Program of Exercise, Diet and Control of Psychological Stress in Cancer Survivors
EDICOS
Evaluation of the Effects of Exercise, Diet and Control of Psychological Stress in Cancer Survivors
1 other identifier
interventional
140
1 country
2
Brief Summary
A program of exercise, diet and psycho-emotional support could improve some outcomes in cancer survivors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2010
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 20, 2010
CompletedFirst Posted
Study publicly available on registry
April 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedNovember 30, 2020
November 1, 2020
5.3 years
April 20, 2010
November 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VO2 max
the highest rate of oxygen consumption attainable during maximal exercise
basal, 6, 12 and 24 months
Secondary Outcomes (1)
Physical Activity Quality of life Food intake Anxiety and Psychological Distress
basal, 6, 12 and 24 months
Study Arms (4)
Supervised exercise
EXPERIMENTALCardiorespiratory and resistance training
Exercise + diet counseling
EXPERIMENTALCardiorespiratory and resistance training + Diet counseling to improve food intake(more fruit and vegetable and less fat food)
Exercise + diet counseling + psycho support
EXPERIMENTALCardiorespiratory and resistance training + Diet counseling to improve food intake(more fruit and vegetable and less fat food) + Weekly sessions to modify the behaviour
Control
NO INTERVENTIONThey will keep their usual way of life
Interventions
Supervised exercise: Three 90-minutes sessions per week. Diet counseling: Counseling to balance the intake.
Supervised exercise: Three 90-minutes sessions per week. Diet counseling: Counseling to balance the intake. Psycho-emotional support: Weekly sessions to modify the behaviour.
Eligibility Criteria
You may qualify if:
- cancer survivors attending their follow-up visits
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
GIAFYS headquarters
Miranda de Ebro, Burgos, 09200, Spain
GIAFYS
Miranda de Ebro, Burgos, 09200, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fernando Herrero-Roman, MD PhD
Grupo de Investigación en Actividad Física y Salud
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
April 20, 2010
First Posted
April 22, 2010
Study Start
March 1, 2010
Primary Completion
July 1, 2015
Study Completion
August 1, 2015
Last Updated
November 30, 2020
Record last verified: 2020-11