Breast CancerNCT03087461
Bridging the Gap: Incorporating Exercise Evidence Into Clinical Practice in Breast Cancer Care in Ontario
A study testing Exercise and self-management in people with Breast Cancer, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Breast cancer (BC) and its treatments lead to numerous side effects that affect a person's life for years after treatment has ended. Research shows that regular exercise limits many of these side effects. 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 and self-management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2017to 1 Oct 2018
- 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, who are currently undergoing chemotherapy for Stage 1-3 BC and have been cleared by their oncologist to participate in moderate intensity aerobic exercise
Who cannot join
- Participants will be excluded from the study if they have another chronic disease, cognitive impairment or injury that prevents them from participating independently in moderate intensity exercise
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer (BC) and its treatments lead to numerous side effects that affect a person's life for years after treatment has ended. Research shows that regular exercise limits many of these side effects. However, less than 30% of BC survivors regularly exercise due to many barriers that include patients being unaware of the benefits of exercise, health professionals facing institutional, personal, and patient-related barriers to promoting exercise, and a lack of knowledge translation (KT) strategies within cancer institutions that focus on accessible exercise interventions and education by physiotherapists. For this project, a pilot study is needed as the first step in order to assess process and resource variables before implementation of a large-scale intervention.
The primary objective of this pilot trial is to assess the feasibility of conducting a larger trial to evaluate the effects of a novel KT intervention using exercise and self-management versus usual care among BC survivors. The secondary objective is to determine preliminary estimates of effects of the KT intervention of exercise plus self-management (SM) program versus usual care on (a) levels of exercise knowledge and behaviour, (b) health related quality of life and (c) resource utilization, among BC survivors over a four month period.
Read the detailed description
Study Design: Pilot randomized controlled trial. Eligibility: Women older than 18 years who are currently undergoing chemotherapy treatment for BC.
Intervention: The intervention group includes an 8-session multi-component intervention with a structured aerobic exercise program plus SM supervised by a physiotherapist.
Setting: Outpatient-Juravinski Cancer Centre in Hamilton, ON. Control: Usual care. Randomization: Participants will be randomly allocated using a 1:1 allocation ratio to receive the intervention of structured exercise plus SM program or usual care.
Sample size: The study will recruit n=12 number of participants/group for a total of 24 in both groups.
Analysis: A blinded assessor will assess outcomes at baseline, post intervention, at 2- and 4-month follow up. Intervention feasibility and effectiveness will be assessed using descriptive statistics and analysis of covariance for continuous outcomes.
Anticipated Impact: This study aims to assess the feasibility of a larger trial to determine effective ways to close the current KT gap and increase exercise awareness for women with BC. This project will assess process and resource variables before implementation of a larger scale intervention. Together, the overall project goal is to promote sustainable exercise behaviour to help manage the burden of BC.
- Conditions
- Breast Cancer
- Being tested
- Exercise and self-management
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and self-managementBehavioural
The intervention will include aerobic exercise and self-management education using technology.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will receive a multi-component KT intervention. This will include exercise and self-management components.
The exercise intervention will involve a moderate intensity aerobic exercise program, using recumbent bikes, delivered within the cancer institution. Participants will take part in the 30-minute sessions 8 times. The intervention will be supervised by a physiotherapist (PT) educated in cancer rehabilitation.
The SM component will include educational modules created by a PT. Participants will view these 30 minute modules prior to each exercise intervention, over the same 8 sessions. Receives: Behavioral: Exercise and self-management |
| Usual Care | No intervention | Control group receiving usual care (no exercise or self-management education within the institution). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Recruitment Rate: percentage of eligible patients recruited
A recruitment log will be kept, detailing reasons for non-participation.
Measured: Baseline
Intervention Retention Rate: percentage of consented participants who completed the intervention
Attendance will be tracked on the feasibility data collection sheet and reasons for non-participation on scheduled intervention days will be documented using an adherence log
Measured: Post-intervention (2 months post baseline)
Intervention Adherence Rate: percentage of total intervention sessions attended
Attendance will be tracked on the feasibility data collection sheet and reasons for non-participation on scheduled intervention days will be documented using an adherence log
Measured: Post-intervention (2 months post baseline)
Secondary outcomes (6)
Health related quality of life
Functional Assessment of Cancer Therapy-Breast
Measured: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Exercise knowledge
Theory of planned behaviour questionnaire
Measured: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Exercise behaviour
Theory of planned behaviour questionnaire
Measured: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Health status
European Quality of Life-Five Dimension (EQ-5D)
Measured: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Use of health care services
Piloted form assessing doctor visits, procedures, medication use, missed days of work
Measured: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Physical Activity Level
Godin Leisure Time Physical Activity Questionnaire
Measured: Baseline, post intervention, 2 and 4 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start1 Jun 2017
- Primary completion1 Mar 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenna Smith, Hamilton Health Sciences Corporation
- Investigators
- Jenna Smith-Turchyn, PT, PhD(c), Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087461
- Sponsor's protocol ID
- HamiltonHSC-JS
- Status last verified
- Feb 2019
- First submitted
- 7 Mar 2017
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith-Turchyn J, Richardson J, Tozer R, McNeely M, Thabane L. Bridging the gap: incorporating exercise evidence into clinical practice in breast cancer care. Support Care Cancer. 2020 Feb;28(2):897-905. doi: 10.1007/s00520-019-04897-9. Epub 2019 Jun 5.
PubMed 31168711
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging the Gap: Incorporating Exercise Evidence Into Clinical Practice in Breast Cancer Care in Ontario
- ClinicalTrials.gov ID
- NCT03087461
- Acronym / sponsor ID
- HamiltonHSC-JS
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer (BC) and its treatments lead to numerous side effects that affect a person's life for years after treatment has ended. Research shows that regular exercise limits many of these side effects. However, less than 30% of BC survivors regularly exercise due to many barriers that include patients being unaware of the benefits of exercise, health professionals facing institutional, personal, and patient-related barriers to promoting exercise, and a lack of knowledge translation (KT) strategies within cancer institutions that focus on accessible exercise interventions and education by physiotherapists. For this project, a pilot study is needed as the first step in order to assess process and resource variables before implementation of a large-scale intervention.
The primary objective of this pilot trial is to assess the feasibility of conducting a larger trial to evaluate the effects of a novel KT intervention using exercise and self-management versus usual care among BC survivors. The secondary objective is to determine preliminary estimates of effects of the KT intervention of exercise plus self-management (SM) program versus usual care on (a) levels of exercise knowledge and behaviour, (b) health related quality of life and (c) resource utilization, among BC survivors over a four month period.
Detailed description
Study Design: Pilot randomized controlled trial. Eligibility: Women older than 18 years who are currently undergoing chemotherapy treatment for BC.
Intervention: The intervention group includes an 8-session multi-component intervention with a structured aerobic exercise program plus SM supervised by a physiotherapist.
Setting: Outpatient-Juravinski Cancer Centre in Hamilton, ON. Control: Usual care. Randomization: Participants will be randomly allocated using a 1:1 allocation ratio to receive the intervention of structured exercise plus SM program or usual care.
Sample size: The study will recruit n=12 number of participants/group for a total of 24 in both groups.
Analysis: A blinded assessor will assess outcomes at baseline, post intervention, at 2- and 4-month follow up. Intervention feasibility and effectiveness will be assessed using descriptive statistics and analysis of covariance for continuous outcomes.
Anticipated Impact: This study aims to assess the feasibility of a larger trial to determine effective ways to close the current KT gap and increase exercise awareness for women with BC. This project will assess process and resource variables before implementation of a larger scale intervention. Together, the overall project goal is to promote sustainable exercise behaviour to help manage the burden of BC.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Exercise and self-managementThe intervention group will receive a multi-component KT intervention. This will include exercise and self-management components. The exercise intervention will involve a moderate intensity aerobic exercise program, using recumbent bikes, delivered within the cancer institution. Participants will take part in the 30-minute sessions 8 times. The intervention will be supervised by a physiotherapist (PT) educated in cancer rehabilitation. The SM component will include educational modules created by a PT. Participants will view these 30 minute modules prior to each exercise intervention, over the same 8 sessions. |
| Usual Care | No intervention | –Control group receiving usual care (no exercise or self-management education within the institution). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Community-dwelling, English-speaking women, over 18 years, who are currently undergoing chemotherapy for Stage 1-3 BC and have been cleared by their oncologist to participate in moderate intensity aerobic exercise
Key exclusion criteria (1 listed)
- Participants will be excluded from the study if they have another chronic disease, cognitive impairment or injury that prevents them from participating independently in moderate intensity exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and self-managementThe intervention will include aerobic exercise and self-management education using technology. | Behavioural | Intervention Group |
Primary outcome
Study Recruitment Rate: percentage of eligible patients recruited
Time frame: Baseline
A recruitment log will be kept, detailing reasons for non-participation.
Intervention Retention Rate: percentage of consented participants who completed the intervention
Time frame: Post-intervention (2 months post baseline)
Attendance will be tracked on the feasibility data collection sheet and reasons for non-participation on scheduled intervention days will be documented using an adherence log
Intervention Adherence Rate: percentage of total intervention sessions attended
Time frame: Post-intervention (2 months post baseline)
Attendance will be tracked on the feasibility data collection sheet and reasons for non-participation on scheduled intervention days will be documented using an adherence log
6 secondary outcomes
Health related quality of life
Time frame: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Exercise knowledge
Time frame: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Exercise behaviour
Time frame: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Health status
Time frame: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Use of health care services
Time frame: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Physical Activity Level
Time frame: Baseline, post intervention, 2 and 4 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Derived from this study: PubMed 31168711Smith-Turchyn J, Richardson J, Tozer R, McNeely M, Thabane L. Bridging the gap: incorporating exercise evidence into clinical practice in breast cancer care. Support Care Cancer. 2020 Feb;28(2):897-905. doi: 10.1007/s00520-019-04897-9. Epub 2019 Jun 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenna Smith-Turchyn, PT, PhD(c) principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and self-management 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 1 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 22 Feb 2019. 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?
Study Recruitment Rate: percentage of eligible patients recruited (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT03087461, 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 22 Feb 2019.