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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cancer Survivors
• Stress, Psychological

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