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

NCT02754427 | Completed Results

• 1 other identifier: H12-01773
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

Surveillance; Physiotherapy; Arm morbidity

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Behavioral: Prospective Surveillance Group

Education Group

ACTIVE COMPARATOR

Participants in the education group received the usual post-operative follow-up.

Behavioral: Education Group

Interventions

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.

Also known as: Prospective surveillance for arm morbidity and physiotherapy treatment

Prospective Surveillance Group

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.

Also known as: Attention Control Group

Education Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 30-75 years; receiving surgery for breast cancer, including those who will have immediate breast reconstruction.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Kristin Campbell
• Organization: University of British Columbia

kristin.campbell@ubc.ca

604-827-4704

Study Officials

• Kristin Campbell, PhD

  kristin.campbell@ubc.ca

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: April 28, 2016
• Study Start: February 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 25, 2019
• Results First Posted: October 25, 2019

Record last verified: 2019-10