Behavioural Changes in Breast Cancer Patients

NCT01990430 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-01-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hospital General Universitario Gregorio Marañon

    collaborator OTHER
  • Puerta de Hierro University Hospital

    collaborator OTHER
  • Hospital Universitario Madrid Sanchinarro

    collaborator OTHER
  • Universidad Politecnica de Madrid

    lead OTHER

Principal Investigators

  • Javier Sampedro, Proffesor · Universidad Politecnica de Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01990430 on ClinicalTrials.gov