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

Study Overview
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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.

Official Title
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PHYSICAL EXERCISE TO IMPROVE THE QUALITY OF LIFE OF CANCER PATIENTS DURING TREATMENT PROCESS: EFICANCER STUDY

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

Intervention / Treatment
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* Other: Supervised Physical activity
* Behavioral: education program on healthy habits


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>supervised exercise program education program on healthy habits Pharmacological treatment and selfcare encouragement | Other: Supervised Physical activity<br>* 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<br>Behavioral: education program on healthy habits<br>* education program on healthy habits for 2 months in the PHC and a second phase in community facilities during the remaining 10 months<br>|
| No Intervention: control group<br>Pharmacological treatment and selfcare encouragement. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Health Related Quality of Life (EORTC QLQ-C30) |  | basal,2,6,12 months fllow up | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical exercise, Health Related Quality of Life, Non-Small-Cell Lung Carcinoma, digestive system neoplasms, breast neoplasms