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Due to COVID this trial never got up and running.
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| Name | Class |
|---|---|
| University of Toledo | OTHER |
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The purpose of this project is to determine the feasibility and effectiveness of a 6-week, internet-based, Energy Conservation and Activity Management intervention among women who report cancer-related fatigue following breast cancer treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Energy Conservation Work Simplification Education | Experimental | The intervention will be delivered online by an occupational therapist. The intervention consists of 6 weekly sessions; each session will be 45 minutes long. The focus of the intervention is to teach breast cancer survivors strategies to manage their fatigue. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy Conservation Work Simplification Education | Behavioral | The intervention will last approximately 45 minutes, and will be provided once/week for 6 weeks. The intervention is delivered "live" using web-cameras (e.g., Microsoft Zoom). Registered and licensed occupational therapists will deliver the intervention. At beginning of the intervention, the participant and interventionist prioritize the 5 most critical fatigue-related problems that they would like to solve during the intervention. Each week, the interventionist will guide the participant through a workbook to provide knowledge and examples on how to apply the knowledge to everyday fatigue-related problems. The workbook contains: (a) information regarding fatigue in breast cancer survivors, (b) knowledge regarding fatigue management strategies, and (c) worksheets to develop skills to recognize and solve fatigue-related problems. Participants will retain the workbook after study completion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fatigue Scores (Revised Piper Fatigue Scale) | Measure of fatigue severity and impact | Baseline to 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fatigue Impact (Patient Reported Outcomes Measurement Information System Fatigue Scale) | Measure of fatigue severity and impact | Baseline to 14 weeks |
| Change in Fatigue Impact (Modified Fatigue Impact Scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ketki Raina, PhD, OTR/L | University of Toledo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toledo | Toledo | Ohio | 43606 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Measure of fatigue impact
| Baseline at 14 weeks |
| Change in Severity of Fatigue Measured Via Ecological Momentary Assessments | Ecological Momentary Assessments via Smartphone App | Baseline to 14 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |