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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fernando Herrero, Grupo de Investigación en Actividad Física y Salud
ClinicalTrials.gov Identifier:
NCT01108484
First received: April 20, 2010
Last updated: May 10, 2015
Last verified: May 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Grupo de Investigación en Actividad Física y Salud:

Primary Outcome Measures:
  • VO2 max [ Time Frame: basal, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured through accelerometer, PAR, CFCA, EORTC QLQ C-30 and SF-36


Estimated Enrollment: 120
Study Start Date: March 2010
Estimated Study Completion Date: August 2015
Estimated 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: Ex + 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108484

Locations
Spain
GIAFYS
Miranda de Ebro, Burgos, Spain, 09200
GIAFYS headquarters
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

No publications provided

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
Study First Received: April 20, 2010
Last Updated: May 10, 2015
Health Authority: Spain: Ethics Committee

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

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 03, 2015