Behavioural Changes in Breast Cancer Patients

NCT01990430 | Unknown DMC

• 1 other identifier: behaviourchanges
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

• Patients Quality of Life Questionnaire and Exercise Leisure-time Questionnaire

  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 Outcomes (2)

• Fatigue Questionnaire

  Changes from baseline at 12 weeks

• Depression Questionnaire

  Change from baseline at 12 weeks

Other Outcomes (2)

• Physical Capacity

  Change from baseline at 12 weeks

• Maximal Strength

  Change from baseline at 12 weeks

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients will be asked to maintain their usual life style, without special changes

Interventions

Exercise Intervention BEHAVIORAL

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.

Also known as: Active Life Style

Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• in Eastern Cooperative Oncology Group (ECOG) scale (present the ability to walk briskly)
• Oncologist approval.
• Informed Consent signed.
• Comunidad Autónoma de Madrid inhabitant.

You may not qualify if:

• Metastasis presence
• Serious medical risk such as unstable cardiac condition or severe pulmonary disease and anticoagulants treatments.
• ECOG \> 1
• Pregnant

Sponsors & Collaborators

• Universidad Politecnica de Madrid: lead
• Hospital General Universitario Gregorio Marañon: collaborator
• Puerta de Hierro University Hospital: collaborator
• Hospital Universitario Madrid Sanchinarro: collaborator

Study Sites (1)

Faculty of Physical Activity and Sport Science

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (21)

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Study Officials

• Javier Sampedro, Proffesor

  Universidad Politecnica de Madrid

  STUDY DIRECTOR

Central Study Contacts

Soraya Casla, Master

CONTACT

+3491336; soraya.casla@gmail.com

Teresa Terrén, Grade

CONTACT

t.terren@gepac.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 21, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

ES (1)