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Completed

NCT Number: NCT01108484

Program 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.

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Key information

Conditions

Cancer Survivors Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GIAFYS, Miranda de Ebro, Burgos, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Supervised exercise: Three 90-minutes sessions per week.

Exercise + Diet counseling

Behavioral

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

Exercise + Diet counseling + psycho-emotional support

Behavioral

Supervised exercise: Three 90-minutes sessions per week. Diet counseling: Counseling to balance the intake. Psycho-emotional support: Weekly sessions to modify the behaviour.

Primary outcomes

  1. VO2 max

    Time frame: basal, 6, 12 and 24 months

    the highest rate of oxygen consumption attainable during maximal exercise

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Grupo de Investigación en Actividad Física y Salud

Other

Registry information

Official study title

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

Acronym: EDICOS

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Apr 22, 2010
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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