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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Tailored Exercise Prescription

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • Leicestershire
    • Loughborough, Leicestershire, United Kingdom, LE11 3TU
      • Loughborough University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tailored Exercise Prescription; 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.	Behavioral: Tailored Exercise Prescription; 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).
No Intervention: Standard Care; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-Related Quality of Life (HRQOL)	Does the intervention result in improved HRQOL in patients undergoing systemic chemotherapy. Measured by Euro-QOL 5D.	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.	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.	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.	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.	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.	6 months.
Subjective Cognitive Function	Does the intervention result in improved subjective cognitive function in patients undergoing systemic chemotherapy. Measured by Cognitive Failures Questionnaire.	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.	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.	A Change between baseline, 3 months (post intervention), and 6 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore whether the tailored home-based exercise prescription has an effect on the concentration of circulating markers of low-grade chronic inflammation (1)	Measured plasma levels of IL-6. Measures at baseline and post-intervention.	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)	Measured plasma levels of TNF-alpha. Measures at baseline and post-intervention.	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)	Measured plasma levels of CRP. Measures at baseline and post-intervention.	A Change between baseline and 3 months (post intervention)

Collaborators and Investigators

• Sponsor: Loughborough University
• Investigators: Study Chair: Stephen Kihara, MBChB MRCP, University of Leicester NHS Trust

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Estimate): June 16, 2016
• Last Update Submitted That Met QC Criteria: June 15, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Breast Cancer; Chemotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: awaited

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No