N/A
N=59
The Breast Cancer Online Rehabilitation Program
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02673918 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Recruitment Rate — 35; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home-based upper-body rehabilitation with online support (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of British Columbia
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Rate |
35; 24 | — |
| PRIMARY Retention |
29; 20 | — |
| PRIMARY Number of Participants Reporting Being "Very Satisfied" or "Somewhat Satisfied" With the Program |
16; 12 | — |
| PRIMARY Capacity/ Resources |
92.4 | — |
| PRIMARY Adherence |
21; 9 | — |
| SECONDARY Motivation for Rehabilitation Exercises |
6.45; 6.38; 4.82; 4.45; 6.20; 5.69 | — |
| SECONDARY Clinical Outcomes in Upper-body Function: Mobility |
19; 0; 13; 0; 1; 0 | 0.05 |
| SECONDARY Clinical Outcomes in Upper-body Function: Muscle Strength |
25; 0; 9; 0; 0; 0 | 0.05 |
| SECONDARY Clinical Outcomes in Upper-body Function: Arm Circumference |
— | — |
| SECONDARY Clinical Outcomes in Upper-body Function: Pain |
1.0; 1.0 | — |
| SECONDARY Ability to Perform Activities of Daily Living |
19.8; 13.5; 15.2; 11.0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02673918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.