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

Primary Purpose

Cancer Survivors

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise
Exercise + Diet counseling
Exercise + Diet counseling + psycho-emotional support
Sponsored by
Grupo de Investigación en Actividad Física y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Survivors focused on measuring Cancer survivors, exercise, diet, emotional support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GIAFYS headquarters
  • GIAFYS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Supervised exercise

Exercise + diet counseling

Exercise + diet counseling + psycho support

Control

Arm Description

Cardiorespiratory and resistance training

Cardiorespiratory and resistance training + Diet counseling to improve food intake(more fruit and vegetable and less fat food)

Cardiorespiratory and resistance training + Diet counseling to improve food intake(more fruit and vegetable and less fat food) + Weekly sessions to modify the behaviour

They will keep their usual way of life

Outcomes

Primary Outcome Measures

VO2 max
the highest rate of oxygen consumption attainable during maximal exercise

Secondary Outcome Measures

Physical Activity Quality of life Food intake Anxiety and Psychological Distress
Measured through accelerometer, PAR, CFCA, EORTC QLQ C-30 and SF-36

Full Information

First Posted
April 20, 2010
Last Updated
November 26, 2020
Sponsor
Grupo de Investigación en Actividad Física y Salud
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1. Study Identification

Unique Protocol Identification Number
NCT01108484
Brief Title
Program of Exercise, Diet and Control of Psychological Stress in Cancer Survivors
Acronym
EDICOS
Official Title
Evaluation of the Effects of Exercise, Diet and Control of Psychological Stress in Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grupo de Investigación en Actividad Física y Salud

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivors
Keywords
Cancer survivors, exercise, diet, emotional support

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised exercise
Arm Type
Experimental
Arm Description
Cardiorespiratory and resistance training
Arm Title
Exercise + diet counseling
Arm Type
Experimental
Arm Description
Cardiorespiratory and resistance training + Diet counseling to improve food intake(more fruit and vegetable and less fat food)
Arm Title
Exercise + diet counseling + psycho support
Arm Type
Experimental
Arm Description
Cardiorespiratory and resistance training + Diet counseling to improve food intake(more fruit and vegetable and less fat food) + Weekly sessions to modify the behaviour
Arm Title
Control
Arm Type
No Intervention
Arm Description
They will keep their usual way of life
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Supervised exercise: Three 90-minutes sessions per week.
Intervention Type
Behavioral
Intervention Name(s)
Exercise + Diet counseling
Intervention Description
Supervised exercise: Three 90-minutes sessions per week. Diet counseling: Counseling to balance the intake.
Intervention Type
Behavioral
Intervention Name(s)
Exercise + Diet counseling + psycho-emotional support
Intervention Description
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 Outcome Measure Information:
Title
VO2 max
Description
the highest rate of oxygen consumption attainable during maximal exercise
Time Frame
basal, 6, 12 and 24 months
Secondary Outcome Measure Information:
Title
Physical Activity Quality of life Food intake Anxiety and Psychological Distress
Description
Measured through accelerometer, PAR, CFCA, EORTC QLQ C-30 and SF-36
Time Frame
basal, 6, 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Herrero-Roman, MD PhD
Organizational Affiliation
Grupo de Investigación en Actividad Física y Salud
Official's Role
Study Chair
Facility Information:
Facility Name
GIAFYS headquarters
City
Miranda de Ebro
State/Province
Burgos
ZIP/Postal Code
09200
Country
Spain
Facility Name
GIAFYS
City
Miranda de Ebro
State/Province
Burgos
ZIP/Postal Code
09200
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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