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

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.

Conditions

• Non-Small-Cell Lung Carcinoma
• Digestive System Neoplasms
• Breast Neoplasms

Interventions

OTHER

Supervised Physical activity

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

BEHAVIORAL

education 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 & Collaborators

• Basque Health Service

  lead OTHER_GOV

Principal Investigators

• GRANDES GONZALO, Medicine · Primary Care Research Unit of Bizkaia (Basque Health Service)

• ARIETALEANIZBEASCOA MARIA SOLEDAD, NURSE · Primary Care Research Unit of Bizkaia (Basque Health Service)

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2015-01-31

Completion

2015-12-31

Countries

• Spain

Study Locations