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

November 26, 2020 updated by: Fernando Herrero, Grupo de Investigación en Actividad Física y Salud

Evaluation of the Effects of Exercise, Diet and Control of Psychological Stress in Cancer Survivors

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO2 max
Time Frame: basal, 6, 12 and 24 months
the highest rate of oxygen consumption attainable during maximal exercise
basal, 6, 12 and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
basal, 6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Investigación en Actividad Física y Salud

Investigators

  • Study Chair: Fernando Herrero-Roman, MD PhD, Grupo de Investigación en Actividad Física y Salud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 22, 2010

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 26, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIAFYS-2010-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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