Breast CancerPhase 3STEPSNCT02802826
Studying Tailored Exercise Prescriptions in Breast Cancer Patients
A Phase 3 study testing Tailored Exercise Prescription in people with Breast Cancer, run by Loughborough University at 1 site in United Kingdom.
Trial summary
Chemotherapy forms a significant part of many breast cancer patient's treatment and is associated with various common, known adverse effects. For the last few decades, physical activity has been emerging as a viable intervention to help many of these adverse effects. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tailored Exercise Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Jan 2018
- Phase
- Phase 3
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent prior to admission to the study.
- Age 18-75 years of age.
- Able to read and speak English.
- Not currently meeting national guidelines for exercise (i.e. <150mins moderate intensity exercise on 5 or more days per week).
- Histologically confirmed diagnosis of primary breast malignancy (GROUP 1), OR Histological or radiological confirmation of advanced/metastatic breast malignancy (GROUP 2).
- Due to commence (or within 3 weeks of commencing) neo-adjuvant or adjuvant systemic chemotherapy for breast malignancy (GROUP 1), OR Due to commence (or within 3 weeks of commencing) any line of palliative systemic chemotherapy for breast malignancy (GROUP 2).
- ECOG Performance Status 0-2.
- Able (in investigator's opinion) to be able to comply with all study requirements and exercise prescription.
Who cannot join
- Any severe or uncontrolled medical conditions.
- Any unstable or uncontrolled cardiopulmonary illness.
- Recent Myocardial Infarction (<6months)
- Implanted Cardiac defibrillator.
- Uncontrolled Hypertension
- Pregnancy or <12 weeks post-partum.
Show all 11Show fewer
- Life expectancy <3 months.
- Prior history of neurological or psychiatric disorder, which could cause cognitive deficits.
- Current or planned enrolment in structured exercise or weight loss programme.
- Injury, disability or symptoms preventing compliance with exercise prescription.
- Psychological, sociological or geographical conditions that do not permit compliance with the study protocol or exercise prescription.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 3TU
Jacqueline Green, +44 (0)1509 222423, J.A.Green@lboro.ac.uk
Fehmidah Munir, BSc PhD
About this study
Official title: The Effects of a Tailored, Home-based Exercise Prescription to Increase Physical Activity in Breast Cancer Patients Undergoing Systemic Chemotherapy
Chemotherapy forms a significant part of many breast cancer patient's treatment and is associated with various common, known adverse effects. For the last few decades, physical activity has been emerging as a viable intervention to help many of these adverse effects. The study will determine if the provision of a 12-week tailored walking programme, provided alongside a home-based exercise prescription from a cancer doctor results in improved levels of physical activity and quality of life in patients with breast cancer undergoing chemotherapy.
Read the detailed description
Background Breast cancer is the most common cancer in females, with over 85% of women surviving their disease for 5 years or more. Chemotherapy forms a significant part of many patient's treatment and is associated with various common, well-characterised adverse effects. For the last few decades, physical activity has been emerging as a viable intervention to help many of the adverse effects of chemotherapy. Studies looking at patient's preferences have shown that the majority preferred walking, moderate-intensity, home-based exercise. Previous small studies have shown that cancer doctors have considerable influence on exercise behaviour; a simple recommendation significantly increased the activity levels of newly diagnosed breast cancer patients commencing treatment. A further question in the study will also assess the effect of exercise on markers of chronic inflammation in the blood. Exercise is known to reduce inflammation and this may play a significant role in cancer.
Method The study will determine if the provision of a 12-week tailored walking programme, provided alongside a home-based exercise prescription from a cancer doctor results in improved levels of physical activity in patients with breast cancer undergoing chemotherapy. Secondary objectives will assess patient-reported activity, quality-of-life, completion rates of chemotherapy, cognitive function, anxiety and depression levels, body composition as well as exploring the role of the effects on specific markers of chronic inflammation in the blood.
The investigators will recruit 100 patients from LRI undergoing chemotherapy for breast cancer. Participants will be allocated to either the intervention or a standard care group in this study. Those in the intervention group will receive the walking programme with various motivational strategies incorporated as well as a discussion on the benefits of exercise and a prescription from the cancer team. Those in the standard care will not receive the intervention material. All women will wear wrist accelerometers (to measure activity levels) before and after the 12-week period and complete assessments at these points (as well as a further follow up assessment at 6 months). Assessments will include study questionnaires, cognitive testing, measurements of body fat and blood tests.
Potential impact The investigators aim to show that the intervention will result in significantly improved levels of physical activity, as well as improved quality of life and improvements in other secondary outcome measures. They also predict that the intervention will result in a significant lowering of inflammatory marker concentration when compared to standard care. The study will provide an important addition to the evidence that exists for cancer teams to encourage patients and survivors to meet national physical activity guidelines. In the longer term, the intervention being tested in the proposed study has the potential to be an inexpensive and sustainable addition to the standard care provided to cancer patients and this will hopefully lead to a larger-scale national study.
- Conditions
- Breast Cancer
- Being tested
- Tailored Exercise Prescription
- Keywords
- Exercise, Chemotherapy, Physical Activity, Breast Cancer
- 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.
Tailored Exercise PrescriptionBehavioural
The intervention is a walking- based exercise prescription with the aim of a graduated increase in exercise to achieve national guidelines (i.e. Over 150mins of moderate intensity exercise over a week).
| Study group | Role | What they receive |
|---|---|---|
| Tailored Exercise Prescription | Experimental | Participants will have a discussion on the 'My Exercise Prescription' booklet on the benefits of increasing levels of physical activity. They will be encouraged to read this in more detail and guided through its completion. The participant will receive an exercise prescription using the Pre-Intervention Assessment Tool (PIAT) and following discussion with the participant on a realistic and achievable starting point.
The booklets provided will guide participants through the exercise programme which is a graduated walking-based activity intervention. Both booklets provide participants with a suggested starting point for walking distance per week based on their PIAT score as well as motivational and behaviour change strategies to encourage participation. Receives: Behavioral: Tailored Exercise Prescription |
| Standard Care | No intervention | No sham or placebo conditions will be used in the study. At visit 1 standard care participants will be given the Standard Care Information Sheet and asked to simply continue with standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Moderate-Vigorous Physical Activity
To determine whether tailored home-based exercise prescriptions results in a change in Physical Activity (objectively measured) in patients with breast cancer undergoing systemic chemotherapy. Measured by accelerometer.
Measured: A Change between baseline and 3 months (post intervention)
Secondary outcomes (9)
Health-Related Quality of Life (HRQOL)
Does the intervention result in improved HRQOL in patients undergoing systemic chemotherapy. Measured by Euro-QOL 5D.
Measured: A Change between baseline, 3 months (post intervention), and 6 months.
Health-Related Quality of Life (HRQOL) 2
Does the intervention result in improved HRQOL in patients undergoing systemic chemotherapy. Measured by EORTC QLQ C30.
Measured: A Change between baseline, 3 months (post intervention), and 6 months.
Subjectively measured physical activity
Does the intervention result in improved Subjectively measured physical activity in patients undergoing systemic chemotherapy. Measured by International Physical Activity Questionnaire.
Measured: A Change between baseline, 3 months (post intervention), and 6 months.
Sitting time
Does the intervention result in improved sitting time in patients undergoing systemic chemotherapy. Measured by International Physical Activity Questionnaire.
Measured: Baseline, 3 months (post intervention) & 6 months
Alteration in Stage of Motivational Readiness to Change
Does the intervention result in improved Stage of Motivational Readiness to Change in patients undergoing systemic chemotherapy. Measured by Stages of Change Questionnaire.
Measured: A Change between baseline, 3 months (post intervention), and 6 months.
Completion rate of Systemic Chemotherapy
Does the intervention result in improved chemotherapy completion in patients undergoing systemic chemotherapy. Measured by data collected on completion rate of chemotherapy.
Measured: 6 months.
Subjective Cognitive Function
Does the intervention result in improved subjective cognitive function in patients undergoing systemic chemotherapy. Measured by Cognitive Failures Questionnaire.
Measured: A Change between baseline, 3 months (post intervention), and 6 months.
Objective Cognitive Function
Does the intervention result in improved objective cognitive function in patients undergoing systemic chemotherapy. Measured by objective cognitive testing.
Measured: A Change between baseline, 3 months (post intervention), and 6 months.
Body Composition
Does the intervention result in favourable changes in body composition with an increase in lean body mass (LBM) and a reduction in body fat percentage (BFP) in patients undergoing systemic chemotherapy. Measured by Bioelectrical Impedance Analysis.
Measured: A Change between baseline, 3 months (post intervention), and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2017 (estimated)
- Study completionJan 2018 (estimated)
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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Stephen Kihara, Loughborough University
- Investigators
- Stephen Kihara, MBChB MRCP, Study chair, University of Leicester NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802826
- Sponsor's protocol ID
- Awaited
- Acronym
- STEPS
- Status last verified
- Jun 2016
- First submitted
- 23 May 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Tailored, Home-based Exercise Prescription to Increase Physical Activity in Breast Cancer Patients Undergoing Systemic Chemotherapy
- ClinicalTrials.gov ID
- NCT02802826
- Acronym / sponsor ID
- STEPS / Awaited
- Conditions
- Breast Cancer
- Keywords
- Exercise, Chemotherapy, Physical Activity, Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 16 Jun 2016 (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.
Chemotherapy forms a significant part of many breast cancer patient's treatment and is associated with various common, known adverse effects. For the last few decades, physical activity has been emerging as a viable intervention to help many of these adverse effects. The study will determine if the provision of a 12-week tailored walking programme, provided alongside a home-based exercise prescription from a cancer doctor results in improved levels of physical activity and quality of life in patients with breast cancer undergoing chemotherapy.
Detailed description
Background Breast cancer is the most common cancer in females, with over 85% of women surviving their disease for 5 years or more. Chemotherapy forms a significant part of many patient's treatment and is associated with various common, well-characterised adverse effects. For the last few decades, physical activity has been emerging as a viable intervention to help many of the adverse effects of chemotherapy. Studies looking at patient's preferences have shown that the majority preferred walking, moderate-intensity, home-based exercise. Previous small studies have shown that cancer doctors have considerable influence on exercise behaviour; a simple recommendation significantly increased the activity levels of newly diagnosed breast cancer patients commencing treatment. A further question in the study will also assess the effect of exercise on markers of chronic inflammation in the blood. Exercise is known to reduce inflammation and this may play a significant role in cancer.
Method The study will determine if the provision of a 12-week tailored walking programme, provided alongside a home-based exercise prescription from a cancer doctor results in improved levels of physical activity in patients with breast cancer undergoing chemotherapy. Secondary objectives will assess patient-reported activity, quality-of-life, completion rates of chemotherapy, cognitive function, anxiety and depression levels, body composition as well as exploring the role of the effects on specific markers of chronic inflammation in the blood.
The investigators will recruit 100 patients from LRI undergoing chemotherapy for breast cancer. Participants will be allocated to either the intervention or a standard care group in this study. Those in the intervention group will receive the walking programme with various motivational strategies incorporated as well as a discussion on the benefits of exercise and a prescription from the cancer team. Those in the standard care will not receive the intervention material. All women will wear wrist accelerometers (to measure activity levels) before and after the 12-week period and complete assessments at these points (as well as a further follow up assessment at 6 months). Assessments will include study questionnaires, cognitive testing, measurements of body fat and blood tests.
Potential impact The investigators aim to show that the intervention will result in significantly improved levels of physical activity, as well as improved quality of life and improvements in other secondary outcome measures. They also predict that the intervention will result in a significant lowering of inflammatory marker concentration when compared to standard care. The study will provide an important addition to the evidence that exists for cancer teams to encourage patients and survivors to meet national physical activity guidelines. In the longer term, the intervention being tested in the proposed study has the potential to be an inexpensive and sustainable addition to the standard care provided to cancer patients and this will hopefully lead to a larger-scale national study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored Exercise Prescription | Experimental | Behavioral: Tailored Exercise PrescriptionParticipants will have a discussion on the 'My Exercise Prescription' booklet on the benefits of increasing levels of physical activity. They will be encouraged to read this in more detail and guided through its completion. The participant will receive an exercise prescription using the Pre-Intervention Assessment Tool (PIAT) and following discussion with the participant on a realistic and achievable starting point. The booklets provided will guide participants through the exercise programme which is a graduated walking-based activity intervention. Both booklets provide participants with a suggested starting point for walking distance per week based on their PIAT score as well as motivational and behaviour change strategies to encourage participation. |
| Standard Care | No intervention | –No sham or placebo conditions will be used in the study. At visit 1 standard care participants will be given the Standard Care Information Sheet and asked to simply continue with standard care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent prior to admission to the study.
- Age 18-75 years of age.
- Able to read and speak English.
- Not currently meeting national guidelines for exercise (i.e. <150mins moderate intensity exercise on 5 or more days per week).
- Histologically confirmed diagnosis of primary breast malignancy (GROUP 1), OR Histological or radiological confirmation of advanced/metastatic breast malignancy (GROUP 2).
Key exclusion criteria (11 listed)
- Any severe or uncontrolled medical conditions.
- Any unstable or uncontrolled cardiopulmonary illness.
- Recent Myocardial Infarction (<6months)
- Implanted Cardiac defibrillator.
- Uncontrolled Hypertension
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 |
|---|---|---|
| Tailored Exercise PrescriptionThe intervention is a walking- based exercise prescription with the aim of a graduated increase in exercise to achieve national guidelines (i.e. Over 150mins of moderate intensity exercise over a week). | Behavioural | Tailored Exercise Prescription |
Primary outcome
Level of Moderate-Vigorous Physical Activity
Time frame: A Change between baseline and 3 months (post intervention)
To determine whether tailored home-based exercise prescriptions results in a change in Physical Activity (objectively measured) in patients with breast cancer undergoing systemic chemotherapy. Measured by accelerometer.
9 secondary outcomes
Health-Related Quality of Life (HRQOL)
Time frame: A Change between baseline, 3 months (post intervention), and 6 months.
Health-Related Quality of Life (HRQOL) 2
Time frame: A Change between baseline, 3 months (post intervention), and 6 months.
Subjectively measured physical activity
Time frame: A Change between baseline, 3 months (post intervention), and 6 months.
Sitting time
Time frame: Baseline, 3 months (post intervention) & 6 months
Alteration in Stage of Motivational Readiness to Change
Time frame: A Change between baseline, 3 months (post intervention), and 6 months.
Completion rate of Systemic Chemotherapy
Time frame: 6 months.
Subjective Cognitive Function
Time frame: A Change between baseline, 3 months (post intervention), and 6 months.
Objective Cognitive Function
Time frame: A Change between baseline, 3 months (post intervention), and 6 months.
Body Composition
Time frame: A Change between baseline, 3 months (post intervention), and 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Stephen Kihara, MBChB MRCP study chair
University of Leicester NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tailored Exercise Prescription in people with Breast Cancer, run by Loughborough University at 1 site in United Kingdom.
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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Jun 2016. 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 United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Kihara, MBChB (+44 (0) 7730609777, s.kihara@lboro.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Moderate-Vigorous Physical Activity (time frame: A Change between baseline and 3 months (post intervention)). 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 16 Jun 2016.