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

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ClinicalTrials.gov Identifier: NCT01108484
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Fernando Herrero, Grupo de Investigación en Actividad Física y Salud

Brief Summary:
A program of exercise, diet and psycho-emotional support could improve some outcomes in cancer survivors.

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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
Study Start Date : March 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


Secondary Outcome Measures :
  1. 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



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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

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

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 Posted: April 22, 2010    Key Record Dates
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