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

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754427
• Other study ID #: H12-01773
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2019
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 months
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.	12 months
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.	12 months
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.	12 months