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

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

Detailed Description
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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

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

Conditions
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Cancer Survivors

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Exercise + Diet counseling
* Behavioral: Exercise + Diet counseling + psycho-emotional support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised exercise<br>Cardiorespiratory and resistance training | Behavioral: Exercise<br>* Supervised exercise: Three 90-minutes sessions per week.<br>|
| Experimental: Exercise + diet counseling<br>Cardiorespiratory and resistance training + Diet counseling to improve food intake(more fruit and vegetable and less fat food) | Behavioral: Exercise + Diet counseling<br>* Supervised exercise: Three 90-minutes sessions per week. Diet counseling: Counseling to balance the intake.<br>|
| Experimental: Exercise + diet counseling + psycho support<br>Cardiorespiratory and resistance training + Diet counseling to improve food intake(more fruit and vegetable and less fat food) + Weekly sessions to modify the behaviour | Behavioral: Exercise + Diet counseling + psycho-emotional support<br>* Supervised exercise: Three 90-minutes sessions per week. Diet counseling: Counseling to balance the intake. Psycho-emotional support: Weekly sessions to modify the behaviour.<br>|
| No Intervention: Control<br>They will keep their usual way of life | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2 max | 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 | Measured through accelerometer, PAR, CFCA, EORTC QLQ C-30 and SF-36 | basal, 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer survivors, exercise, diet, emotional support