Breast Neoplasms, Digestive System Neoplasms, Non-Small-Cell Lung Carcinoma
Conditions
Keywords
physical exercise, Health Related Quality of Life, Non-Small-Cell Lung Carcinoma, digestive system neoplasms, breast neoplasms
Brief summary
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.
Interventions
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
BEHAVIORALeducation 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
Sponsors
Basque Health Service
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Health Related Quality of Life (EORTC QLQ-C30) | basal,2,6,12 months fllow up |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
Spain
Contacts
Primary ContactGonzalo Grandes, Medicine
Backup ContactMaria Soledad Arietaleanisbeaskoa, Nurse
Outcome results
None listed