Prehabilitation for Women Undergoing Pre-operative Chemotherapy for Breast Cancer
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03564171|
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : February 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Rehabilitation Neoadjuvant Therapy Feasibility Studies||Combination Product: Prehabilitation||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||2 arms: Intervention and control (chosen by closed envelope, 1:1 randomization)|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Controlled Feasibility Study Comparing a Multimodal Prehabilitation Protocol to Normal Care for Women Undergoing Neo-adjuvant Chemotherapy for Breast Cancer|
|Actual Study Start Date :||July 18, 2018|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2021|
No Intervention: Standard of Care
Patients will receive standard treatment without added intervention.
These patients will receive standard treatment plus multimodal intervention (prehabilitation program) including :
exercise, nutritional counseling, stress counseling, smoking cessation) before starting chemotherapy.
Combination Product: Prehabilitation
stress counseling, exercise, nutritional counseling, smoking cessation counseling
- Recruitment rate (percent reported by the research analyst ) [ Time Frame: 18 month ]What percent of eligible patients were successfuly recruitted in the study
- Exercise compliance rate (percent reported by analysis of data) [ Time Frame: 18 month ]number of exercise sessions per week and mean compliance rate (percent of the prescribed exercises within sessions)
- Attrition rate (percent reported by data analysis) [ Time Frame: 18 month ]what percent of the patients left the study?
- Stress consultation compliance rate (percent reported by data analyst) [ Time Frame: 18 months ]Percent of the patients that have satisfaction with counseling and use of education meterials that are provided to them.
- Quality of life (FACT-B questionnair) [ Time Frame: 18 months ]The Functional Assessment of Cancer Therapy - Breast (FACT-B) is a validated quality of life scale for breast cancer survivors capturing subdomains of physical, social, emotional, and functional well-being as well as specific concerns for breast cancer. The FACT-An, a validated fatigue scale for cancer survivors, the PROMIS which looks at cognitive functioning will be used.
- Physical activity volume [ Time Frame: 6 months ]How much activity the patients complete on a weekly basis
- Aerobic fitness (6 minute walk test) [ Time Frame: 6 months ]How does 6 min walk test change after intervention and treatment in both arms.
- Arm fitness (grip strength test) [ Time Frame: 6 months ]Grip strength will be assessed and compared
- Exercise tolerance ( FACT-An questionnair) [ Time Frame: 6 months ]how the patients tolerate to the exercise program
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): NCT03564171
|Contact: Frances Wright, MD||416 480 4210 ext firstname.lastname@example.org|
|Contact: Apisha Sriemail@example.com|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N3M5|
|Contact: Frances c wright, MD|
|Principal Investigator:||Frances Wright, MD||Sunnybrook Health Sciences Centre|