Acute LeukemiaEarly Phase 1PACE-ALNCT01557686
Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study
A Early Phase 1 study testing Health counseling and exercise in people with Acute Leukemia, run by Universitetshospitalernes Center for Sygepleje at 2 sites in Denmark.
Trial summary
The purpose of this pilot study is to test an exercise-based multidimensional intervention for patients with acute leukaemia undergoing consolidation chemotherapy in the context of outpatient management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- Health counseling and exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2010to Feb 2011
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that are able to speak Danish > 18 years and newly diagnosed with acute leukæmia (MDS, AML, CMML, APL or ALL)
- Normal EKG, blood pressure and pulse
- Signed informed written consent
Who cannot join
- Medical reason that contraindicates physical activity
- Patients diagnosed with a symptomatic cardiac disease within the last three months.
- Documented bone metastasis
- Dementia, psychotic
- Cannot write or read Danish
- Patients unable to carry out baseline tests
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Copenhagen University Hospital
Copenhagen
Herlev Hospital
Herlev
About this study
Official title: Patient Activation Through Counseling and Exercise - Acute Leukemia - Pilot Trial
The purpose of this pilot study is to test an exercise-based multidimensional intervention for patients with acute leukaemia undergoing consolidation chemotherapy in the context of outpatient management. Further, to test for safety, feasibility and preliminary effect on physical and functional capacity, and health related quality of life.
- Conditions
- Acute Leukemia
- Being tested
- Health counseling and exercise
- Keywords
- Cancer Related fatigue, Quality of Life, Psychosocial Intervention, Rehabilitation, Physical Fitness, Physical Activity, Exercise Therapy, Exercise, Hematologic, Hematological, Leukemia, Myeloid, Acute, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Leukemia
- Medical subject headings
- Motor Activity, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health counseling and exerciseBehavioural
The intervention is initiated during chemotherapy treatment (consolidation) in the outpatient clinic and continues for 6 weeks. The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and two health-promoting counseling sessions - Further, patients are fitted with a step counter pedometer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - adherence rates
Percentage of intervention participation
Measured: Adherence to the intervention components from baseline to 6 weeks
Secondary outcomes (9)
Adverse events
Number and type of adverse events
Measured: baseline to 6 weeks
6MWD
Change in distance in meter
Measured: Change from baseline in 6MWD at 6 weeks
Attrition
Number of patients that withdrew from the project
Measured: Withdrawal from the project from baseline to 6 weeks
Timed chair stand
Change in the number of repetitions
Measured: Change from baseline in timed chair stand at 6 weeks
Timed bicep curl
Change in number of repetitions
Measured: Change from baseline in timed bicep curl at 6 weeks
FACT-Anemia
Change in scores for quality of life/function
Measured: Change from baseline in FACT-An at 6 weeks
HADS
Change in scores for emotional wellbeing
Measured: Change from baseline in HADS at 6 weeks
SF36
Change in scores for general health
Measured: Change from baseline in SF36 at 6 weeks
MDSAI
Change in scores for symptom burden
Measured: Change from baseline over time (1,2,3,4,5,6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionFeb 2011
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.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitetshospitalernes Center for Sygepleje
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, Lundbeck Foundation
- Responsible party
- Principal investigator, Mary Jarden, Universitetshospitalernes Center for Sygepleje
- Investigators
- Mary Jarden, Ph.D., Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557686
- Sponsor's protocol ID
- H-4-2010-046 Pilot
- Acronym
- PACE-AL
- Status last verified
- Mar 2012
- First submitted
- 15 Mar 2012
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Activation Through Counseling and Exercise - Acute Leukemia - Pilot Trial
- ClinicalTrials.gov ID
- NCT01557686
- Acronym / sponsor ID
- PACE-AL / H-4-2010-046 Pilot
- Conditions
- Acute Leukemia
- Keywords
- Cancer Related fatigue, Quality of Life, Psychosocial Intervention, Rehabilitation, Physical Fitness, Physical Activity, Exercise Therapy, Exercise
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitetshospitalernes Center for SygeplejeUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Lundbeck Foundation
- Study start
- May 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 19 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 pilot study is to test an exercise-based multidimensional intervention for patients with acute leukaemia undergoing consolidation chemotherapy in the context of outpatient management. Further, to test for safety, feasibility and preliminary effect on physical and functional capacity, and health related quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients that are able to speak Danish > 18 years and newly diagnosed with acute leukæmia (MDS, AML, CMML, APL or ALL)
- Normal EKG, blood pressure and pulse
- Signed informed written consent
Key exclusion criteria (6 listed)
- Medical reason that contraindicates physical activity
- Patients diagnosed with a symptomatic cardiac disease within the last three months.
- Documented bone metastasis
- Dementia, psychotic
- Cannot write or read Danish
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 |
|---|---|---|
| Health counseling and exerciseThe intervention is initiated during chemotherapy treatment (consolidation) in the outpatient clinic and continues for 6 weeks. The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and two health-promoting counseling sessions - Further, patients are fitted with a step counter pedometer. | Behavioural | – |
Primary outcome
Feasibility - adherence rates
Time frame: Adherence to the intervention components from baseline to 6 weeks
Percentage of intervention participation
9 secondary outcomes
Adverse events
Time frame: baseline to 6 weeks
6MWD
Time frame: Change from baseline in 6MWD at 6 weeks
Attrition
Time frame: Withdrawal from the project from baseline to 6 weeks
Timed chair stand
Time frame: Change from baseline in timed chair stand at 6 weeks
Timed bicep curl
Time frame: Change from baseline in timed bicep curl at 6 weeks
FACT-Anemia
Time frame: Change from baseline in FACT-An at 6 weeks
HADS
Time frame: Change from baseline in HADS at 6 weeks
SF36
Time frame: Change from baseline in SF36 at 6 weeks
MDSAI
Time frame: Change from baseline over time (1,2,3,4,5,6 weeks)
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 19 Mar 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.
Mary Jarden, Ph.D. principal investigator
Copenhagen University Hospital at Herlev
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Health counseling and exercise in people with Acute Leukemia, run by Universitetshospitalernes Center for Sygepleje at 2 sites in Denmark.
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 3 inclusion and 6 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 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility - adherence rates (time frame: Adherence to the intervention components from baseline to 6 weeks). 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 19 Mar 2012.