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

Not Applicable

Completed

• Conditions: Cancer Survivors
• Interventions: Behavioral: Exercise; Behavioral: Exercise + Diet counseling; Behavioral: Exercise + Diet counseling + psycho-emotional support

• Registration Number: NCT01108484
• Lead Sponsor: Grupo de Investigación en Actividad Física y Salud

Brief Summary

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

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 Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-04-20
• Study First Posted: 2010-04-22
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-26
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised exercise	Exercise	Cardiorespiratory and resistance training
Exercise + diet counseling	Exercise + Diet counseling	Cardiorespiratory and resistance training + Diet counseling to improve food intake(more fruit and vegetable and less fat food)
Exercise + diet counseling + psycho support	Exercise + Diet counseling + psycho-emotional 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

Primary Outcome Measures

Name	Time	Method
VO2 max	basal, 6, 12 and 24 months	the highest rate of oxygen consumption attainable during maximal exercise

Secondary Outcome Measures

Name	Time	Method
Physical Activity Quality of life Food intake Anxiety and Psychological Distress	basal, 6, 12 and 24 months	Measured through accelerometer, PAR, CFCA, EORTC QLQ C-30 and SF-36

Trial Locations

Locations (2)

GIAFYS headquarters; 🇪🇸 Miranda de Ebro, Burgos, Spain

GIAFYS; 🇪🇸 Miranda de Ebro, Burgos, Spain