Behavioural Changes in Breast Cancer Patients (BHVBC)

January 12, 2014 updated by: Soraya Casla Barrio, Universidad Politecnica de Madrid

Integrative Exercise and Life Style Intervention Increase Leisure Time Activity in Breast Cancer Patients.

Exercise training has been established as a feasible and safe intervention during or after neoplastic treatment in breast cancer patients. Numerous studies have shown that exercise can prevent and control various treatment-related side effects including functional limitation, physical capacity, anxiety and sleep disturbance. In the long-term, an active life style has been demonstrated to increase survival in women, who maintain a moderate level of exercise per week (30 or 75 minutes of brisk walking 5 days per week).

Specifically, active breast cancer survivors have a 51-85% lower cancer specific mortality and 33-82% lower all cause of mortality. But despite this, most breast cancer patients reduce their physical activity levels during and after cancer treatment. In 2010, a roundtable meeting of American College of Sport Medicine published guidelines for cancer survivors, defining that the recommended amount of exercise was 150 minutes per week of aerobic exercise of moderate-intensity and 2 or 3 days per week of strength training that included exercise for major muscle groups. But only 30-47% of breast cancer survivors follow these exercise recommendations.

In most clinical settings, information by the oncologist to keep physical active is part of the recommendation. Yet some breast cancer patients find it difficult to begin or maintain the minimal activity levels recommended by the experts. A typical obstacle includes lack of directions from experts, which can assure the safety and feasibility of the exercise that they perform. Moreover, important personal aspects can have major influence on the exercise preference, including certain food choice and dietary intakes, education level or the preference of a face-to-face exercise counseling by a professional.

A cancer diagnosis is recognized as "teachable moment", where patients are particularly motivated for lifestyle changes. So it is important to approach the patients with adequate interventions that consider the different needs in order to get a healthier behavior among the breast cancer patients.

Taking this into account, the hypothesis of this pilot project is that a guided integrated group exercise program, which includes an educational program on healthy life style, will increase the adherence of breast cancer survivors to exercise and a healthy diet. Therefore the aim of this pilot study was to investigate if a comprehensive and specific group exercise program, which includes dietary and exercise information, could increase leisure-time exercise in women with breast cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study will be performed as a collaboration between Technical University of Madrid (UPM), Spanish Group of Cancer Patients (GEPAC), Hospital General Universitario Gregorio Marañón, Hospital Universitario Puerta de Hierr y Hospital de Sanchinarro-Madrid del Norte. The project will be carried out at the facilities of the Physical Activity and Sport Science Institute (INEF) and has been approved by the Ethical Committee of the UPM. A single arm pilot project with pre-post test has been designed.

Intervention The exercise program was designed and conducted by a qualified exercise physiologist with oncologic training. The exercise program consisted in a twice weekly supervised training program developed in a social framework. The sessions included instructions in training exercises, as well as included time to speak about their fears and doubts with other patients, who were in the same situation. The intervention lasted 12 weeks (24 sessions). The training intensity was progressively increased from 65% to 85% of heart rate with control by a POLAR FT7 heart rate monitor for aerobic activities, and by 8-15 repetitions in 2-3 sets for the strength activities. Exercise intensity was prescribed using Karvonen equation.

Every supervised session had the same structure and a duration of 60 minutes. American College Sport Medicine (ACSM) Guidelines for Cancer Patients were followed for the session design. The first 10 minutes was a dynamic warm up combining different ways of movement around the class and articular movements. Next part consisted in aerobic exercise, where the principal aim was to practice exercises that increased the participant's functional capacity with music-based activities such as aerobic, box-dance or global strength circuits without external resistance. Followed by upper-limbs strength exercises with elastic bands to improve strength and increase arm lean mass, focusing on chest and dorsal exercises. The last part was whole-body stretching exercises to improve joint mobility and muscle flexibility of upper body limbs, and general muscle relaxation after training.

The exercise program was complemented with theoretical classes about exercise and nutrition. One class of exercise prescription was held after two months of intervention. The patients were taught about the minimum of exercise recommended and about which activities they could do and how to adapt them depending on their own situations.

The nutrition program consisted of three theoretical and practice classes, where specific terms of nutrition and diet were explained. The first class explained the different groups of nutrients, their functions in the organism and for which group of aliments these can be obtained. The second class was a practical class about how to interpret food labels and relating measurements of food portions with recommendations for a healthy diet. Final session spoke about the ten best and the ten worst aliments, which prevent and promote cancer. Teachers did not promote avoiding any group of aliments and a Mediterranean diet was encouraged to be followed.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Faculty of Physical Activity and Sport Science
        • Contact:
        • Principal Investigator:
          • Soraya Casla, Master
        • Sub-Investigator:
          • Ruben O Barakat, PhD
        • Sub-Investigator:
          • Sara Lopez-Tarruella, PhD, MD
        • Sub-Investigator:
          • Ivan Márquez, PhD, MD
        • Sub-Investigator:
          • Miguel Martín, PhD, MD
        • Sub-Investigator:
          • Yolanda Jerez, MD
        • Sub-Investigator:
          • Ricardo Cubedo, MD
        • Sub-Investigator:
          • Isabel Calvo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Inclusion criteria:

  • Older than 18 years and younger than 75.
  • Breast cancer diagnosed confirmed stage I-IIIA.
  • Randomized disposition.
  • Minimum of 45 days and maximum of 36 months after finishing treatments (chemotherapy and radiotherapy).
  • 0-1 in Eastern Cooperative Oncology Group (ECOG) scale (present the ability to walk briskly)
  • Oncologist approval.
  • Informed Consent signed.
  • Comunidad Autónoma de Madrid inhabitant.

Exclusion Criteria:

  • Metastasis presence
  • Serious medical risk such as unstable cardiac condition or severe pulmonary disease and anticoagulants treatments.
  • Oncology or primary care approval who verified the medical risk exclusion criteria.
  • ECOG > 1
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Intervention

The exercise program was designed and conducted by a qualified exercise physiologist with oncologic training. The exercise program consisted in a twice weekly supervised training program developed in a social framework. The sessions included instructions in training exercises, as well as included time to speak about their fears and doubts with other patients, who were in the same situation.

The nutrition program consisted of three theoretical and practice classes, where specific terms of nutrition and diet were explained. Teachers did not promote avoiding any group of aliments and a Mediterranean diet was encouraged to be followed.
Behavioral: Exercise Intervention

Intervention: The sessions included instructions in training exercises, as well as included time to speak about their fears and doubts with other patients, who were in the same situation. The intervention lasted 12 weeks (24 sessions). The training intensity was progressively increased from 65% to 85% of heart rate with control by a POLAR FT7 heart rate monitor for aerobic activities, and by 8-15 repetitions in 2-3 sets for the strength activities. Exercise intensity was prescribed using Karvonen equation.

The nutrition program consisted of three theoretical and practice classes. The first class explained the different groups of nutrients, their functions in the organism and for which group of aliments these can be obtained. The second class was a practical class about how to interpret food labels and relating measurements of food portions with recommendations for a healthy diet. Final session spoke about the ten best and the ten worst aliments, which prevent and promote cancer.

Other Names:
  • Active Life Style
No Intervention: Control
Patients will be asked to maintain their usual life style, without special changes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients Quality of Life Questionnaire and Exercise Leisure-time Questionnaire
Time Frame: Changes from baseline at 12 weeks
Combined primary objective has been elected. Both of them have to be positive. FACT-B and Godin Leisure-Time Exercise Questionnaire have been chosen as validated instruments to assess primary variables
Changes from baseline at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Questionnaire
Time Frame: Changes from baseline at 12 weeks
Fact-Fatigue (FACT-F) is the instrument chose to assess the variable
Changes from baseline at 12 weeks
Depression Questionnaire
Time Frame: Change from baseline at 12 weeks
Center of Epidemiologic Studies Depression Scale (CES-D scale) is the validated questioner chose to assess this variable
Change from baseline at 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Capacity
Time Frame: Change from baseline at 12 weeks
A maximal oxigen consumption (VO2) test will be used to assess this variable
Change from baseline at 12 weeks
Maximal Strength
Time Frame: Change from baseline at 12 weeks
A 1 maximal repetition will be used to assess this variable
Change from baseline at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Politecnica de Madrid

Collaborators

Hospital General Universitario Gregorio Marañon
Puerta de Hierro University Hospital
Hospital Universitario Madrid Sanchinarro

Investigators

  • Study Director: Javier Sampedro, Proffesor, Universidad Politécnica de Madrid.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

October 25, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 12, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • behaviourchanges

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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