BIZI ORAIN: Exercise for All People With Cancer

Study Overview
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Brief Summary
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Background: Physical exercise should be an essential component of the therapeutic plan for every person diagnosed with cancer. However, most of these patients are inactive and only a few of them receive prescription and follow-up for safe and effective exercise plans. Objective: in a first experimental phase, we will evaluate actual implementation (reach and adherence) and clinical effectiveness (physical fitness, quality of life and symptoms) of the BIZI ORAIN (BO) exercise program, for all patients diagnosed with cancer, compared to standardized physical activity counseling. In a second, observational phase, we will evaluate the association between levels of physical activity actually performed by all the participants and their 12 months evolution, in terms of physical fitness, quality of life, symptomatology and survival. Design: Hybrid study, with a first experimental phase in which patients diagnosed with cancer will be randomly assigned to two parallel groups, one that immediately performs the BO program for 12 weeks and the other one that performs the same programme three months later (delayed treatment). In the second phase, observational, the entire cohort of participants will be followed-up for one year. Population: Any person diagnosed with cancer in the previous two years (minimum sample size = 1013) free of bone metastases, hematological or other exercise contraindications. BIZI ORAIN program: based on the Life Now program of the Australian Cancer Council, BO is a 12-week small-group exercise program supervised by specially trained instructors combining moderate to high intensity aerobic and strength exercises (three 1 hour sessions a week). Outcome measurements: the main outcome variable will be the change in functional capacity at three months (400 meters walk test). Secondary variables include mortality, quality of life (general SF-36 and cancer specific quality of life -European Organization for Research and Treatment of Cancer QLQ-C-30-), symptoms (Cancer-related fatigue - Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), exposure to physical activity level objectively registered with Actigraph wGT3X-BT accelerometer, chronic inflammation (C-reactive protein, adiponectin, and pro-inflammatory cytokines Il-1, Il-6 , and TNF-), body composition and bone health (dual-energy X-ray absorptiometry), measured at 0, 3, 6, and 12 months. Analyses: changes observed in the outcome variables at three months will be compared between patients assigned to BO and to the reference group (delayed treatment) using analysis of the covariance, adjusted for baseline levels. To analyze the association between over time change in physical activity and the outcome variables mixed effects longitudinal models will be used for repeated measures throughout the 12 months of follow-up. Cox proportional hazards models will be used for the survival analysis. Qualitative analyses will combine a deductive approach with an inductive one based on Grounded Theory. In the deductive approach, the researchers will identify several thematic categories related to the Consolidated Framework for Implementation Research. Conclusions: BO is the first experience in Spain of a population-based exercise program that will guarantee, through a scientific evaluation, both clinical and implementation results. This will drastically advance the treatment of people suffering from cancer helping them to reverse the effects of their disease, the adverse effects of the therapies and to improve anti-cancer treatment efficacy, their quality of life and survival

Official Title
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BIZI ORAIN: Exercise for All People With Cancer

Conditions
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Cancer, Quality of Life, Functional Capacity, Exercise

Intervention / Treatment
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* Other: Supervised exercise
* Other: Personalized Program PVS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People diagnosed with cancer within the previous 2 years, under treatment or finished Exclusion Criteria: Neutropenia severe anemia bone metastases any musculoskeletal, cardiovascular or neurological disorder that could place the participant at risk of injury or illness resulting from the exercise program
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised arm<br>Supervised exercise. The intervention will be a free 12-week, small-group ( 10 people) exercise program supervised by specially trained instructors, combining two weekly 1h sessions of moderate to high intensity aerobic and strength exercise. Participants are encouraged to undertake an additional group-based walking exercise guided by target heart rates. | Other: Supervised exercise<br>* a free 12-week, small-group ( 10 people) exercise program supervised by specially trained instructors, combining two weekly 1h sessions of moderate to high intensity aerobic and strength exercise. Participants are encouraged to undertake an additional group-based walking exercise guided by target heart rates.<br>|
| Active Comparator: Control arm<br>Supervised exercise.The intervention will be a Personalized program (PVS), of proven effectiveness for the promotion of physical activity, diet and smoking cessation. After 3 months, it become supervised arm | Other: Supervised exercise<br>* a free 12-week, small-group ( 10 people) exercise program supervised by specially trained instructors, combining two weekly 1h sessions of moderate to high intensity aerobic and strength exercise. Participants are encouraged to undertake an additional group-based walking exercise guided by target heart rates.<br>Other: Personalized Program PVS<br>* a standardized promotion prescription of physical activity, balanced diet and smoking cessation, using the computer tool Promote Healthy Living integrated into the electronic medical record.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Capacity (400 meters walk test) | The 400 meters walk Test applies to assess functional capacity, as well as a predictor of morbidity and mortality in people with different pathologies. Most of the daily activities that the patients with these pathologies are performed at submaximal exercise intensity, similar to this test is performed. It would be measured at 0, 3,6 and 12 months. | One year follow up. Measures at 0,3,6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life (general SF-36) | The HRQL questionnaire is measured blindly with self-administered questionnaires: the Spanish version of the SF-36 and. Questionnaire will be filled out before and after the intervention. SF-36 generates an 8-dimension health profile and two summary scores for the physical and mental components. This questionnaire has been validated in the Spanish population. Measured at 0, 3, 6 and 12 months. | 1 year follow up. Measures at 0,3,6 and 12 months | 
| Change in Quality of life (cancer specific quality of life -European Organization for Research and Treatment of Cancer QLQ-C-30) | Cancer specific quality of life is evaluated by the European Organisation for Research and Treatment of Cancer (QLQ-C-30) questionnaire (Aaronson et al., 1993). The QLQ-C-30 questionnaire includes five functional domains (physical, role, cognitive, emotional and social; higher scores represent greater function/quality of life) and three symptom scales (fatigue, pain and nausea; lower scores represent greater quality of life/less symptom severity).Measured at 0, 3, 6 and 12 months | 1 year follow up. Measures at 0,3,6 and 12 months | 
| symptoms (Cancer-related fatigue - Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | a 13 items scale that measures the cancer related fatigue. The FACT-G scoring guide identifies those items that must be reversed before being added to obtain subscale totals. Negatively stated items are reversed by subtracting the response from 4. After reversing proper items, all subscale items are summed to a total, which is the subscale score.The higher score the score, the better the QOL. Measured at 0, 3, 6 and 12 months | 1 year follow up. Measures at 0,3,6 and 12 months | 
| physical activity level | objectively registered with Actigraph wGT3X-BT accelerometer. Measured at 0, 3, 6 and 12 months | 1 year follow up. Measures at 0,3,6 and 12 months | 
| concentration of Lipids | Lipids:cholesterol (mg/dl), tryglicerides (mg/dl), HDL (mg/dl), LDL(mg/dl). Measured at baseline, and 3 months | 3 months. Measures at 0,3 months. | 
| concentration of C reactive protein | C reactive protein (mg/l). Measured at 0, and 3 months | 3 months. Measures at 0,3 months. | 
| concentration of glucose | glycemia (mg/dl). Measured at 0, and 3 months | 3 months. Measures at 0,3 months. | 
| concentration of Insulin | Insulin (microU/ml). Measured at 0, and 3 months | 3 months. Measures at 0,3 months. | 
| concentration of adiponectin | Exercise specific parameters: adiponectin (microgr/mL). Measured at baseline, and 3 months | 3 months. Measures at 0,3 months. | 
| concentration of TNF | Exercise specific parameters: TNF in Cancer patients (pg/ml) .Measured at baseline, and 3 months | 3 months. Measures at 0,3 months. | 
| concentration of Interleukins II-1 and II-6 | Exercise specific parameters: Interleukins II-1 and II-6 (pg/ml). Measured at baseline, and 3 months | 3 months. Measures at 0,3 months. | 
| Change in Body composition (fat and muscular weight). (BMI) | Body Mass Index (BMI): Diagnoses and classifies obesity. weight and height will be combined to report BMI in kg/m^2). Measured at baseline, and 3, 6, 12 months | 1 year follow up. Measures at 0,3,6 and 12 months |