Cancer SurvivorsEDICOSNCT01108484
Program of Exercise, Diet and Control of Psychological Stress in Cancer Survivors
A study testing Exercise, Exercise + Diet counseling and Exercise + Diet counseling + psycho-emotional support in people with Cancer Survivors, run by Grupo de Investigación en Actividad Física y Salud at 2 sites in Spain.
Trial summary
A program of exercise, diet and psycho-emotional support could improve some outcomes in cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- Exercise, Exercise + Diet counseling and Exercise + Diet counseling + psycho-emotional support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesSpain
- Study dates
- Mar 2010to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cancer survivors attending their follow-up visits
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
GIAFYS headquarters
Miranda de Ebro, Burgos, 09200
GIAFYS
Miranda de Ebro, Burgos, 09200
About this study
Official title: Evaluation of the Effects of Exercise, Diet and Control of Psychological Stress in Cancer Survivors
A program of exercise, diet and psycho-emotional support could improve some outcomes in cancer survivors.
Read the 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
- Conditions
- Cancer Survivors
- Being tested
- Exercise, Exercise + Diet counseling, Exercise + Diet counseling + psycho-emotional support
- Keywords
- Cancer survivors, exercise, diet, emotional support
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Supervised exercise: Three 90-minutes sessions per week.
Exercise + Diet counselingBehavioural
Supervised exercise: Three 90-minutes sessions per week. Diet counseling: Counseling to balance the intake.
Exercise + Diet counseling + psycho-emotional supportBehavioural
Supervised exercise: Three 90-minutes sessions per week. Diet counseling: Counseling to balance the intake. Psycho-emotional support: Weekly sessions to modify the behaviour.
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise | Experimental | Cardiorespiratory and resistance training Receives: Behavioral: Exercise |
| Exercise + diet counseling | Experimental | Cardiorespiratory and resistance training + Diet counseling to improve food intake(more fruit and vegetable and less fat food) Receives: Behavioral: Exercise + Diet counseling |
| Exercise + diet counseling + psycho support | Experimental | Cardiorespiratory and resistance training + Diet counseling to improve food intake(more fruit and vegetable and less fat food) + Weekly sessions to modify the behaviour Receives: Behavioral: Exercise + Diet counseling + psycho-emotional support |
| Control | No intervention | They will keep their usual way of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 max
the highest rate of oxygen consumption attainable during maximal exercise
Measured: basal, 6, 12 and 24 months
Secondary outcomes (1)
Physical Activity Quality of life Food intake Anxiety and Psychological Distress
Measured through accelerometer, PAR, CFCA, EORTC QLQ C-30 and SF-36
Measured: basal, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de Investigación en Actividad Física y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Herrero, Grupo de Investigación en Actividad Física y Salud
- Investigators
- Fernando Herrero-Roman, MD PhD, Study chair, Grupo de Investigación en Actividad Física y Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108484
- Sponsor's protocol ID
- GIAFYS-2010-01
- Acronym
- EDICOS
- Status last verified
- Nov 2020
- First submitted
- 20 Apr 2010
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Exercise, Diet and Control of Psychological Stress in Cancer Survivors
- ClinicalTrials.gov ID
- NCT01108484
- Acronym / sponsor ID
- EDICOS / GIAFYS-2010-01
- Conditions
- Cancer Survivors
- Keywords
- Cancer survivors, exercise, diet, emotional support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Grupo de Investigación en Actividad Física y SaludUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise | Experimental | Behavioral: ExerciseCardiorespiratory and resistance training |
| Exercise + diet counseling | Experimental | Behavioral: Exercise + Diet counselingCardiorespiratory and resistance training + Diet counseling to improve food intake(more fruit and vegetable and less fat food) |
| Exercise + diet counseling + psycho support | Experimental | Behavioral: Exercise + Diet counseling + psycho-emotional supportCardiorespiratory and resistance training + Diet counseling to improve food intake(more fruit and vegetable and less fat food) + Weekly sessions to modify the behaviour |
| Control | No intervention | –They will keep their usual way of life |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- cancer survivors attending their follow-up visits
Key exclusion criteria (7 listed)
- Cardiac disease NYHA II
- non-controlled hypertension
- non-controlled metabolic disease
- chronic infectious disease
- non-controlled pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseSupervised exercise: Three 90-minutes sessions per week. | Behavioural | Supervised exercise |
| Exercise + Diet counselingSupervised exercise: Three 90-minutes sessions per week. Diet counseling: Counseling to balance the intake. | Behavioural | Exercise + diet counseling |
| Exercise + Diet counseling + psycho-emotional supportSupervised exercise: Three 90-minutes sessions per week. Diet counseling: Counseling to balance the intake. Psycho-emotional support: Weekly sessions to modify the behaviour. | Behavioural | Exercise + diet counseling + psycho support |
Primary outcome
VO2 max
Time frame: basal, 6, 12 and 24 months
the highest rate of oxygen consumption attainable during maximal exercise
1 secondary outcome
Physical Activity Quality of life Food intake Anxiety and Psychological Distress
Time frame: basal, 6, 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Herrero-Roman, MD PhD study chair
Grupo de Investigación en Actividad Física y Salud
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Exercise + Diet counseling and Exercise + Diet counseling + psycho-emotional support in people with Cancer Survivors, run by Grupo de Investigación en Actividad Física y Salud at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 max (time frame: basal, 6, 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.