Breast Cancer
Conditions
Keywords
Surveillance, Physiotherapy, Arm morbidity
Brief summary
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.
Interventions
BEHAVIORALProspective 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.
BEHAVIORALEducation 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.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* age 30-75 years; receiving surgery for breast cancer, including those who will have immediate breast reconstruction.
Exclusion criteria
* prior breast cancer surgery; a pre-existing shoulder pathology on the side of breast surgery that limits shoulder range of motion \<75% of non-affected side; or a diagnosis of primary lymphedema
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Arm Morbidity at 12 Months Post-surgery - Shoulder Mobility | 12 months | 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. |
| Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Muscle Strength | 12 months | 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. |
| Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Function | 12 months | 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. |
| Number of Participants With Arm Morbidity at 12 Months Post-surgery - Arm Volume | 12 months | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 20 |
| Total | 41 |
Baseline characteristics
| Characteristic | Prospective Surveillance Group | Education Group | Total |
|---|---|---|---|
| Age, Continuous | 55.05 years STANDARD_DEVIATION 6.4 | 53.25 years STANDARD_DEVIATION 10 | 54.2 years STANDARD_DEVIATION 8.3 |
| Ethnicity (NIH/OMB) Ethnicity Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Ethnicity Not Hispanic or Latino | 21 Participants | 20 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Ethnicity Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Surveillance Group | Number of Participants With Arm Morbidity at 12 Months Post-surgery - Arm Volume | 0 Participants |
| Education Group | Number of Participants With Arm Morbidity at 12 Months Post-surgery - Arm Volume | 1 Participants |
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Surveillance Group | Number of Participants With Arm Morbidity at 12 Months Post-surgery - Shoulder Mobility | 5 Participants |
| Education Group | Number of Participants With Arm Morbidity at 12 Months Post-surgery - Shoulder Mobility | 7 Participants |
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Surveillance Group | Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Function | 5 Participants |
| Education Group | Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Function | 3 Participants |
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Surveillance Group | Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Muscle Strength | 1 Participants |
| Education Group | Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Muscle Strength | 4 Participants |