NCT02673918

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

December 13, 2019

Completed
Last Updated

December 13, 2019

Status Verified

November 1, 2019

Enrollment Period

10 months

First QC Date

January 12, 2016

Results QC Date

November 5, 2018

Last Update Submit

November 22, 2019

Conditions

Breast Cancer

Keywords

RehabilitationHome-Based Intervention

Outcome Measures

Primary Outcomes (5)

  • Recruitment Rate

    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.

    10 weeks for part 1 and 20 weeks for part 2

  • Retention

    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%

    12 weeks

  • Number of Participants Reporting Being "Very Satisfied" or "Somewhat Satisfied" With the Program

    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.

    12 weeks

  • Capacity/ Resources

    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.

    12 weeks

  • Adherence

    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.

    12 weeks

Secondary Outcomes (6)

  • Motivation for Rehabilitation Exercises

    12 weeks

  • Clinical Outcomes in Upper-body Function: Mobility

    12 weeks

  • Clinical Outcomes in Upper-body Function: Muscle Strength

    12 weeks

  • Clinical Outcomes in Upper-body Function: Arm Circumference

    12 weeks

  • Clinical Outcomes in Upper-body Function: Pain

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Part 1: Rehabilitation after surgery for breast cancer

EXPERIMENTAL

Home-based upper-body rehabilitation with online support

Other: Home-based upper-body rehabilitation with online support

Part 2: Rehabilitation after radiation for breast cancer

EXPERIMENTAL

Home-based upper-body rehabilitation with online support

Other: Home-based upper-body rehabilitation with online support

Interventions

Home-based upper-body rehabilitation with online supportOTHER

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.

Part 1: Rehabilitation after surgery for breast cancerPart 2: Rehabilitation after radiation for breast cancer

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Tranehaven

Charlottenlund, 2920, Denmark

Location

Copenhagen Centre for Cancer and Health

Copenhagen, 2200, Denmark

Location

Sundhedscenter Frederiksberg

Frederiksberg, 2000, Denmark

Location

Lukas

Hellerup, 2900, Denmark

Location

Træningscenteret Møllebo

Lyngby, 2800, Denmark

Location

Furesø Kommunes Genoptræningscenter

Værløse, 3500, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Bolette Rafn
Organization
University of British Columbia
bolette.rafn@ubc.ca
604-827-1914

Study Officials

  • Kristin Campbell, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 12, 2016

First Posted

February 4, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

December 13, 2019

Results First Posted

December 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(6)