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Completed

NCT Number: NCT04109274

Implementing Exercise Into Clinical Practice in Breast Cancer Care

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Physical Activity; self-management

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

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study title

Evaluation of a Novel Strategy to Implement Exercise Evidence Into Clinical Practice in Breast Cancer Care: The NEXT-BRCA Trial

Acronym: NEXT-BRCA

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 30, 2019
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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