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The Breast Cancer Online Rehabilitation Program (BRECOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673918
Recruitment Status : Completed
First Posted : February 4, 2016
Results First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Kristin Campbell, University of British Columbia

Brief Summary:

The investigators have developed an online rehabilitation platform to guide women in their home-based upper-body exercises after breast cancer surgery. The platform includes rehabilitation videos that will guide the women in performing home-based early post-surgery upper-body rehabilitation tailored for each individual.

The primary objective is to assess the feasibility and acceptability of a home-based rehabilitation program supported by a supplemental online platform for women after breast cancer surgery before conducting a larger pragmatic trial in the future. The feasibility of the platform will be tested in 11 municipalities in Denmark.


Condition or disease Intervention/treatment Phase
Breast Cancer Other: Home-based upper-body rehabilitation with online support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study was conducted in two parts and thereby had two groups of participants. Part 1 participants were newly operated for breast cancer. Part 2 participants had completed surgery and radiation therapy for breast cancer. Both groups received the same intervention, namely a home-based rehabilitation program.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Breast Cancer Online Rehabilitation Program: A Feasibility Study of Individually Tailored Online Rehabilitation After Breast Cancer Surgery The Copenhagen BRECOR Program
Study Start Date : February 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1: Rehabilitation after surgery for breast cancer
Home-based upper-body rehabilitation with online support
Other: Home-based upper-body rehabilitation with online support

Participants will be given written educational material, in which the physiotherapist marks the exercises specifically recommended for the individual patient. In addition, participants will get a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.

On average, participants will complete three rehabilitation exercises 5-7 times weekly with an anticipated duration of approximately 20 minutes.


Experimental: Part 2: Rehabilitation after radiation for breast cancer
Home-based upper-body rehabilitation with online support
Other: Home-based upper-body rehabilitation with online support

Participants will be given written educational material, in which the physiotherapist marks the exercises specifically recommended for the individual patient. In addition, participants will get a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.

On average, participants will complete three rehabilitation exercises 5-7 times weekly with an anticipated duration of approximately 20 minutes.





Primary Outcome Measures :
  1. Recruitment Rate [ Time Frame: 10 weeks for part 1 and 20 weeks for part 2 ]
    This outcome represent the number and proportion (%) of eligible patients who consented to participate in the study. Recruitment was open for 10 weeks for participants in Part 1 and for 20 weeks for participants in Part 2.

  2. Retention [ Time Frame: 12 weeks ]
    Participants who are enrolled in the study but fail to complete the end of study assessment will be recorded as dropouts. Feasibility will be defined as a drop out of <10%

  3. Number of Participants Reporting Being "Very Satisfied" or "Somewhat Satisfied" With the Program [ Time Frame: 12 weeks ]
    At the end of the study data describing participant satisfaction will be collected to answers questions on acceptability. All participants in part 1 and part 2 will be given a questionnaire, delivered by Easy Research, and will be asked to rank various aspects of the intervention such as the home-based exercises supported by videos, mode of delivery, software, etc. "as not at all satisfied", "not very satisfied", "somewhat satisfied" or "very satisfied". Feasibility will be defined as >75% of participants reporting they are "very" or "somewhat satisfied" with the intervention.

  4. Capacity/ Resources [ Time Frame: 12 weeks ]
    The amount of time spent with each participant during the standard upper-body assessments, instruction of the home-based intervention and assistance needed with using the website during the study period will be tracked. In addition, any additional appointments required to teach the home-based rehabilitation program or to assist in using the website will be recorded. This information will help to determine the resources needed to administer the online component of the home-based program on a larger scale to a broader group of participants. This data was only collected for Part 1.

  5. Adherence [ Time Frame: 12 weeks ]
    Participants in part 1 and part 2 were asked to perform the rehabilitation program at least four times weekly for the duration of the study (12 weeks). Adherence was calculated as the number and proportion of participants who reported in a follow-up questionnaire that they had performed four or more weekly sessions. As such, participants who reported to have completed the home-based rehabilitation program 4 times per week were categorized as having adhered to the program. Likewise, participants who reported to have completed the program 3 times or fewer per week were categorized as not having adhered to the program.


Secondary Outcome Measures :
  1. Motivation for Rehabilitation Exercises [ Time Frame: 12 weeks ]
    To answers questions on motivation, the participants' reaction to the intervention, intend to use, and perceived appropriateness of the rehabilitation exercises will be answered. Behavioral changes in motivation to do home-based rehabilitation exercises will be measured as this is fundamental to adherence. The study method is theoretically based in the framework of Theory of Planned Behavior and has been validated in measuring motivation for exercise among cancer survivors including breast cancer patients. The Intention, Attitude and Subjective Norm Questionnaire is a 19-item Theory of Planned Behavior questionnaire modified for use with online home-based rehabilitation. All questions are answered using a 7 point Likert scale and produces effect sizes (Cohen's D). The Theory of Planned Behavior scale is scored on a 0 to 7 scale with a higher score indicating a greater level of motivation.

  2. Clinical Outcomes in Upper-body Function: Mobility [ Time Frame: 12 weeks ]
    Active shoulder mobility for flexion and external rotation. Changes from baseline to follow-up (12 weeks later) will be calculated. This data was only collected for participants in part 1.

  3. Clinical Outcomes in Upper-body Function: Muscle Strength [ Time Frame: 12 weeks ]
    Upper body muscle strength was tested using Manual Muscle Testing among participants in part 1 only.

  4. Clinical Outcomes in Upper-body Function: Arm Circumference [ Time Frame: 12 weeks ]
    Arm circumference at 5 points along the arm. Changes from baseline will be calculated.

  5. Clinical Outcomes in Upper-body Function: Pain [ Time Frame: 12 weeks ]
    Patient-reported pain on a 0-10 Visual Analogue Scale in the breast/arm region. A higher score indicates greater level of pain. Changes from baseline will be calculated. This data was only collected for part 1.

  6. Ability to Perform Activities of Daily Living [ Time Frame: 12 weeks ]
    QuickDASH (Disabilities of the Arm, Shoulder, and Hand) scores 0 to 100 with higher scores indicating more limitations in upper-body functioning.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of breast cancer
  • Part 1 only: Surgery for breast cancer within the past eight weeks (mastectomy or lumpectomy with either sentinel or axillar dissection), including those women with a history of previous surgery for breast cancer, radiation therapy or chemotherapy
  • Part 2 only: Completion of surgery and radiation therapy for breast cancer within the past six weeks.
  • Home access to internet from stationary computer, lab top or tablet
  • Ability to use internet
  • Ability to read and understand Danish

Exclusion Criteria:

  • Surgery for breast cancer with immediate breast reconstruction
  • Diagnosis of primary lymphedema
  • Metastatic or inflammatory breast cancer
  • Planned use of chemotherapy within the next 6 weeks
  • Surgical complications: infection, drainage issues, seroma, hematoma
  • Severe physical, cognitive, or psychiatric illness causing inability to follow the study protocol: i.e. severe depression, anxiety, dementia, poor physical health with likely possibility of hospitalization within the next twelve weeks.
  • Planned hospitalization or surgery within the next twelve weeks
  • Participation in another clinical trial with a rehabilitation or exercise intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673918


Locations
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Denmark
Tranehaven
Charlottenlund, Denmark, 2920
Copenhagen Centre for Cancer and Health
Copenhagen, Denmark, 2200
Sundhedscenter Frederiksberg
Frederiksberg, Denmark, 2000
Lukas
Hellerup, Denmark, 2900
Træningscenteret Møllebo
Lyngby, Denmark, 2800
Furesø Kommunes Genoptræningscenter
Værløse, Denmark, 3500
Sponsors and Collaborators
University of British Columbia
University of Copenhagen
Investigators
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Principal Investigator: Kristin Campbell, PhD University of British Columbia
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Responsible Party: Kristin Campbell, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02673918    
Other Study ID Numbers: CCCH-UBC 01
First Posted: February 4, 2016    Key Record Dates
Results First Posted: December 13, 2019
Last Update Posted: December 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kristin Campbell, University of British Columbia:
Rehabilitation
Home-Based Intervention
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases