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NCT01108484 Clinical Trial

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

Cancer Survivors Clinical Trial

— EDICOS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01108484
Other study ID # GIAFYS-2010-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2010
Est. completion date August 2015

Study information
Verified date November 2020
Source Grupo de Investigación en Actividad Física y Salud
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date August 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Exercise
Supervised exercise: Three 90-minutes sessions per week.
• Exercise + Diet counseling
Supervised exercise: Three 90-minutes sessions per week. Diet counseling: Counseling to balance the intake.
• 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.

Locations
Country Name City State
Spain GIAFYS Miranda de Ebro Burgos
Spain GIAFYS headquarters Miranda de Ebro Burgos

Sponsors (1)
Lead Sponsor Collaborator
Grupo de Investigación en Actividad Física y Salud

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary VO2 max the highest rate of oxygen consumption attainable during maximal exercise basal, 6, 12 and 24 months
Secondary Physical Activity Quality of life Food intake Anxiety and Psychological Distress Measured through accelerometer, PAR, CFCA, EORTC QLQ C-30 and SF-36 basal, 6, 12 and 24 months
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