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Trial record 10 of 23 for:    cancer | Studies received from 04/22/2016 to 04/22/2016

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristin Campbell, University of British Columbia
ClinicalTrials.gov Identifier:
NCT02754427
First received: April 22, 2016
Last updated: May 16, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Breast Cancer Behavioral: Prospective Surveillance Group Behavioral: Education Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Kristin Campbell, University of British Columbia:

Primary Outcome Measures:
  • Arm morbidity at 12 months post-surgery - shoulder mobility [ Time Frame: 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.

  • Arm morbidity at 12 months post-surgery - upper body muscle strength [ Time Frame: 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.

  • Arm morbidity at 12 months post-surgery - upper body function [ Time Frame: 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.

  • Arm morbidity at 12 months post-surgery - arm volume [ Time Frame: 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.


Enrollment: 41
Study Start Date: February 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: Prospective surveillance for arm morbidity and physiotherapy treatment
Active Comparator: Education Group
Participants in the education group received the usual post-operative follow-up.
Behavioral: 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.
Other Name: Attention Control Group

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02754427

Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Kristin Campbell, PhD kristin.campbell@ubc.ca
  More Information

Responsible Party: Kristin Campbell, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02754427     History of Changes
Other Study ID Numbers: H12-01773
Study First Received: April 22, 2016
Last Updated: May 16, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Kristin Campbell, University of British Columbia:
Surveillance
Physiotherapy
Arm morbidity

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 18, 2017