Quality of LifeNCT03132948
Quality of Life in Pediatric Patients With Acute Lymphoblastic Leukemia Receiving Maintenance Chemotherapy
A study testing Physical Activity in people with Quality of Life, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the impact of exercise on physical activity levels and quality of life in children with acute lymphoblastic leukemia (ALL) receiving maintenance chemotherapy. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2009to 31 Dec 2031
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric oncology patients with ALL in the maintenance phase of chemotherapy during the time of study
- Ages 8-18 years of either gender (age limits due to reliability and validity of outcome assessment surveys)
- Have no documented or observable psychiatric or neurological disorders that would interfere with study participation
- Capable of speaking and reading English
- Having no contraindications to participate in moderate physical exercise as determined by the research staff and the patient's pediatric oncologist
- Currently living with their parents/legal guardians
- Consent obtained from legal guardians and assent obtained from patients to participate in the study
Who cannot join
- Not a pediatric oncology patient with ALL in maintenance
- Not receiving chemotherapy during the time of study
- Age less than 8 years or greater than 18 years
- Not English-speaking Since not all outcome measures have been validated in Spanish and other languages, only English-speaking patients will be included.
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
Official title: Physical Activity and Quality of Life in Pediatric Patients With Acute Lymphoblastic Leukemia Receiving Maintenance Chemotherapy
The purpose of the study is to evaluate the impact of exercise on physical activity levels and quality of life in children with acute lymphoblastic leukemia (ALL) receiving maintenance chemotherapy.
Read the detailed description
Health-related quality of life is an important outcome of cancer treatment which encompasses physical, psychological, social, and functional well-being. In addition, quality of life includes one's overall ability to become a productive member of society and achieve personal fulfillment. Treatment of pediatric cancer is a highly stressful experience which can be challenging and disruptive to the lives of children and their families. Pediatric oncology patients receiving chemotherapy often experience a decline in quality of life due to decreased activity, fatigue, and psychological distress such as depression or anxiety when compared to healthy individuals. Preliminary data suggests that there is an association between physical activity and quality of life. Exercise has been show to improve mood, increase energy levels, and reduce stress. Although more research and clinical resources have been given to the effects of exercise on quality of life among adult cancer patients, there is a lack of research in these areas among children with cancer. The investigators know little about whether children with cancer would benefit from exercise.
The investigators have added a blood sample for biomarkers. Research in adult cancer patients have shown an association between different biomarkers and sleep quality which suggests that regulation of certain biomarkers may be affected through exercise in adults. Measures of biomarkers may provide insight into potential mediators between PA, sleep quality, or fatigue levels.
- Conditions
- Quality of Life
- Being tested
- Physical Activity
- Keywords
- ALL Cancer Patients, Quality of Life, Fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Nintendo WII fit console, Xbox console, sport activities (soccer, basketball, yoga, walking and other physical games)
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | Single arm study where patients choose from physical activities after baseline assessment by PT. Activities include the following: Nintendo WII fit console, Xbox Kinect fit console and other sport activities. Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Outcomes
PedsQL
Measured: 1 year
Secondary outcomes (3)
Physical Activity
Actigraphy
Measured: 1 year
Sleep
Diary
Measured: 1 year
Fatigue
Childhood Fatigue Scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start9 Nov 2009
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Why it stopped: resources unavailable at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Orsey, Connecticut Children's Medical Center
- Investigators
- Andrea Orsey, MD, Principal investigator, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132948
- Sponsor's protocol ID
- 10-086
- Status last verified
- Apr 2026
- First submitted
- 31 Jan 2017
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be de-identified to protect PHI
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Quality of Life in Pediatric Patients With Acute Lymphoblastic Leukemia Receiving Maintenance Chemotherapy
- ClinicalTrials.gov ID
- NCT03132948
- Acronym / sponsor ID
- 10-086
- Conditions
- Quality of Life
- Keywords
- ALL Cancer Patients, Quality of Life, Fitness
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: resources unavailable at this time
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- 9 Nov 2009 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 28 Apr 2017 (actual)
- 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 the study is to evaluate the impact of exercise on physical activity levels and quality of life in children with acute lymphoblastic leukemia (ALL) receiving maintenance chemotherapy.
Detailed description
Health-related quality of life is an important outcome of cancer treatment which encompasses physical, psychological, social, and functional well-being. In addition, quality of life includes one's overall ability to become a productive member of society and achieve personal fulfillment. Treatment of pediatric cancer is a highly stressful experience which can be challenging and disruptive to the lives of children and their families. Pediatric oncology patients receiving chemotherapy often experience a decline in quality of life due to decreased activity, fatigue, and psychological distress such as depression or anxiety when compared to healthy individuals. Preliminary data suggests that there is an association between physical activity and quality of life. Exercise has been show to improve mood, increase energy levels, and reduce stress. Although more research and clinical resources have been given to the effects of exercise on quality of life among adult cancer patients, there is a lack of research in these areas among children with cancer. The investigators know little about whether children with cancer would benefit from exercise.
The investigators have added a blood sample for biomarkers. Research in adult cancer patients have shown an association between different biomarkers and sleep quality which suggests that regulation of certain biomarkers may be affected through exercise in adults. Measures of biomarkers may provide insight into potential mediators between PA, sleep quality, or fatigue levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Behavioral: Physical ActivitySingle arm study where patients choose from physical activities after baseline assessment by PT. Activities include the following: Nintendo WII fit console, Xbox Kinect fit console and other sport activities. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Pediatric oncology patients with ALL in the maintenance phase of chemotherapy during the time of study
- Ages 8-18 years of either gender (age limits due to reliability and validity of outcome assessment surveys)
- Have no documented or observable psychiatric or neurological disorders that would interfere with study participation
- Capable of speaking and reading English
- Having no contraindications to participate in moderate physical exercise as determined by the research staff and the patient's pediatric oncologist
Key exclusion criteria (4 listed)
- Not a pediatric oncology patient with ALL in maintenance
- Not receiving chemotherapy during the time of study
- Age less than 8 years or greater than 18 years
- Not English-speaking Since not all outcome measures have been validated in Spanish and other languages, only English-speaking patients will be included.
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 |
|---|---|---|
| Physical ActivityNintendo WII fit console, Xbox console, sport activities (soccer, basketball, yoga, walking and other physical games) | Behavioural | Physical Activity |
Primary outcome
Quality of Life Outcomes
Time frame: 1 year
PedsQL
3 secondary outcomes
Physical Activity
Time frame: 1 year
Sleep
Time frame: 1 year
Fatigue
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. data will be de-identified to protect PHI
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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.
Andrea Orsey, MD principal investigator
Connecticut Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Quality of Life, run by Connecticut Children's Medical Center at 1 site in United States.
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 7 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: paused, as of the sponsor's last update on 13 Apr 2026. 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 United States. 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.
What does the primary outcome measure?
Quality of Life Outcomes (time frame: 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 13 Apr 2026.