Clinical trial NCT04109274: Implementing Exercise Into Clinical Practice in Breast Cancer Care
Official title: Evaluation of a Novel Strategy to Implement Exercise Evidence Into Clinical Practice in Breast Cancer Care: The NEXT-BRCA Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: exercise
physical activity
self-management
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Change in baseline physical activity level
timeFrame: 16-weeks, 6-months, 12-months
Secondary outcomes:
measure: Change in baseline quality of life
timeFrame: 16-weeks, 6-months, 12-months
measure: Change in level of exercise knowledge
timeFrame: 16-weeks, 6-months, 12-months
measure: Change in baseline perception of health status
timeFrame: 16-weeks, 6-months, 12-months
measure: Change in baseline aerobic capacity
timeFrame: 16-weeks, 6-months, 12-months
measure: Change in baseline levels of lower extremity strength
timeFrame: 16-weeks, 6-months, 12-months
measure: Change in patient engagement in health services
timeFrame: 16-weeks, 6-months, 12-months
measure: Change in baseline levels of resting BP
timeFrame: 16-weeks, 6-months, 12-months
measure: Change in baseline resting heart rate
timeFrame: 16-weeks, 6-months, 12-months
Other outcomes:
measure: Recruitment rate
timeFrame: At recruitment completion (approximately 1 year).
measure: Retention rate
timeFrame: At intervention completion (Approximately 1.3 years).
measure: Drop out rate throughout study
timeFrame: At study completion (2 years)
measure: Representativeness of study sample
timeFrame: At recruitment completion (approximately 1 year).
measure: Adherence rate to intervention
timeFrame: At intervention completion (Approximately 1.3 years)
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
Study officials:
References:
citation: Smith-Turchyn J, Mukherjee S, Richardson J, Ball E, Bordeleau L, Neil-Sztramko S, Levine O, Thabane L, Sathiyapalan A, Sabiston C. Evaluation of a novel strategy to implement exercise evidence into clinical practice in breast cancer care: protocol for the NEXT-BRCA randomised controlled trial. BMJ Open Sport Exerc Med. 2020 Oct 7;6(1):e000922. doi: 10.1136/bmjsem-2020-000922. eCollection 2020.