Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Implementing Exercise Into Clinical Practice in Breast Cancer Care (NEXT-BRCA)

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: NCT04109274
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation

Brief Summary:

BACKGROUND:

One in eight women will develop breast cancer in their lifetime. With improved screening and treatment techniques, more women are surviving breast cancer. However, women live with physical and emotional side effects secondary to treatment for years after cancer treatments have ended. Exercise can help to manage these side effects, however, less than 30% of this population takes part in regular exercise. The objective of this trial is to determine the feasibility and effectiveness of a novel exercise and education program for women with breast cancer during chemotherapy.

METHODS:

Participants in this study include women with a diagnosis of stage 1 - 3 breast cancer undergoing chemotherapy. Women will be divided into three groups. The first group will include 8 sessions of exercise and self-management education during their chemotherapy treatment. The second group will receive self-management education only, and the third group will receive usual care. Outcomes will be compared between groups at baseline, post-intervention, and at 6- and 12- month follow up. Outcomes to be assessed include exercise level, functional mobility, muscle strength, quality of life, health status, and use of health care services.

EXPECTED OUTCOMES:

Women with breast cancer are among the least active segment of the Canadian population. It is well known that inactivity can lead to physical and psychological side effects, cancer recurrence, and an increase in comorbid conditions. This proposed project addresses a long-standing need to help women with breast cancer become and stay more active by implementing a novel exercise and education program.


Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Exercise Behavioral: Self-Management Behavioral: Booster Sessions Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Novel Strategy to Implement Exercise Evidence Into Clinical Practice in Breast Cancer Care: The NEXT-BRCA Trial
Actual Study Start Date : October 3, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Institution-Based Exercise and Self-Management (EXSM)
Eight session of supervised exercise within the cancer institution plus 8 self-management modules focusing on goal setting and action planning for safe and effective exercise strategies (this is based on our team's successful pilot intervention). Four booster sessions will be provided to this group.
Behavioral: Exercise
Exercise component: Aerobic exercise, using recumbent bikes, delivered within the cancer institution. Participants will take part in up to 30-minutes of moderate intensity (50-70% HRmax or 4-6/10 on Rate of Perceived Exertion scale)6 exercise for eight sessions during chemotherapy. An exercise specialist with experience in cancer rehabilitation will supervise the exercise component.
Other Name: Physical Activity; self-management

Behavioral: Self-Management
Eight SM modules will be delivered to participants. They will be viewed on an iPad prior to or after the exercise component. The goal of these modules is to aid participants in developing physical activity goals and action plans to continue with between sessions, with an overarching goal of helping them reach exercise guidelines for cancer survivors and the Canadian Physical Activity Guidelines

Behavioral: Booster Sessions
Four booster sessions will be provided to participants in this group. These will occur at 2, 4, 6, and 8 months post intervention completion. An assessor trained in behavioural counselling will provide booster sessions by phone and will discuss the individuals physical and emotional condition, current exercise level, accomplishment of previously set goals and action plans, and perceived barriers to participation in exercise. The assessor will use facilitation strategies to aid participants in devising strategies to overcome barriers and set realistic goals and action plans.

Experimental: Institution-Based Self-management only (SM)
Eight SM sessions for safe and effective exercise strategies will be provided to this group (described above). Four booster sessions will be provided to this group.
Behavioral: Self-Management
Eight SM modules will be delivered to participants. They will be viewed on an iPad prior to or after the exercise component. The goal of these modules is to aid participants in developing physical activity goals and action plans to continue with between sessions, with an overarching goal of helping them reach exercise guidelines for cancer survivors and the Canadian Physical Activity Guidelines

Behavioral: Booster Sessions
Four booster sessions will be provided to participants in this group. These will occur at 2, 4, 6, and 8 months post intervention completion. An assessor trained in behavioural counselling will provide booster sessions by phone and will discuss the individuals physical and emotional condition, current exercise level, accomplishment of previously set goals and action plans, and perceived barriers to participation in exercise. The assessor will use facilitation strategies to aid participants in devising strategies to overcome barriers and set realistic goals and action plans.

No Intervention: Usual care
Participants in this group will receive care as normally provided by their treating oncologist. This can be heterogeneous between different physicians and centres, but usually includes oncologists encouraging their patients to 'stay active'



Primary Outcome Measures :
  1. Change in baseline physical activity level [ Time Frame: 16-weeks, 6-months, 12-months ]
    To be assessed using the Godin Leisure Time Exercise Questionnaire (total score 0-no maximum; higher scores indicating higher levels of physical activity) and activity tracker (Fitbit) data (demonstrating steps/day and total time of moderate levels of physical activity; higher scores indicate higher levels of activity).


Secondary Outcome Measures :
  1. Change in baseline quality of life [ Time Frame: 16-weeks, 6-months, 12-months ]
    Measured using the Functional Assessment of Cancer Therapy-Breast (measure of quality of life in breast cancer survivors; scale range 0-144; higher scores indicate higher levels of quality of life).

  2. Change in level of exercise knowledge [ Time Frame: 16-weeks, 6-months, 12-months ]
    Measured using the Theory of Planned Behaviour (TPB) based questionnaire (scale range 7-56; higher scores indicate higher levels of exercise knowledge).

  3. Change in baseline perception of health status [ Time Frame: 16-weeks, 6-months, 12-months ]
    Measured using the EQ-5D-3L a measure of health status (has two systems; a 3 level scale assessing five dimensions of health and a visual analogue scale from 0-10; higher scores indicate higher perceptions of health status)

  4. Change in baseline aerobic capacity [ Time Frame: 16-weeks, 6-months, 12-months ]
    Measured using the Six-minute walk test (6MWT) (a performance based measure that assesses total distance walked in six minutes, higher scores indicate higher levels of aerobic capacity)

  5. Change in baseline levels of lower extremity strength [ Time Frame: 16-weeks, 6-months, 12-months ]
    Measured using a manual muscle dynamometer (Movements assessed will be isometric hip and knee flexion/extension and ankle plantar flexion/dorsiflexion; higher scores indicate higher levels of lower extremity strength).

  6. Change in patient engagement in health services [ Time Frame: 16-weeks, 6-months, 12-months ]
    Measured using the Patient Health Engagement Scale (assesses five domains related to the experiences and preferences of patients for their engagement with their health care treatment; score range from 5-35; higher scores indicate higher levels of patient engagement in health services).

  7. Change in baseline levels of resting BP [ Time Frame: 16-weeks, 6-months, 12-months ]
    To measure change in cardiovascular outcomes; Measured with sphygmamometer

  8. Change in baseline resting heart rate [ Time Frame: 16-weeks, 6-months, 12-months ]
    To measure change in cardiovascular outcomes; Measured with pulsed oximeter


Other Outcome Measures:
  1. Recruitment rate [ Time Frame: At recruitment completion (approximately 1 year). ]
    Percentage of eligible patients actually enrolled in the study.

  2. Retention rate [ Time Frame: At intervention completion (Approximately 1.3 years). ]
    Percentage of enrolled patients who complete the intervention.

  3. Drop out rate throughout study [ Time Frame: At study completion (2 years) ]
    Percentage of participants who drop out from study at any time.

  4. Representativeness of study sample [ Time Frame: At recruitment completion (approximately 1 year). ]
    Descriptive characteristics of study samples (in regard to characteristics such as age, stage of cancer, fitness level, socio-economic status, etc.)

  5. Adherence rate to intervention [ Time Frame: At intervention completion (Approximately 1.3 years) ]
    Percentage of total intervention sessions attended.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • community-dwelling
  • English-speaking women
  • over 18 years of age
  • currently undergoing adjuvant or neoadjuvant chemotherapy for Stage 1-3 breast cancer
  • cleared by their oncologist to participate in moderate intensity aerobic exercise

Exclusion Criteria:

  • self-report any chronic condition, cognitive impairment, or injury that would prevent them from participating independently in moderate intensity exercise

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): NCT04109274


Contacts
Layout table for location contacts
Contact: Jenna Smith-Turchyn, PT, PhD 905-869-0599 smithjf@mcmaster.ca
Contact: Som Mukherjee, MD 905-387-9711 ext 63123 mukherjee@hhsc.ca

Locations
Layout table for location information
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Som Mukjerjee, MD    905-387-9711 ext 63123    mukherjee@hhsc.ca   
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT04109274    
Other Study ID Numbers: NEXT-BRCA
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hamilton Health Sciences Corporation:
exercise
physical activity
self-management
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases