Breast Cancer Clinical Trial
— EmpowerOfficial title:
Exercise Rehabilitation Via a Mobile Application for Individuals With Breast Cancer Undergoing Chemotherapy (EMPOWER): A Randomized Controlled Feasibility Trial
The primary purpose of this study is to determine the feasibility of our proposed intervention approach involving (1) an integrated physiotherapy and exercise intervention for individuals with breast cancer who are undergoing chemotherapy and (2) delivery of programming via an electronic health (eHealth) application. The secondary objective is to determine the efficacy of the program on upper extremity outcomes, general physical fitness, cancer treatment-related symptoms and quality of life.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - adult females with a diagnosis of breast cancer (Stage Ic-III); - be able to participate in mild levels of activity at minimum; - have completed cancer surgery involving a mastectomy or breast conserving surgery involving either an axillary lymph node dissection or sentinel lymph node biopsy; - having completed or undergoing adjuvant chemotherapy +/- biological therapy treatment (eligible from 4 weeks to one year post-surgery at baseline); - speak and understand English. Exclusion Criteria: - unable to commit to the 10-week virtual program including testing sessions at the Cancer Rehabilitation clinic in the Corbett Hall at the University of Alberta; - do not have regular access to the internet and a smart device or computer in the home. - are scheduled to undergo neoadjuvant chemotherapy |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta/ Cross Cancer Institute | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Grip strength (optional) | Dynamometry | 10 weeks | |
Other | Core muscular endurance (optional) | Plank endurance test | 10 weeks | |
Primary | Completion rate | Defined as >70% participants completing at least 70% of exercise sessions and the post-study assessment | 10 weeks | |
Secondary | Recruitment rate | Percentage of participants eligible who consent to participate in the study | one year | |
Secondary | Attendance rate | Percentage of completed exercise and education modules | 10 weeks | |
Secondary | Program Satisfaction | Program Satisfaction Questionnaire | 10 weeks | |
Secondary | Symptoms | Edmonton Symptom Assessment System | 10 weeks | |
Secondary | Health-related Quality of Life | Functional Assessment of Cancer Therapy -breast (FACT-B+4) | 10 weeks | |
Secondary | Fatigue | Functional Assessment of Cancer Therapy - fatigue subscale (FACIT-F) | 10 weeks | |
Secondary | Physical Activity | Godin Leisure Time Exercise Questionnaire | 10 weeks | |
Secondary | Cost-effectiveness | EuroQol 5-Dimension 5-Level (EQ-5D-5L) | 10 weeks | |
Secondary | Walking endurance | Six-minute walk test | 10 weeks | |
Secondary | Lower body strength | Thirty second sit-to-stand | 10 weeks | |
Secondary | Flexibility Shoulder Flexion | Active Shoulder Range of Motion: flexion | 10 weeks | |
Secondary | Flexibility Shoulder Abduction | Active Shoulder Range of Motion: abduction | 10 weeks | |
Secondary | Flexibility Shoulder External Rotation | Active Shoulder Range of Motion: external rotation | 10 weeks | |
Secondary | Flexibility Shoulder Internal Rotation | Active Shoulder Range of Motion: internal rotation | 10 weeks | |
Secondary | Flexibility Shoulder Horizontal Abduction | Active Shoulder Range of Motion: horizontal abduction | 10 weeks | |
Secondary | Flexibility lower body | Sit-and-reach | 10 weeks | |
Secondary | Balance | One-leg Stance Test | 10 weeks | |
Secondary | Arm volume | Perometry for the measurement of lymphedema | 10 weeks | |
Secondary | Body weight | Measurement of weight in kgs | 10 weeks | |
Secondary | Body height | Measurement of height in cms | 10 weeks |
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