MedDataX Logo

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

NCT ID: NCT01108484

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Survivors

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cancer survivors, exercise, diet, emotional support

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Supervised exercise

Cardiorespiratory and resistance training

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Supervised exercise: Three 90-minutes sessions per week.

Exercise + diet counseling

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

Group Type EXPERIMENTAL

Exercise + Diet counseling

Intervention Type BEHAVIORAL

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

Exercise + diet counseling + psycho 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

Group Type EXPERIMENTAL

Exercise + Diet counseling + psycho-emotional support

Intervention Type 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.

Control

They will keep their usual way of life

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise

Supervised exercise: Three 90-minutes sessions per week.

Intervention Type BEHAVIORAL

Exercise + Diet counseling

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Grupo de Investigación en Actividad Física y Salud

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fernando Herrero

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fernando Herrero-Roman, MD PhD

Role: STUDY_CHAIR

Grupo de Investigación en Actividad Física y Salud

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GIAFYS headquarters

Miranda de Ebro, Burgos, Spain

Site Status

GIAFYS

Miranda de Ebro, Burgos, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GIAFYS-2010-01

Identifier Type: -

Identifier Source: org_study_id