- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01108484
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
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
-
-
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
|
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)
|
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
|
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.
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
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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