NCT01786122

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 23, 2014

Status Verified

July 1, 2014

Enrollment Period

1.8 years

First QC Date

February 5, 2013

Last Update Submit

July 22, 2014

Conditions

Non-Small-Cell Lung CarcinomaDigestive System NeoplasmsBreast Neoplasms

Keywords

physical exerciseHealth Related Quality of LifeNon-Small-Cell Lung Carcinomadigestive system neoplasmsbreast neoplasms

Outcome Measures

Primary Outcomes (1)

  • Changes in Health Related Quality of Life (EORTC QLQ-C30)

    basal,2,6,12 months fllow up

Secondary Outcomes (5)

  • 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

  • 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

Study Arms (2)

Exercise group

EXPERIMENTAL

supervised exercise program education program on healthy habits Pharmacological treatment and selfcare encouragement

Other: Supervised Physical activityBehavioral: education program on healthy habits

control group

NO INTERVENTION

Pharmacological treatment and selfcare encouragement.

Interventions

Supervised Physical activityOTHER

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

Exercise group
education program on healthy habitsBEHAVIORAL

education program on healthy habits for 2 months in the PHC and a second phase in community facilities during the remaining 10 months

Exercise group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Care Research Unit of Bizkaia

Bilbao, Bizkaia, 48014, Spain

RECRUITING

Related Publications (2)

  • Mendizabal-Gallastegui N, Arietaleanizbeaskoa MS, Latorre PM, Garcia-Alvarez A, Sancho A, Iruarrizaga E, Lopez-Vivanco G, Grandes G. Nurse-Supervised Exercise for People with Stage IV Cancer: The EFICANCER Randomized Clinical Trial. Semin Oncol Nurs. 2023 Aug;39(4):151448. doi: 10.1016/j.soncn.2023.151448. Epub 2023 May 13.

    PMID: 37183104DERIVED

  • Sancho A, Carrera S, Arietaleanizbeascoa M, Arce V, Gallastegui NM, Gine March A, Sanz-Guinea A, Eskisabel A, Rodriguez AL, Martin RA, Lopez-Vivanco G, Grandes G. Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial. BMC Cancer. 2015 Feb 6;15:40. doi: 10.1186/s12885-015-1055-x.

    PMID: 25655792DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungDigestive System NeoplasmsBreast NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDigestive System DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Officials

  • GRANDES GONZALO, Medicine

    Primary Care Research Unit of Bizkaia (Basque Health Service)

    PRINCIPAL INVESTIGATOR

  • ARIETALEANIZBEASCOA MARIA SOLEDAD, NURSE

    Primary Care Research Unit of Bizkaia (Basque Health Service)

    STUDY DIRECTOR

Central Study Contacts

Gonzalo Grandes, Medicine

CONTACT

0034946006637GONZALO.GRANDESODRIOZOLA@osakidetza.net

Maria Soledad Arietaleanisbeaskoa, Nurse

CONTACT

0034946006637MARIASOLEDAD.ARIETALEANIZBEASCOASARABIA@osakidetza.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Family Medicine specialist, master in epidemiology; Head of the Research Unit of Family Medicine of Bizkaia

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 7, 2013

Study Start

April 1, 2013

Primary Completion

January 1, 2015

Study Completion

December 1, 2015

Last Updated

July 23, 2014

Record last verified: 2014-07

Locations

ES(1)