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Breast cancer treatment often results in long-term arm morbidity. A prospective surveillance model with arm assessment pre-surgery followed by ongoing surveillance and targeted physiotherapy treatment after breast cancer surgery may improve early detection and management of arm morbidity. This study aims to determine the effect of prospective surveillance to target physiotherapy on the prevalence of arm morbidity in the surveillance group compared to control group at 12-months after breast cancer surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Surveillance Group | Experimental | Women assigned to surveillance group were assessed for arm morbidity at pre-surgery and at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any time-point post-surgery, then a physiotherapy intervention was prescribed. |
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| Education Group | Active Comparator | Participants in the education group received the usual post-operative follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospective Surveillance Group | Behavioral | Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Arm Morbidity at 12 Months Post-surgery - Shoulder Mobility | Arm morbidity due to decreased shoulder mobility was defined as ≥10% decrease in mobility from pre-surgery. This was measured using a goniometer and evaluated the degrees of shoulder mobility in flexion, abduction and external rotation. | 12 months |
| Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Muscle Strength | Arm morbidity due to decreased upper body muscle strength was defined as ≥25% decrease in muscle strength from pre-surgery. This was measured using a hand-held dynamometer and evaluated in kilograms. | 12 months |
| Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Function | Arm morbidity due to decreased upper body function was defined as ≥10 points decrease in function from pre-surgery. This was measured using the Upper Extremity Functional Index that scores 0 to 80, with higher scores indicating greater level of function. | 12 months |
| Number of Participants With Arm Morbidity at 12 Months Post-surgery - Arm Volume | Arm morbidity due to increase in arm volume was defined as a ≥200 mL increase from pre-surgery. Arm volume was measured using a perometer. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Campbell, PhD | kristin.campbell@ubc.ca | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prospective Surveillance Group | Women assigned to surveillance group were assessed for arm morbidity at pre-surgery and at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any time-point post-surgery, then a physiotherapy intervention was prescribed. Prospective Surveillance Group: Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved. |
| FG001 | Education Group | Participants in the education group received the usual post-operative follow-up. Education Group: Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prospective Surveillance Group | Women assigned to surveillance group were assessed for arm morbidity at pre-surgery and at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any time-point post-surgery, then a physiotherapy intervention was prescribed. Prospective Surveillance Group: Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Arm Morbidity at 12 Months Post-surgery - Shoulder Mobility | Arm morbidity due to decreased shoulder mobility was defined as ≥10% decrease in mobility from pre-surgery. This was measured using a goniometer and evaluated the degrees of shoulder mobility in flexion, abduction and external rotation. | Posted | Count of Participants | Participants | 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prospective Surveillance Group | Women assigned to surveillance group were assessed for arm morbidity at pre-surgery and at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any time-point post-surgery, then a physiotherapy intervention was prescribed. Prospective Surveillance Group: Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kristin Campbell | University of British Columbia | 604-827-4704 | kristin.campbell@ubc.ca |
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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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| Education Group | Behavioral | Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff. |
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| BG001 | Education Group | Participants in the education group received the usual post-operative follow-up. Education Group: Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Education Group | Participants in the education group received the usual post-operative follow-up. Education Group: Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff. |
|
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| Primary | Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Muscle Strength | Arm morbidity due to decreased upper body muscle strength was defined as ≥25% decrease in muscle strength from pre-surgery. This was measured using a hand-held dynamometer and evaluated in kilograms. | Posted | Count of Participants | Participants | 12 months |
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|
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| Primary | Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Function | Arm morbidity due to decreased upper body function was defined as ≥10 points decrease in function from pre-surgery. This was measured using the Upper Extremity Functional Index that scores 0 to 80, with higher scores indicating greater level of function. | Posted | Count of Participants | Participants | 12 months |
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| Primary | Number of Participants With Arm Morbidity at 12 Months Post-surgery - Arm Volume | Arm morbidity due to increase in arm volume was defined as a ≥200 mL increase from pre-surgery. Arm volume was measured using a perometer. | Posted | Count of Participants | Participants | 12 months |
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| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Education Group | Participants in the education group received the usual post-operative follow-up. Education Group: Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff. | 0 | 19 | 0 | 19 |
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| D017437 |
| Skin and Connective Tissue Diseases |