Clinical Trial: Effectiveness and Efficiency of Physical Exercise in Cancer Patients
Conditions
Non-Small-Cell Lung Carcinoma - Digestive System Neoplasms - Breast Neoplasms
Conditions: official terms
Breast Neoplasms - Carcinoma, Non-Small-Cell Lung - Digestive System Neoplasms - Gastrointestinal Neoplasms - Lung Neoplasms - Neoplasms
Conditions: Keywords
physical exercise, Health Related Quality of Life, Non-Small-Cell Lung Carcinoma, digestive system neoplasms, breast neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: Supervised Physical activity Type: Other
Name: education program on healthy habits Type: Behavioral
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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)
Location
Primary Care Research Unit of Bizkaia
Bilbao, Bizkaia, Spain
Status: Recruiting
Contact: ARIETALEANIZBEASCOA MARISOL, NURSE - 946006637 - MARIASOLEDAD.ARIETALEANIZBEASCOASARABIA@osakidetza.net
Start Date
April 2013
Completion Date
December 2015
Sponsors
Basque Health Service
Source
Basque Health Service
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page