Studying Tailored Exercise Prescriptions in Breast Cancer Patients

Breast Cancer Clinical Trial

— STEPS  

Official title:

The Effects of a Tailored, Home-based Exercise Prescription to Increase Physical Activity in Breast Cancer Patients Undergoing Systemic Chemotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02802826
• Other study ID #: Awaited
• Status: Not yet recruiting
• Phase: Phase 3
• First received: May 23, 2016
• Last updated: June 15, 2016
• Start date: July 2016
• Est. completion date: January 2018

Study information

• Verified date: June 2016
• Source: Loughborough University
• Contact: Stephen Kihara, MBChB
• Phone: +44 (0) 7730609777
• Email: s.kihara[@]lboro.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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).

Locations

Country	Name	City	State
United Kingdom	Loughborough University	Loughborough	Leicestershire

Sponsors (1)

Lead Sponsor	Collaborator
Loughborough University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	No
Other	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)	No
Other	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)	No
Primary	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)	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No