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Program of Exercise, Diet and Control of Psychological Stress in Cancer Survivors (EDICOS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01108484
First Posted: April 22, 2010
Last Update Posted: May 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fernando Herrero, Grupo de Investigación en Actividad Física y Salud
  Purpose
A program of exercise, diet and psycho-emotional support could improve some outcomes in cancer survivors.

Condition Intervention Phase
Cancer Survivors Behavioral: Exercise Behavioral: Exercise + Diet counseling Behavioral: Exercise + Diet counseling + psycho-emotional support Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effects of Exercise, Diet and Control of Psychological Stress in Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Fernando Herrero, Grupo de Investigación en Actividad Física y Salud:

Primary Outcome Measures:
  • VO2 max [ Time Frame: basal, 6, 12 and 24 months ]
    the highest rate of oxygen consumption attainable during maximal exercise


Secondary Outcome Measures:
  • Physical Activity Quality of life Food intake Anxiety and Psychological Distress [ Time Frame: basal, 6, 12 and 24 months ]
    Measured through accelerometer, PAR, CFCA, EORTC QLQ C-30 and SF-36


Enrollment: 120
Study Start Date: March 2010
Study Completion Date: August 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supervised exercise
Cardiorespiratory and resistance training
Behavioral: Exercise
Supervised exercise: Three 90-minutes sessions per week.
Experimental: Exercise + diet counseling
Cardiorespiratory and resistance training + Diet counseling to improve food intake(more fruit and vegetable and less fat food)
Behavioral: Exercise + Diet counseling
Supervised exercise: Three 90-minutes sessions per week. Diet counseling: Counseling to balance the intake.
Experimental: Exercise + diet counseling + psycho support
Cardiorespiratory and resistance training + Diet counseling to improve food intake(more fruit and vegetable and less fat food) + Weekly sessions to modify the behaviour
Behavioral: Exercise + Diet counseling + psycho-emotional support
Supervised exercise: Three 90-minutes sessions per week. Diet counseling: Counseling to balance the intake. Psycho-emotional support: Weekly sessions to modify the behaviour.
No Intervention: Control
They will keep their usual way of life

Detailed Description:
Cancer survivors will be randomised to one of the following groups: a) Supervised physical activity, b) Supervised physical activity + Diet counseling, c) Supervised physical activity + Diet counseling + psycho-emotional support
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cancer survivors attending their follow-up visits

Exclusion Criteria:

  • Cardiac disease NYHA II
  • non-controlled hypertension
  • non-controlled metabolic disease
  • chronic infectious disease
  • non-controlled pain
  • risk of bone fracture
  • severe anemia, leucopenia or thrombopenia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108484


Locations
Spain
GIAFYS headquarters
Miranda de Ebro, Burgos, Spain, 09200
GIAFYS
Miranda de Ebro, Burgos, Spain, 09200
Sponsors and Collaborators
Grupo de Investigación en Actividad Física y Salud
Investigators
Study Chair: Fernando Herrero, MD PhD Grupo de Investigación en Actividad Física y Salud
  More Information

Responsible Party: Fernando Herrero, MD PhD, Grupo de Investigación en Actividad Física y Salud
ClinicalTrials.gov Identifier: NCT01108484     History of Changes
Other Study ID Numbers: GIAFYS-2010-01
First Submitted: April 20, 2010
First Posted: April 22, 2010
Last Update Posted: May 17, 2016
Last Verified: May 2016

Keywords provided by Fernando Herrero, Grupo de Investigación en Actividad Física y Salud:
Cancer survivors, exercise, diet, emotional support

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms