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| Name | Class |
|---|---|
| Alberta Health services | OTHER |
| Canadian Breast Cancer Foundation | OTHER |
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Women who have undergone breast cancer surgery may develop swelling of the arm on the side the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This study will examine night-time compression system garments for lymphedema. Our objective is to determine if breast cancer survivors are willing and able to use the garment overnight to help control their lymphedema. Thirty breast cancer survivors from Alberta will be enrolled in the 24-week long study. Measurements will be taken of each arm to assess the extent of lymphedema and to measure changes over the study period. We will also examine other outcomes such as the impact of the night-time compression system garment on sleep. The study will provide important information on the feasibility of night-time compression system garments as a self-management strategy for lymphedema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Night-time Compression | Experimental | Women randomized to the immediate night-time compression system group will be measured for a custom-made night-time compression system. Women in this group will be instructed to wear their night-time compression system garment for a minimum of 5 nights per week over the 12-week intervention period. A gradual increase in nights worn and wear-time of the garment will occur over the first two weeks. From weeks 3 to 12 of the study, the participants will be asked to wear the garment for 8 hours per night, for a minimum of five nights per week. |
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| Delayed Group: Standard Care | Active Comparator | Women randomized to the delayed night-time compression system group will receive standard care for lymphedema maintenance. Each participant will be instructed to wear their day-time compression sleeve with or without a glove/ gauntlet, providing a minimum of 30 mm Hg of pressure, for twelve hours per day, each day of the week. Following the twelve-week delay period, women in this arm of the trial will be fitted for their respective night-time compression system garment and will follow the protocol outlined in the experimental arm of the trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Night-time compression system garment | Behavioral | Night-time compression system garment 8 hours per night for a minimum of 5 nights per week. |
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| Measure | Description | Time Frame |
|---|---|---|
| Accrual rate | The number of women eligible for the study and number agreeing to participate. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Data on adherence to wearing the night-time compression system. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret L. McNeely, PhD | University of Alberta and Alberta Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Cross Centre | Calgary | Alberta | T2S 3C1 | Canada | ||
| Cross Cancer Institute |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Day-time compression sleeve | Behavioral | Standard care for lymphedema maintenance. Day-time compression sleeve with or without a glove/ gauntlet, providing a minimum of 30 mm Hg of pressure, for twelve hours per day, each day of the week. |
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| Edmonton |
| Alberta |
| T6G 1Z2 |
| Canada |
| D017437 |
| Skin and Connective Tissue Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |