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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental | supervised exercise program education program on healthy habits Pharmacological treatment and selfcare encouragement |
|
| control group | No Intervention | Pharmacological treatment and selfcare encouragement. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised Physical activity | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Health Related Quality of Life (EORTC QLQ-C30) | basal,2,6,12 months fllow up |
| Measure | Description | Time Frame |
|---|---|---|
| asthenia measurement with FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionaire | Basal, 2,6 and12 months | |
| Functional Capacity-6 minute Walking test | basal, 2,6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gonzalo Grandes, Medicine | Contact | 0034946006637 | GONZALO.GRANDESODRIOZOLA@osakidetza.net | |
| Maria Soledad Arietaleanisbeaskoa, Nurse | Contact | 0034946006637 | MARIASOLEDAD.ARIETALEANIZBEASCOASARABIA@osakidetza.net |
| Name | Affiliation | Role |
|---|---|---|
| GRANDES GONZALO, Medicine | Primary Care Research Unit of Bizkaia (Basque Health Service) | Principal Investigator |
| ARIETALEANIZBEASCOA MARIA SOLEDAD, NURSE | Primary Care Research Unit of Bizkaia (Basque Health Service) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Care Research Unit of Bizkaia | Recruiting | Bilbao | Bizkaia | 48014 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37183104 | Derived | 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. | |
| 25655792 |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D004067 | Digestive System Neoplasms |
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| education program on healthy habits | Behavioral | education program on healthy habits for 2 months in the PHC and a second phase in community facilities during the remaining 10 months |
|
| cardiorespiratory test | basal, 2, 6 and12 months |
| Changes in Muscular Strenght-Dynamometer | basal, 2,6 nad 12 months |
| progression-free survival | basal, 2, 6 and 12 months |
| 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. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004066 | Digestive System Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |