Breast CancerPhase 2NCT02468050
Study of Exercise to Manage Distress During Breast Screening
A Phase 2 study testing Moderate intensity exercise training and Self Management of exercise in people with Breast Cancer and Anxiety, run by University of Western Ontario, Canada at 1 site in Canada.
Trial summary
The breast cancer screening and diagnostic period is associated with heightened symptoms of anxiety and depression. Physical exercise has been found to effectively decrease these symptoms in healthy and diseased populations. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Breast Cancer, Anxiety, Depression
- What is being tested?
- Moderate intensity exercise training and Self Management of exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Feb 2014
- Phase
- Phase 2
- 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 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing breast biopsy at St. Joseph's Health Care, London Ontario
- minimum BI-RADS 4a
- physically inactive
Who cannot join
- meeting Health Canada Guidelines for Physical Activity for past 6 months
- medical contraindications to exercise
- unable to participate in moderate intensity exercise program
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise and Health Psychology Laboratory, Western University
London, Ontario, N6A 3K7
About this study
Official title: Effectiveness of Exercise Training and Self Management in the Attenuation of Anxiety and Depressive Symptoms Following Breast Biopsy
The breast cancer screening and diagnostic period is associated with heightened symptoms of anxiety and depression. Physical exercise has been found to effectively decrease these symptoms in healthy and diseased populations. This study aims to determine if a pre treatment exercise intervention can minimize symptoms of anxiety and depression in women undergoing screening for breast cancer.
Read the detailed description
The breast cancer diagnostic process is associated with anxiety and depression. Physical exercise has emerged as an attractive non-pharmacologic approach to mitigating the psychological and physical sequelae of breast cancer and its treatments, however pre treatment interventions are not integrated into current practice. This study aims to determine the effectiveness and feasibility of a pre treatment exercise intervention in attenuating levels of anxiety and depression following breast biopsy and throughout the diagnostic period.
- Conditions
- Breast Cancer, Anxiety, Depression
- Being tested
- Moderate intensity exercise training, Self Management of exercise
- Keywords
- Anxiety, Depression, Exercise, Breast Cancer, Biopsy, Screening, Diagnosis
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Depression, Motor Activity, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity exercise trainingBehavioural
Also called Exercise, Treatment Group 1
6 weeks of moderate intensity exercise training (50 - 75% of heart rate reserve). Sessions are facility and home based and include cardiovascular warm-up, cardiovascular training, muscular conditioning, and flexibility exercises.
Self Management of exerciseBehavioural
Also called Self Management, Self Regulation, Adherence, Treatment Group 2
In addition to the 6 week exercise program (refer to Exercise Treatment Group), participants randomly assigned to the Self Management Group will learn strategies for the self management of exercise.
| Study group | Role | What they receive |
|---|---|---|
| Self Management | Experimental | In addition to the weekly supervised exercise session, participants in this arm will view an instructional video. The video will deliver theory driven training of cognitive behavioural strategies for self management of exercise. It is expected that this will improve adherence to the exercise program. Receives: Behavioral: Moderate intensity exercise training; Behavioral: Self Management of exercise |
| Exercise | Experimental | Personalized 6 week moderate intensity (50 - 75% of heart rate reserve) facility and home based exercise program including cardiovascular and muscular conditioning. Receives: Behavioral: Moderate intensity exercise training |
| Prospective Cohort Control | No intervention | Eligible, consented participants who are unable to attend the weekly exercise sessions will serve as a cohort control group. Participants will be asked to complete patient reported measures of anxiety, depression, and exercise behaviour within 3 days of biopsy, and 6 weeks post biopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of anxiety will be assessed using patient reported anxiety inventory
Spielberger State-Trait Anxiety Inventory - State Form (STAI; Spielberger, Gorsuch, \& Lushene, 1970).
Measured: Change in baseline (within 1 week of breast biopsy) at Week 3 and at Week 6
Secondary outcomes (6)
Symptoms of subclinical depression will be assessed using a patient reported inventory
Centre for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977).
Measured: Within 1 week of breast biopsy, Week 3, Week 6
Exercise behaviour will be assessed using a patient reported inventory
Leisure Time Exercise Questionnaire (Godin \& Shephard, 1985)
Measured: Within 1 week of breast biopsy, Week 3, Week 6
Body composition: Dual X-Ray Absorptiometry scan (GE Lunar iDXA)
Measured: Baseline (within 1 week of breast biopsy), Week 6
Self Efficacy: patient reported inventory assessing efficacy for self management of exercise
Measured: 1 week post breast biopsy, Week 3, Week 6
Optimism: patient reported inventory assessing dispositional optimism
Life Orientation Test-Revised (LOT-R; Scheier, Carver, \& Bridges, 1994).
Measured: Baseline (within 1 week of core breast biopsy)
Symptoms of dispositional anxiety will be assessed using patient reported anxiety inventory
STAI - Trait Form
Measured: Within 1 week of breast biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startFeb 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muriel Brackstone, MD PhD FRCSC, Study director, London Regional Cancer ProgramAnita G Cramp, PhD, Study director, Western UniversityAmy Kossert, MHK, Study director, Western UniversityHarry Prapavessis, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468050
- Sponsor's protocol ID
- 17796
- Status last verified
- Jun 2015
- First submitted
- 25 Jun 2012
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exercise Training and Self Management in the Attenuation of Anxiety and Depressive Symptoms Following Breast Biopsy
- ClinicalTrials.gov ID
- NCT02468050
- Acronym / sponsor ID
- 17796
- Conditions
- Breast Cancer, Anxiety, Depression
- Keywords
- Anxiety, Depression, Exercise, Breast Cancer, Biopsy, Screening, Diagnosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Jun 2015 (estimated)
- 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.
The breast cancer screening and diagnostic period is associated with heightened symptoms of anxiety and depression. Physical exercise has been found to effectively decrease these symptoms in healthy and diseased populations. This study aims to determine if a pre treatment exercise intervention can minimize symptoms of anxiety and depression in women undergoing screening for breast cancer.
Detailed description
The breast cancer diagnostic process is associated with anxiety and depression. Physical exercise has emerged as an attractive non-pharmacologic approach to mitigating the psychological and physical sequelae of breast cancer and its treatments, however pre treatment interventions are not integrated into current practice. This study aims to determine the effectiveness and feasibility of a pre treatment exercise intervention in attenuating levels of anxiety and depression following breast biopsy and throughout the diagnostic period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self Management | Experimental | Behavioral: Moderate intensity exercise training, Behavioral: Self Management of exerciseIn addition to the weekly supervised exercise session, participants in this arm will view an instructional video. The video will deliver theory driven training of cognitive behavioural strategies for self management of exercise. It is expected that this will improve adherence to the exercise program. |
| Exercise | Experimental | Behavioral: Moderate intensity exercise trainingPersonalized 6 week moderate intensity (50 - 75% of heart rate reserve) facility and home based exercise program including cardiovascular and muscular conditioning. |
| Prospective Cohort Control | No intervention | –Eligible, consented participants who are unable to attend the weekly exercise sessions will serve as a cohort control group. Participants will be asked to complete patient reported measures of anxiety, depression, and exercise behaviour within 3 days of biopsy, and 6 weeks post biopsy. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing breast biopsy at St. Joseph's Health Care, London Ontario
- minimum BI-RADS 4a
- physically inactive
Key exclusion criteria (3 listed)
- meeting Health Canada Guidelines for Physical Activity for past 6 months
- medical contraindications to exercise
- unable to participate in moderate intensity exercise program
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 |
|---|---|---|
| Moderate intensity exercise trainingAlso: Exercise, Treatment Group 16 weeks of moderate intensity exercise training (50 - 75% of heart rate reserve). Sessions are facility and home based and include cardiovascular warm-up, cardiovascular training, muscular conditioning, and flexibility exercises. | Behavioural | Exercise, Self Management |
| Self Management of exerciseAlso: Self Management, Self Regulation, Adherence, Treatment Group 2In addition to the 6 week exercise program (refer to Exercise Treatment Group), participants randomly assigned to the Self Management Group will learn strategies for the self management of exercise. | Behavioural | Self Management |
Primary outcome
Symptoms of anxiety will be assessed using patient reported anxiety inventory
Time frame: Change in baseline (within 1 week of breast biopsy) at Week 3 and at Week 6
Spielberger State-Trait Anxiety Inventory - State Form (STAI; Spielberger, Gorsuch, \& Lushene, 1970).
6 secondary outcomes
Symptoms of subclinical depression will be assessed using a patient reported inventory
Time frame: Within 1 week of breast biopsy, Week 3, Week 6
Exercise behaviour will be assessed using a patient reported inventory
Time frame: Within 1 week of breast biopsy, Week 3, Week 6
Body composition: Dual X-Ray Absorptiometry scan (GE Lunar iDXA)
Time frame: Baseline (within 1 week of breast biopsy), Week 6
Self Efficacy: patient reported inventory assessing efficacy for self management of exercise
Time frame: 1 week post breast biopsy, Week 3, Week 6
Optimism: patient reported inventory assessing dispositional optimism
Time frame: Baseline (within 1 week of core breast biopsy)
Symptoms of dispositional anxiety will be assessed using patient reported anxiety inventory
Time frame: Within 1 week of breast biopsy
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 10 Jun 2015.
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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.
Muriel Brackstone, MD PhD FRCSC study director
London Regional Cancer Program
Anita G Cramp, PhD study director
Western University
Amy Kossert, MHK study director
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Moderate intensity exercise training and Self Management of exercise in people with Breast Cancer and Anxiety, run by University of Western Ontario, Canada 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 3 inclusion and 3 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 10 Jun 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Symptoms of anxiety will be assessed using patient reported anxiety inventory (time frame: Change in baseline (within 1 week of breast biopsy) at Week 3 and at Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2015.