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

Hamilton Health Sciences (HHS)

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Exercise; Behavioral: Booster Sessions; Behavioral: Self-Management

Study type: Interventional

Funder types: Other

Identifiers

NCT04109274

NEXT-BRCA

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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85 participants in 3 patient groups

Institution-Based Exercise and Self-Management (EXSM)

Experimental group

Description:

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.

Treatment:

Behavioral: Self-Management

Behavioral: Exercise

Behavioral: Booster Sessions

Institution-Based Self-management only (SM)

Experimental group

Description:

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.

Treatment:

Behavioral: Self-Management

Behavioral: Booster Sessions

Usual care

No Intervention group

Description:

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'