Clinical Trial: Effectiveness and Efficiency of Physical Exercise in Cancer Patients
NCT ID: NCT01786122
Last Updated: 2014-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2013-04-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Exercise group
supervised exercise program education program on healthy habits Pharmacological treatment and selfcare encouragement
Supervised Physical activity
Both groups received standardized usual care. The EP group will receive, in addition, a nurse supervised exercise program for 2 months in the PHC and a second phase in community facilities during the remaining 10 month
education program on healthy habits
education program on healthy habits for 2 months in the PHC and a second phase in community facilities during the remaining 10 months
control group
Pharmacological treatment and selfcare encouragement.
No interventions assigned to this group
Interventions
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Supervised Physical activity
Both groups received standardized usual care. The EP group will receive, in addition, a nurse supervised exercise program for 2 months in the PHC and a second phase in community facilities during the remaining 10 month
education program on healthy habits
education program on healthy habits for 2 months in the PHC and a second phase in community facilities during the remaining 10 months
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of digestive system cancer , breast cancer or histologically confirmed NSCLC stage IV Physical Status (PS) 0 or 1.
* First-line chemotherapy treatment for each type of standard tumor
* Adequate renal, liver and blood function.
Exclusion Criteria
* Risk of fracture (bone metastases)
* Unstable heart disease, uncontrolled BP Systolic Blood Pressure((SBP)\> 200 or Diastolic Blood Pressure (DBP)\> 110), heart failure (NYHA II or greater), constrictive pericarditis
* Other diseases at the discretion of the investigator to be a contraindication for physical exercise.
* Perform regular physical activity (150 minutes / week of moderate or vigorous 75)
18 Years
70 Years
ALL
Yes
Sponsors
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Basque Health Service
OTHER_GOV
Responsible Party
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Gonzalo Grandes
Family Medicine specialist, master in epidemiology; Head of the Research Unit of Family Medicine of Bizkaia
Principal Investigators
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GRANDES GONZALO, Medicine
Role: PRINCIPAL_INVESTIGATOR
Primary Care Research Unit of Bizkaia (Basque Health Service)
ARIETALEANIZBEASCOA MARIA SOLEDAD, NURSE
Role: STUDY_DIRECTOR
Primary Care Research Unit of Bizkaia (Basque Health Service)
Locations
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Primary Care Research Unit of Bizkaia
Bilbao, Bizkaia, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Mendizabal-Gallastegui N, Arietaleanizbeaskoa MS, Latorre PM, Garcia-Alvarez A, Sancho A, Iruarrizaga E, Lopez-Vivanco G, Grandes G. Nurse-Supervised Exercise for People with Stage IV Cancer: The EFICANCER Randomized Clinical Trial. Semin Oncol Nurs. 2023 Aug;39(4):151448. doi: 10.1016/j.soncn.2023.151448. Epub 2023 May 13.
Sancho A, Carrera S, Arietaleanizbeascoa M, Arce V, Gallastegui NM, Gine March A, Sanz-Guinea A, Eskisabel A, Rodriguez AL, Martin RA, Lopez-Vivanco G, Grandes G. Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial. BMC Cancer. 2015 Feb 6;15:40. doi: 10.1186/s12885-015-1055-x.
Other Identifiers
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EFICANCER PI12/02113
Identifier Type: -
Identifier Source: org_study_id
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