Clinical Trial: Effectiveness and Efficiency of Physical Exercise in Cancer Patients

NCT ID: NCT01786122

Last Updated: 2014-07-23

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-12-31

Brief Summary

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AIM: To evaluate the effectiveness and efficiency of an innovative exercise program (EP) for patients during treatment for gastrointestinal tumors, breast and non small cells lung cancer, in terms of improved quality of life (QOL), fatigue and functional capacity respect the usual standard treatment (ST). DESIGN: Pragmatic randomized clinical trial in two parallel groups: EP and ST. SETTING: 7 Primary Health Centers (PHC) of the redIAPPISCIII, in coordination with oncology services. PARTICIPANTS: 250 patients with the above tumors, locally advanced or with metastatic disease, in adjuvant treatment, with Performance Status(PS) PS1-PS0. INTERVENTION: 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 months. MEASUREMENTS: The primary outcome measure is the change from baseline in the QOL+66 treatment, as measured by the specific questionnaire for patients with cancer EORTC QLQ-C-30 and Short Form(SF-36) overall. Secondary: fatigue (FACIT-F), radiological response, functional capacity (6 minutes walking and cardiopulmonary test), muscle strength and progression-free survival and overall. Predictors and confounders: age, sex, stage and tumor type, histology, treatment. ANALYSIS: We will compare between groups mean changes from baseline measurement of quality of life questionnaire (QOL) and other variables, on an intention to treat basis, using longitudinal mixed-effects models for repeated measures at 2, 6 and 12 months follow-up. Cost / effectiveness and cost / incremental utility associated to the program wil be estimated.

Detailed Description

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Conditions

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Non-Small-Cell Lung Carcinoma Digestive System Neoplasms Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise group

supervised exercise program education program on healthy habits Pharmacological treatment and selfcare encouragement

Group Type EXPERIMENTAL

Supervised Physical activity

Intervention Type OTHER

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

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

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

Intervention Type OTHER

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age between 18-70 years
* 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

* Brain metastases
* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Basque Health Service

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gonzalo Grandes

Family Medicine specialist, master in epidemiology; Head of the Research Unit of Family Medicine of Bizkaia

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Gonzalo Grandes, Medicine

Role: CONTACT

0034946006637

Maria Soledad Arietaleanisbeaskoa, Nurse

Role: CONTACT

0034946006637

Facility Contacts

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ARIETALEANIZBEASCOA MARISOL, NURSE

Role: primary

946006637

ARCE ARANA, NURSE

Role: backup

946006637

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.

Reference Type DERIVED
PMID: 37183104 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25655792 (View on PubMed)

Other Identifiers

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EFICANCER PI12/02113

Identifier Type: -

Identifier Source: org_study_id

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