Implementing Exercise Into Clinical Practice in Breast Cancer Care

NCT04109274 | Completed

• 1 other identifier: NEXT-BRCA
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

exercise; physical activity; self-management

Outcome Measures

Primary Outcomes (1)

• Change in baseline physical activity level

  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).

  16-weeks, 6-months, 12-months

Secondary Outcomes (8)

• Change in baseline quality of life

  16-weeks, 6-months, 12-months

• Change in level of exercise knowledge

  16-weeks, 6-months, 12-months

• Change in baseline perception of health status

  16-weeks, 6-months, 12-months

• Change in baseline aerobic capacity

  16-weeks, 6-months, 12-months

• Change in baseline levels of lower extremity strength

  16-weeks, 6-months, 12-months

Other Outcomes (5)

• Recruitment rate

  At recruitment completion (approximately 1 year).

• Retention rate

  At intervention completion (Approximately 1.3 years).

• Drop out rate throughout study

  At study completion (2 years)

Study Arms (3)

Institution-Based Exercise and Self-Management (EXSM)

EXPERIMENTAL

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; Behavioral: Self-Management; Behavioral: Booster Sessions

Institution-Based Self-management only (SM)

EXPERIMENTAL

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; Behavioral: Booster Sessions

Usual care

NO INTERVENTION

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'

Interventions

Exercise BEHAVIORAL

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.

Also known as: Physical Activity; self-management

Institution-Based Exercise and Self-Management (EXSM)

Self-Management BEHAVIORAL

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

Institution-Based Exercise and Self-Management (EXSM); Institution-Based Self-management only (SM)

Booster Sessions BEHAVIORAL

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.

Institution-Based Exercise and Self-Management (EXSM); Institution-Based Self-management only (SM)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Related Publications (1)

• 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.

  PMID: 33178447 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Exercise; Self-Management

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 30, 2019
• Study Start: October 3, 2019
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)