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

July 22, 2014 updated by: Gonzalo Grandes, Basque Health Service

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise group
supervised exercise program education program on healthy habits Pharmacological treatment and selfcare encouragement
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
No Intervention: control group
Pharmacological treatment and selfcare encouragement.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
asthenia measurement with FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionaire
Time Frame: Basal, 2,6 and12 months
Basal, 2,6 and12 months
Functional Capacity-6 minute Walking test
Time Frame: basal, 2,6 and 12 months
basal, 2,6 and 12 months
cardiorespiratory test
Time Frame: basal, 2, 6 and12 months
basal, 2, 6 and12 months
Changes in Muscular Strenght-Dynamometer
Time Frame: basal, 2,6 nad 12 months
basal, 2,6 nad 12 months
progression-free survival
Time Frame: basal, 2, 6 and 12 months
basal, 2, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basque Health Service

Investigators

  • Principal Investigator: GRANDES GONZALO, Medicine, Primary Care Research Unit of Bizkaia (Basque Health Service)
  • Study Director: ARIETALEANIZBEASCOA MARIA SOLEDAD, NURSE, Primary Care Research Unit of Bizkaia (Basque Health Service)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

July 23, 2014

Last Update Submitted That Met QC Criteria

July 22, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFICANCER PI12/02113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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