Studying Tailored Exercise Prescriptions in Breast Cancer Patients
STEPS
The Effects of a Tailored, Home-based Exercise Prescription to Increase Physical Activity in Breast Cancer Patients Undergoing Systemic Chemotherapy
1 other identifier
interventional
100
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Jul 2016
Shorter than P25 for phase_3 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedJune 16, 2016
June 1, 2016
1.3 years
May 23, 2016
June 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
A Change between baseline and 3 months (post intervention)
Secondary Outcomes (9)
Health-Related Quality of Life (HRQOL)
A Change between baseline, 3 months (post intervention), and 6 months.
Health-Related Quality of Life (HRQOL) 2
A Change between baseline, 3 months (post intervention), and 6 months.
Subjectively measured physical activity
A Change between baseline, 3 months (post intervention), and 6 months.
Sitting time
Baseline, 3 months (post intervention) & 6 months
Alteration in Stage of Motivational Readiness to Change
A Change between baseline, 3 months (post intervention), and 6 months.
- +4 more secondary outcomes
Other Outcomes (3)
To explore whether the tailored home-based exercise prescription has an effect on the concentration of circulating markers of low-grade chronic inflammation (1)
A Change between baseline and 3 months (post intervention)
To explore whether the tailored home-based exercise prescription has an effect on the concentration of circulating markers of low-grade chronic inflammation (2)
A Change between baseline and 3 months (post intervention)
To explore whether the tailored home-based exercise prescription has an effect on the concentration of circulating markers of low-grade chronic inflammation (3)
A Change between baseline and 3 months (post intervention)
Study Arms (2)
Tailored Exercise Prescription
EXPERIMENTALParticipants 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 INTERVENTIONNo 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loughborough University
Loughborough, Leicestershire, LE11 3TU, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Stephen Kihara, MBChB MRCP
University of Leicester NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Investigator
Study Record Dates
First Submitted
May 23, 2016
First Posted
June 16, 2016
Study Start
July 1, 2016
Primary Completion
October 1, 2017
Study Completion
January 1, 2018
Last Updated
June 16, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share