Lung CancerNCT01546233
Multidisciplinary Education in Lung Cancer Patients Who Receiving Chemotherapy Treatment
An observational study of Lung Cancer, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
The purpose of this study is to compare the fatigue in lung cancer patients receiving chemotherapy treatment, between the education programme in self-care a multidisciplinary with the group who received standard care. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- multidisciplinary education programme and standard education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2012to Dec 2012
- Phase
- Observational
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fatigue Lung Cancer Patients
Who may be able to join
- Aged 45-65 years.
- Has been diagnosed lung cancer stages 3-4 must be chemotherapy is platinum-based, and had received chemotherapy for at least one time, must be in the range of 2-4 cycles of chemotherapy.
- Performance status: ECOG 0-1
- No problem hearing it.
- Read and write Thai.
- Be willing to cooperate in research. And signed a joint research
Who cannot join
- The complications include: high fever, severe nausea and vomiting.
- Injection drug use in diabetes treatment.
- Ischemic heart disease with heart arrhythmia and the drug continuously.
- Is unable to daily living. Caused by defects in movement, and severe osteoarthritis, muscle atrophy, paralysis or walking flat less than 10 meters.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Chemotherapy Unit, Rajavithi Hospital
Bangkok, Bangkok, 10400
About this study
Official title: Outcome of Multidisciplinary Education Programme in Self-care in Fatigue Lung Cancer Patients Who Receiving Chemotherapy Treatment
The purpose of this study is to compare the fatigue in lung cancer patients receiving chemotherapy treatment, between the education programme in self-care a multidisciplinary with the group who received standard care.
Read the detailed description
Educate of self-care by Oncology nurses to relieve and prevent the fatigue of cancer chemotherapy, and provide the manual to read at home, take about 15 minutes. By using home exercise program, 30 minutes of physical education. Teaching and demonstration exercises of the muscles to breath and conservation of energy during exercise and record the exercise/walking diary, the nutritional education nutrition counseling, psychiatric assessment,self-care prevention of depression.
- Conditions
- Lung Cancer
- Being tested
- multidisciplinary education programme, standard education
- Keywords
- Lung cancer, Chemotherapy, Multidisciplinary self care programme, Fatigue
- Medical subject headings
- Lung Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary education programmeBehavioural
Also called multidisciplinary self care education programm
Educate of self-care by Oncology nurses to relieve and prevent the fatigue of cancer chemotherapy, and provide the manual to read at home, take about 15 minutes. By using home exercise program, 30 minutes of physical education. Teaching and demonstration exercises of the muscles to breath and conservation of energy during exercise and record the exercise/walking diary, the nutritional education nutrition counseling, psychiatric assessment,self-care prevention of depression.
standard educationBehavioural
Also called standard education before and after chemotherapy
standard education before and after chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| multidisiplinary self care program | Patient with Lung cancer will be participated in group education with multidisiplinary self care program Receives: Behavioral: multidisciplinary education programme | |
| Conventional education | Lung cancer patient will be received standard education Receives: Behavioral: standard education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure fatigue by questionnaires
Measured: August 2011 to august 2012 (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kotchukorn Wnagnum, Msc (nurse), Principal investigator, Department of Medical Services Ministry of Public Health of Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546233
- Sponsor's protocol ID
- RajavithiMultidisciplinary01
- Status last verified
- Mar 2012
- First submitted
- 1 Mar 2012
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: ๋Journal of the medical association of Thailand
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Multidisciplinary Education Programme in Self-care in Fatigue Lung Cancer Patients Who Receiving Chemotherapy Treatment
- ClinicalTrials.gov ID
- NCT01546233
- Acronym / sponsor ID
- RajavithiMultidisciplinary01
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Chemotherapy, Multidisciplinary self care programme, Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- Mar 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Mar 2012 (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.
The purpose of this study is to compare the fatigue in lung cancer patients receiving chemotherapy treatment, between the education programme in self-care a multidisciplinary with the group who received standard care.
Detailed description
Educate of self-care by Oncology nurses to relieve and prevent the fatigue of cancer chemotherapy, and provide the manual to read at home, take about 15 minutes. By using home exercise program, 30 minutes of physical education. Teaching and demonstration exercises of the muscles to breath and conservation of energy during exercise and record the exercise/walking diary, the nutritional education nutrition counseling, psychiatric assessment,self-care prevention of depression.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multidisiplinary self care program | – | Behavioral: multidisciplinary education programmePatient with Lung cancer will be participated in group education with multidisiplinary self care program |
| Conventional education | – | Behavioral: standard educationLung cancer patient will be received standard education |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fatigue Lung Cancer Patients
Key inclusion criteria (6 listed)
- Aged 45-65 years.
- Has been diagnosed lung cancer stages 3-4 must be chemotherapy is platinum-based, and had received chemotherapy for at least one time, must be in the range of 2-4 cycles of chemotherapy.
- Performance status: ECOG 0-1
- No problem hearing it.
- Read and write Thai.
Key exclusion criteria (4 listed)
- The complications include: high fever, severe nausea and vomiting.
- Injection drug use in diabetes treatment.
- Ischemic heart disease with heart arrhythmia and the drug continuously.
- Is unable to daily living. Caused by defects in movement, and severe osteoarthritis, muscle atrophy, paralysis or walking flat less than 10 meters.
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 |
|---|---|---|
| multidisciplinary education programmeAlso: multidisciplinary self care education programmEducate of self-care by Oncology nurses to relieve and prevent the fatigue of cancer chemotherapy, and provide the manual to read at home, take about 15 minutes. By using home exercise program, 30 minutes of physical education. Teaching and demonstration exercises of the muscles to breath and conservation of energy during exercise and record the exercise/walking diary, the nutritional education nutrition counseling, psychiatric assessment,self-care prevention of depression. | Behavioural | multidisiplinary self care program |
| standard educationAlso: standard education before and after chemotherapystandard education before and after chemotherapy | Behavioural | Conventional education |
Primary outcome
Measure fatigue by questionnaires
Time frame: August 2011 to august 2012 (up to 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Individual participant dataSharing planned: Yes. ๋Journal of the medical association of Thailand
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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.
Kotchukorn Wnagnum, Msc (nurse) principal investigator
Department of Medical Services Ministry of Public Health of Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 6 Jul 2016. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure fatigue by questionnaires (time frame: August 2011 to august 2012 (up to 1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2016.