AzTrials
AzTrials

Breast CancerNEXT-BRCANCT04109274

Implementing Exercise Into Clinical Practice in Breast Cancer Care

A study testing Exercise, Self-Management and Booster Sessions in people with Breast Cancer, run by Hamilton Health Sciences Corporation at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Exercise, Self-Management and Booster Sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteCanada
Study dates
3 Oct 2019to 29 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

Other trials in Canada

About this study

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

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.

Read more

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
Being tested
Exercise, Self-Management, Booster Sessions
Keywords
exercise, physical activity, self-management
Medical subject headings
Breast Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    Also called Physical Activity; self-management

    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.

  • Self-ManagementBehavioural

    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 SessionsBehavioural

    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.

Study groups in NCT04109274
Study groupRoleWhat they receive
Institution-Based Exercise and Self-Management (EXSM)ExperimentalEight 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.
Receives: Behavioral: Exercise; Behavioral: Self-Management; Behavioral: Booster Sessions
Institution-Based Self-management only (SM)ExperimentalEight 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.
Receives: Behavioral: Self-Management; Behavioral: Booster Sessions
Usual careNo interventionParticipants 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'

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 16-weeks, 6-months, 12-months

Secondary outcomes (8)

  1. Change in baseline quality of life

    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).

    Measured: 16-weeks, 6-months, 12-months

  2. Change in level of exercise knowledge

    Measured using the Theory of Planned Behaviour (TPB) based questionnaire (scale range 7-56; higher scores indicate higher levels of exercise knowledge).

    Measured: 16-weeks, 6-months, 12-months

  3. Change in baseline perception of health status

    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)

    Measured: 16-weeks, 6-months, 12-months

  4. Change in baseline aerobic capacity

    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)

    Measured: 16-weeks, 6-months, 12-months

  5. Change in baseline levels of lower extremity strength

    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).

    Measured: 16-weeks, 6-months, 12-months

  6. Change in patient engagement in health services

    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).

    Measured: 16-weeks, 6-months, 12-months

  7. Change in baseline levels of resting BP

    To measure change in cardiovascular outcomes; Measured with sphygmamometer

    Measured: 16-weeks, 6-months, 12-months

  8. Change in baseline resting heart rate

    To measure change in cardiovascular outcomes; Measured with pulsed oximeter

    Measured: 16-weeks, 6-months, 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2019
  2. Study start3 Oct 2019
  3. Primary completion29 Feb 2024
  4. Study completion29 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04109274
Sponsor's protocol ID
NEXT-BRCA
Acronym
NEXT-BRCA
Status last verified
Mar 2024
First submitted
5 Sep 2019
Last updated
28 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33178447

Questions about this trial

What is this clinical trial studying?

A study testing Exercise, Self-Management and Booster Sessions in people with Breast Cancer, run by Hamilton Health Sciences Corporation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in baseline physical activity level (time frame: 16-weeks, 6-months, 12-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04109274, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in