Pilot Study for a Prospective Surveillance Program for Rehabilitation Following Surgery for Breast Cancer

Study Overview
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Brief Summary
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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.

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Prospective Surveillance Group
* Behavioral: Education Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective Surveillance Group<br>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. | Behavioral: Prospective Surveillance Group<br>* 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.<br>* Other names: Prospective surveillance for arm morbidity and physiotherapy treatment;|
| Active Comparator: Education Group<br>Participants in the education group received the usual post-operative follow-up. | Behavioral: Education Group<br>* 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.<br>* Other names: Attention Control Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surveillance, Physiotherapy, Arm morbidity