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Prehabilitation for Women Undergoing Pre-operative Chemotherapy for Breast Cancer

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ClinicalTrials.gov Identifier: NCT03564171
Recruitment Status : Not yet recruiting
First Posted : June 20, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Frances Wright, Sunnybrook Health Sciences Centre

Brief Summary:
To assess recruitment rate, attrition, compliance with weekly exercise, smoking cessation, and quality of life with a multimodal prehabilitation protocol for women with breast cancer undergoing neo-adjuvant chemotherapy for breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Rehabilitation Neoadjuvant Therapy Feasibility Studies Combination Product: Prehabilitation Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: we have 2 arms, one interventional and one control, we choose them by closed envelop .
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
Estimated Study Start Date : June 25, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
No Intervention: Standard of Care
Patients will receive standard treatment without added intervention.
Experimental: 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




Primary Outcome Measures :
  1. Recruitment rate (percent reported by the research analyst ) [ Time Frame: 18 month ]
    What percent of eligible patients were successfuly recruitted in the study

  2. 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)

  3. Attrition rate (percent reported by data analysis) [ Time Frame: 18 month ]
    what percent of the patients left the study?

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. Physical activity volume [ Time Frame: 6 months ]
    How much activity the patients complete on a weekly basis

  3. Aerobic fitness (6 minute walk test) [ Time Frame: 6 months ]
    How does 6 min walk test change after intervention and treatment in both arms.

  4. Arm fitness (grip strength test) [ Time Frame: 6 months ]
    Grip strength will be assessed and compared

  5. Exercise tolerance ( FACT-An questionnair) [ Time Frame: 6 months ]
    how the patients tolerate to the exercise program



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and older, able to give consent, ECOG 0-1

Exclusion Criteria:

  • pregnant, > 75 years, medical contraindications to exercise. History of severe and persistent mental illness, cognitive impairment, recent suicide attempts or >11 on "Hospital Anxiety and Depression Scale". If very active (> 24) on the Godin-Shephard scale.

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): NCT03564171


Contacts
Contact: Frances Wright, MD 416 480 4210 ext 1053 frances.wright@sunnybrook.ca
Contact: Nasrin Alavi, md nasrin.alavi@sunnybrook.ca

Sponsors and Collaborators
Sunnybrook Health Sciences Centre
University Health Network, Toronto
Investigators
Principal Investigator: Frances Wright, MD Sunnybrook Health Sciences Centre

Responsible Party: Frances Wright, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03564171     History of Changes
Other Study ID Numbers: 041-2018
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases