Acute LeukemiaNCT01603290
Change of Fatigue and Physical Fitness in Hospitalized Hematology Patients
An observational study of Acute Leukemia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purposes of this study are to (1) explore the severity of symptom of leukemia patients experienced before and after chemotherapy in hospital, (2) investigate the trajectories of the fatigue and physical fitness, and their related factors, and (3) the correlation between fatigue and physical fitness Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Leukemia
- How many people
- 130 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2011to Dec 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute leukemia inpatients
Who may be able to join
- Acute leukemia patients with first complete remission status
- Aged above 20
- Be going to receive chemotherapy and in hospital at least one week.
- Those Who willing to participate in the research
Who cannot join
- Physician consider the patient was not suitable
- Patients' limbs can not move
- Patients' conscious was unclear during hospitalization
- Patient with pain of joint and can't do 30-second chair stand test and 6-Minute Walking Test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Change of Fatigue and Physical Fitness and Their Related Factors in Hospitalized Hematology Patients
The purposes of this study are to (1) explore the severity of symptom of leukemia patients experienced before and after chemotherapy in hospital, (2) investigate the trajectories of the fatigue and physical fitness, and their related factors, and (3) the correlation between fatigue and physical fitness
Read the detailed description
Cancer-Related Fatigue (CRF) is one of the common distressed symptoms that leukemia patients experienced during the period of chemotherapy. Exercise is the most effective non-pharmacologic treatment but inpatients refuse to do exercise in clinical settings in Taiwan. Decreased physical activity may increase the intensity of fatigue and degenerate the physical fitness; however, there is no study to explore the trajectories of fatigue and physical fitness for leukemia patient during hospitalization. Therefore, the purposes of this study are to (1) explore the severity of symptom of leukemia patients experienced before and after chemotherapy in hospital, (2) investigate the trajectories of the fatigue and physical fitness, and their related factors, and (3) the correlation between fatigue and physical fitness. A longitudinal designed study will be conducted to recruit the leukemia patients in a medical center in Taipei. Eligible patients are those will be going to receive chemotherapy and in hospital at least one week. Time periods for data collection will be in the first 48 hours after hospitalization (T0) and the 48 hours before the patient discharged (T1). A set of structured questionnaire will be used to collected data including the Background information form, the Fatigue Symptom Inventory, the Cancer Fatigue Scale, the Symptom Severity Scale, and the Hospital Anxiety and Depression Scale. Patients will be received physical fitness test including the 6-Minute Walking Test, grip strength, and 30-second chair stand test. The descriptive statistics will be used to analyze the severity of symptom distress, fatigue, and the change of physical fitness, and the inferential statistics was used to analyze the correlation of the symptom, fatigue, and physical fitness. Besides, generalized estimating equations (GEE) will be used to analysis the average of population change of fatigue and physical fitness.
- Conditions
- Acute Leukemia
- Keywords
- Acute leukemia,, Chemotherapy,, Cancer-Related Fatigue,, Physical Fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized Leukemia Patients | leukemia patients with chemotherapy during hospitalization |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603290
- Sponsor's protocol ID
- 201111066RIC
- Status last verified
- May 2012
- First submitted
- 18 May 2012
- Last updated
- 22 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Fatigue and Physical Fitness and Their Related Factors in Hospitalized Hematology Patients
- ClinicalTrials.gov ID
- NCT01603290
- Acronym / sponsor ID
- 201111066RIC
- Conditions
- Acute Leukemia
- Keywords
- Acute leukemia,, Chemotherapy,, Cancer-Related Fatigue,, Physical Fitness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 May 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 purposes of this study are to (1) explore the severity of symptom of leukemia patients experienced before and after chemotherapy in hospital, (2) investigate the trajectories of the fatigue and physical fitness, and their related factors, and (3) the correlation between fatigue and physical fitness
Detailed description
Cancer-Related Fatigue (CRF) is one of the common distressed symptoms that leukemia patients experienced during the period of chemotherapy. Exercise is the most effective non-pharmacologic treatment but inpatients refuse to do exercise in clinical settings in Taiwan. Decreased physical activity may increase the intensity of fatigue and degenerate the physical fitness; however, there is no study to explore the trajectories of fatigue and physical fitness for leukemia patient during hospitalization. Therefore, the purposes of this study are to (1) explore the severity of symptom of leukemia patients experienced before and after chemotherapy in hospital, (2) investigate the trajectories of the fatigue and physical fitness, and their related factors, and (3) the correlation between fatigue and physical fitness. A longitudinal designed study will be conducted to recruit the leukemia patients in a medical center in Taipei. Eligible patients are those will be going to receive chemotherapy and in hospital at least one week. Time periods for data collection will be in the first 48 hours after hospitalization (T0) and the 48 hours before the patient discharged (T1). A set of structured questionnaire will be used to collected data including the Background information form, the Fatigue Symptom Inventory, the Cancer Fatigue Scale, the Symptom Severity Scale, and the Hospital Anxiety and Depression Scale. Patients will be received physical fitness test including the 6-Minute Walking Test, grip strength, and 30-second chair stand test. The descriptive statistics will be used to analyze the severity of symptom distress, fatigue, and the change of physical fitness, and the inferential statistics was used to analyze the correlation of the symptom, fatigue, and physical fitness. Besides, generalized estimating equations (GEE) will be used to analysis the average of population change of fatigue and physical fitness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Leukemia Patients | – | –leukemia patients with chemotherapy during hospitalization |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute leukemia inpatients
Key inclusion criteria (4 listed)
- Acute leukemia patients with first complete remission status
- Aged above 20
- Be going to receive chemotherapy and in hospital at least one week.
- Those Who willing to participate in the research
Key exclusion criteria (4 listed)
- Physician consider the patient was not suitable
- Patients' limbs can not move
- Patients' conscious was unclear during hospitalization
- Patient with pain of joint and can't do 30-second chair stand test and 6-Minute Walking Test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Leukemia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 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: status not confirmed, as of the sponsor's last update on 22 May 2012. 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 Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 22 May 2012.