Non-Small-Cell Lung CarcinomaEFICANCERNCT01786122
Clinical Trial: Effectiveness and Efficiency of Physical Exercise in Cancer Patients
A study testing Supervised Physical activity and education program on healthy habits in people with Non-Small-Cell Lung Carcinoma and Digestive System Neoplasms, run by Basque Health Service at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma, Digestive System Neoplasms, Breast Neoplasms
- What is being tested?
- Supervised Physical activity and education program on healthy habits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Maria Soledad Arietaleanisbeaskoa, Nurse contact
Spain1 site, 1 recruiting
- Recruiting
Primary Care Research Unit of Bizkaia
Bilbao, Bizkaia, 48014
ARIETALEANIZBEASCOA MARISOL, NURSE, 946006637, MARIASOLEDAD.ARIETALEANIZBEASCOASARABIA@osakidetza.net
ARCE ARANA, NURSE, 946006637, VERONICA.ARCEARANA@osakidetza.net
About this study
Official title: 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.
- Being tested
- Supervised Physical activity, education program on healthy habits
- Keywords
- physical exercise, Health Related Quality of Life, Non-Small-Cell Lung Carcinoma, digestive system neoplasms, breast neoplasms
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Digestive System Neoplasms, Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
education program on healthy habitsBehavioural
education program on healthy habits for 2 months in the PHC and a second phase in community facilities during the remaining 10 months
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | supervised exercise program education program on healthy habits Pharmacological treatment and selfcare encouragement Receives: Other: Supervised Physical activity; Behavioral: education program on healthy habits |
| control group | No intervention | Pharmacological treatment and selfcare encouragement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Health Related Quality of Life (EORTC QLQ-C30)
Measured: basal,2,6,12 months fllow up
Secondary outcomes (5)
asthenia measurement with FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionaire
Measured: Basal, 2,6 and12 months
Functional Capacity-6 minute Walking test
Measured: basal, 2,6 and 12 months
cardiorespiratory test
Measured: basal, 2, 6 and12 months
Changes in Muscular Strenght-Dynamometer
Measured: basal, 2,6 nad 12 months
progression-free survival
Measured: basal, 2, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Small-Cell Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gonzalo Grandes, Basque Health Service
- Investigators
- GRANDES GONZALO, Medicine, Principal investigator, Primary Care Research Unit of Bizkaia (Basque Health Service)ARIETALEANIZBEASCOA MARIA SOLEDAD, NURSE, Study director, Primary Care Research Unit of Bizkaia (Basque Health Service)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786122
- Sponsor's protocol ID
- EFICANCER PI12/02113
- Acronym
- EFICANCER
- Status last verified
- Jul 2014
- First submitted
- 5 Feb 2013
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37183104Sancho 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.
PubMed 25655792
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHYSICAL EXERCISE TO IMPROVE THE QUALITY OF LIFE OF CANCER PATIENTS DURING TREATMENT PROCESS: EFICANCER STUDY
- ClinicalTrials.gov ID
- NCT01786122
- Acronym / sponsor ID
- EFICANCER / EFICANCER PI12/02113
- Keywords
- physical exercise, Health Related Quality of Life, Non-Small-Cell Lung Carcinoma, digestive system neoplasms, breast neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Apr 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Supervised Physical activity, Behavioral: education program on healthy habitssupervised exercise program education program on healthy habits Pharmacological treatment and selfcare encouragement |
| control group | No intervention | –Pharmacological treatment and selfcare encouragement. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Physical activityBoth 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 | Other | Exercise group |
| education program on healthy habitseducation program on healthy habits for 2 months in the PHC and a second phase in community facilities during the remaining 10 months | Behavioural | Exercise group |
Primary outcome
Changes in Health Related Quality of Life (EORTC QLQ-C30)
Time frame: basal,2,6,12 months fllow up
5 secondary outcomes
asthenia measurement with FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionaire
Time frame: Basal, 2,6 and12 months
Functional Capacity-6 minute Walking test
Time frame: basal, 2,6 and 12 months
cardiorespiratory test
Time frame: basal, 2, 6 and12 months
Changes in Muscular Strenght-Dynamometer
Time frame: basal, 2,6 nad 12 months
progression-free survival
Time frame: basal, 2, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
- Derived from this study: PubMed 37183104Mendizabal-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.
- Derived from this study: PubMed 25655792Sancho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Soledad Arietaleanisbeaskoa, Nurse contact
GRANDES GONZALO, Medicine principal investigator
Primary Care Research Unit of Bizkaia (Basque Health Service)
ARIETALEANIZBEASCOA MARIA SOLEDAD, NURSE study director
Primary Care Research Unit of Bizkaia (Basque Health Service)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Physical activity and education program on healthy habits in people with Non-Small-Cell Lung Carcinoma and Digestive System Neoplasms, run by Basque Health Service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gonzalo Grandes, Medicine (0034946006637, GONZALO.GRANDESODRIOZOLA@osakidetza.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Health Related Quality of Life (EORTC QLQ-C30) (time frame: basal,2,6,12 months fllow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01786122, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.