Scoring for each item is on a 1-10 scale where 1 is 'Not at all confident' and 10 is 'Totally Confident.' There are 6 such items. The scores of all the 6 items are combined and averaged to get the total score. The final score is between 1-10. Higher scores indicate higher self-efficacy. | Baseline, Month 3, Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Marie Flores, PT, MSPT, MA, PhD, CLT | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | 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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Pilot Randomized Controlled Trial
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| Enhanced Usual Care | Other | All patients will receive EUC. However, half of our sample will have only EUC consisting of
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| D017437 |
| Skin and Connective Tissue Diseases |