Pediatric CancerPePANCT06012825
Pediatric Physical Activity for Children With Cancer
An observational study of Pediatric Cancer and Physical Activity, run by University of Hawaii at 3 sites in United States.
Trial summary
The goal of this pilot study is to test the feasibility and participant adherence (pediatric patients diagnosed with childhood cancer) to a virtual, 12-week physical activity program. The aims of this project are to: 1. Determine the feasibility of administering the program and patient acceptability. 2. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Pediatric Cancer, Physical Activity
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2022to 12 May 2023
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients referred by their physician at a primary care facility.
Who may be able to join
- Having been diagnosed with cancer
- Ability to connect to virtual sessions 2x/week
- English literacy
- Having guardian consent and patient assent.
- Eligible patients will be those who do not require physical therapy (i.e., able to dress, ambulate) and will be physically able to participate, as determined by therapy staff.
Who cannot join
- Not having been diagnosed with cancer.
- Inability to communicate in English
- Requires physical or occupational therapy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
University of Hawaii at Manoa
Honolulu, Hawaii, 96822
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, 96826
About this study
Official title: Pediatric Physical Activity (PePA): Understanding Best Practices in Implementing Physical Activity for Patients Diagnosed With Childhood Cancer
The goal of this pilot study is to test the feasibility and participant adherence (pediatric patients diagnosed with childhood cancer) to a virtual, 12-week physical activity program.
The aims of this project are to:
Read more
- Determine the feasibility of administering the program and patient acceptability.
- Report program adherence and completion rates.
- Explore trends on the impact of a virtual PA intervention on psychosocial health and physical fitness.
Participants will undergo pre- and post-assessments including measurements of fitness, self-reported fatigue and depression symptoms, social support, and current amount of physical activity. Patients will then be invited to participate in two consecutive, 12-week virtual physical activity interventions with similar-aged peers (2x/week, 60 minutes/session) over 2 rounds.
Read the detailed description
It is critical for childhood cancer patients to maintain a physical activity (PA) regime as they are at an increased risk of developing co-morbidities. PA engagement is associated with positive psychosocial outcomes, and it has the potential to improve cardiopulmonary and musculoskeletal function. Patients will be enrolled and will undergo baseline assessments of fitness and quality of life as part of their standard care, and additional measures that include fatigue, depression, social support, and PA volume will be measured. Patients will be invited to participate in a 12-week virtual PA intervention with similar-aged peers (2x/week, 60 minutes/session). Patients will be led through activities that are culturally relevant and age-appropriate. At the end of the 12-week intervention, the same tests will be completed. The patients will have an opportunity to receive 2 interventions. A mixed method design will be used, where quantitative data will include information related to feasibility, PA volume, physical fitness, and psychosocial health measures, and qualitative data will be collected from the patients during the focus groups.
- Conditions
- Pediatric Cancer, Physical Activity
- Being tested
- Physical Activity
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
The program will consist of 2 consecutive rounds of 12-week programming, 2x/week for 60 minutes on a Health Insurance Portability and Accountability Act (HIPAA)-compliant Zoom account. The PA program will be structured to ensure equivalent "PA doses" are provided. This will be done by allocating time to a warm-up (5 min), an introduction and demonstration of the activity (5 min), the PA (30 min), cool down and stretching (5 min). Time will also be devoted for interaction to develop rapport, transition to the next activity, and to handle internet connectivity issues (15 min).
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity (PA) Round 1 | All enrollees will have the opportunity to attend virtual PA sessions. Receives: Behavioral: Physical Activity | |
| Physical Activity Round 2 | This second cohort is the 2nd round of intervention, which allows participants to enroll for another round, and/or newly recruited patients will have the opportunity to participate. Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment
The number of enrolled patients
Measured: Tracked at the time of enrollment
Duration in minutes
The investigators will determine if the delivery of a virtual physical activity program is feasible by tracking the number of minutes spent in the warm up, activity and cool-down.
Measured: Duration (minutes) will be measured each session up to 12 weeks.
Heart Rate
In order to objectively measure the intensity level and volume of PA during the activity sessions, participants will wear accelerometers on their waist and a wrist-based heart rate will be used to intensity of PA in real-time.
Measured: Intensity ( heart rate) will be measured each session up to 12 weeks.
Relative Rate of Perceived Exertion
Rate of perceived exertion (RPE) will be obtained from participants as a subjective measure of intensity.
Measured: Intensity (RPE) will be measured each session up to 12 weeks.
Acceptability of the program by patients
The virtual activities also need to enjoyable, so with the use of focus groups, patient acceptability of the program will be determined. Predetermined questions and prompts will be used, such as, "Describe a lesson or lessons you liked best. What are some lessons that were less enjoyable? What was the most difficult aspect of participating in PePA? In general, did the exercises feel like they provided the right amount of exertion, too intense, not intense enough? Was the duration of each session too long, too short or about right?". The focus group recording will be transcribed and themes will be identified in this qualitative analysis.
Measured: Focus groups will be conducted up to 12 weeks.
Adherence
The number of completing patients. This will be measured by counting the number of participants who completed the majority of the program for each round (i.e., 20 out of 24 sessions).
Measured: Attendance will be measured each week up to 12 weeks. If the participant continues for a second round, adherence will be measured each week during the second intervention up to 12 weeks.
Secondary outcomes (11)
Health-related quality of life (QL)
The investigators will explore the trends of a virtual physical activity program with the following measure:
Quality of life with the Pediatric Quality of Life Inventory General Well-Being Scale (PedsQL Inventory, 23 items). Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores reflect better outcomes.
Measured: Change from baseline QL at 12 weeks.
Physical Activity Intention
The investigators will explore the trends of a virtual physical activity program on the following measure:
Physical Activity (PA) intention with the PA Intention Inventory (6 items). The first 3 items ask about the number of days over the past week the participant engaged in PA for 60 minutes, the number of days PA was engaged which resulted in elevated heart rate, and the number of days that the participant engaged in resistance exercises. Responses range from 0-7 days with greater days indicating more activity.
The last 3 questions ask the participant about his/her intention to engage in PA outside of school, participate in PA which makes him/her breathe hard in the next 2 weeks and if s/he expects to exercise outside of school that makes him/her breathe hard in the next 2 weeks. Answers correspond to 0=strongly agree, 1=agree, 2= not sure, 3=disagree, 4=strongly disagree. Scores range from 0-12, with lower scores reflecting better outcomes.
Measured: Change from baseline physical activity intention at 12 weeks.
Social Support
The investigators will explore the trends of a virtual physical activity program on the following measure:
Social support toward PA from friends and parents (Social Support Questionnaire, 8 items). Items are answered with very often (0), often (1), neutral (2), sometimes (3) or never (4). Scores range from 0 to 32. Lower scores represent better outcomes.
Measured: Change from baseline Social Support at 12 weeks.
Fatigue
The investigators will explore the trends of a virtual physical activity program on the following measure:
Fatigue using the PedsQL Multidimensional Fatigue Scale Questionnaire (18 items). Items are transformed to a 0-100 scale, where 0=100, 1=75, 3=25, 4=0. Scores are averaged (divided by 18) and range from 0-100. Higher scores indicate fewer problems.
Measured: Change from baseline Fatigue at 12 weeks.
Depression
The investigators will explore the trends of a virtual physical activity program on the following measure:
Depression using the Children's Depression Inventory (12 items). Items 1, 3-6, 8, 10-12 correspond to emotional problems. Items 2, 7, 9, 13-17 correspond to function problems. Reverse scoring is used for items 2, 7, 13, 14, 16. Higher scores indicate greater problems. Scores are compared to normative ranges (0-39+), which are age- and sex-dependent.
Measured: Change from baseline Depression at 12 weeks.
Cardiorespiratory endurance
The investigators will explore the trends of a virtual physical activity program on the following measure:
Cardiorespiratory endurance using the 6-minute walk test (ml/kg/min).
Measured: Change from baseline Cardiorespiratory Endurance at 12 weeks.
Flexibility
The investigators will explore the trends of a virtual physical activity program on the following measure:
Range of motion using goniometry (degrees).
Measured: Change from baseline Flexibility at 12 weeks.
Hand Strength
The investigators will explore the trends of a virtual physical activity program on the following measure:
Hand strength will be measured with hand-held dynamometry (kg).
Measured: Change from baseline Hand Strength at 12 weeks.
Muscular Strength
The investigators will explore the trends of a virtual physical activity program on the following measure:
A manual muscle testing (scale that rates trace, poor, fair, good, normal performance) will be used to measure Muscular Strength.
Measured: Change from baseline Muscular Strength at 12 weeks.
Balance
The investigators will explore the trends of a virtual physical activity program on the following measure:
Balance using the Berg Balance Scale (14 items). Scores range from 0 to 56 with higher scores reflecting better outcomes.
Measured: Change from baseline Balance at 12 weeks.
Activity of daily living (ADL)
The investigators will explore the trends of a virtual physical activity program on the following measure:
Assessment of the ability to perform activities of daily living (ADL, QuickDASH Inventory, 11 items). Items are scored as no difficulty (1), mild difficulty (2), moderate difficulty (3), severe difficult (4), to unable to achieve (5). At least 10 items need to be completed and is measured on a scale of 0-100 with a higher score indicating greater disability.
Measured: Change from baseline ADL at 12 weeks..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Jan 2022
- Primary completion9 May 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pediatric 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Hawaii Pacific Health, University of Hawaii Cancer Research Center
- Responsible party
- Principal investigator, Paulette M. Yamada, University of Hawaii
- Investigators
- Paulette Yamada Tamashiro, PhD, Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012825
- Sponsor's protocol ID
- 2021-084
- Acronym
- PePA
- Status last verified
- Nov 2023
- First submitted
- 4 May 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Since the number of subjects that will is small (n=12), IPD may be easily tracked to the patient themselves. If it is possible to mask / de-identify data, IPD may be shared at the conclusion of this study.
Publications
Ouyang N, Cai R, Zhou X, Huang H, Qiu X, Liu K. Effects of a group-based physical activity program for pediatric patients with cancer on physical activity and symptom experience: A quasi-experimental study. Pediatr Blood Cancer. 2019 Nov;66(11):e27965. doi: 10.1002/pbc.27965. Epub 2019 Aug 12.
PubMed 31407493Honas JJ, Washburn RA, Smith BK, Greene JL, Cook-Wiens G, Donnelly JE. The System for Observing Fitness Instruction Time (SOFIT) as a measure of energy expenditure during classroom-based physical activity. Pediatr Exerc Sci. 2008 Nov;20(4):439-45. doi: 10.1123/pes.20.4.439.
PubMed 19168920Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
PubMed 11932914Panepinto JA, Torres S, Bendo CB, McCavit TL, Dinu B, Sherman-Bien S, Bemrich-Stolz C, Varni JW. PedsQL Multidimensional Fatigue Scale in sickle cell disease: feasibility, reliability, and validity. Pediatr Blood Cancer. 2014 Jan;61(1):171-7. doi: 10.1002/pbc.24776. Epub 2013 Sep 13.
PubMed 24038960Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.
PubMed 17057441Quatman-Yates CC, Gupta R, Paterno MV, Schmitt LC, Quatman CE, Ittenbach RF. Internal consistency and validity of the QuickDASH instrument for upper extremity injuries in older children. J Pediatr Orthop. 2013 Dec;33(8):838-42. doi: 10.1097/BPO.0b013e3182a00688.
PubMed 23863415Rider BC, Conger SA, Ditzenberger GL, Besteman SS, Bouret CM, Coughlin AM. Examining the Accuracy of the Polar A360 Monitor. J Strength Cond Res. 2021 Aug 1;35(8):2165-2169. doi: 10.1519/JSC.0000000000003136.
PubMed 34398076Yamada PM, Centeio EC, Bantum EO, Cao S, Lopez GM. Informing the delivery of physical activity leadership for pediatric patients undergoing cancer treatment. International Journal of Kinesiology in Higher Education, Sept 2023. DOI: 10.1080/24711616.2023.2237427
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Physical Activity (PePA): Understanding Best Practices in Implementing Physical Activity for Patients Diagnosed With Childhood Cancer
- ClinicalTrials.gov ID
- NCT06012825
- Acronym / sponsor ID
- PePA / 2021-084
- Conditions
- Pediatric Cancer, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- Hawaii Pacific Health, University of Hawaii Cancer Research Center
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 28 Aug 2023 (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 goal of this pilot study is to test the feasibility and participant adherence (pediatric patients diagnosed with childhood cancer) to a virtual, 12-week physical activity program.
The aims of this project are to:
- Determine the feasibility of administering the program and patient acceptability.
- Report program adherence and completion rates.
- Explore trends on the impact of a virtual PA intervention on psychosocial health and physical fitness.
Participants will undergo pre- and post-assessments including measurements of fitness, self-reported fatigue and depression symptoms, social support, and current amount of physical activity. Patients will then be invited to participate in two consecutive, 12-week virtual physical activity interventions with similar-aged peers (2x/week, 60 minutes/session) over 2 rounds.
Detailed description
It is critical for childhood cancer patients to maintain a physical activity (PA) regime as they are at an increased risk of developing co-morbidities. PA engagement is associated with positive psychosocial outcomes, and it has the potential to improve cardiopulmonary and musculoskeletal function. Patients will be enrolled and will undergo baseline assessments of fitness and quality of life as part of their standard care, and additional measures that include fatigue, depression, social support, and PA volume will be measured. Patients will be invited to participate in a 12-week virtual PA intervention with similar-aged peers (2x/week, 60 minutes/session). Patients will be led through activities that are culturally relevant and age-appropriate. At the end of the 12-week intervention, the same tests will be completed. The patients will have an opportunity to receive 2 interventions. A mixed method design will be used, where quantitative data will include information related to feasibility, PA volume, physical fitness, and psychosocial health measures, and qualitative data will be collected from the patients during the focus groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity (PA) Round 1 | – | Behavioral: Physical ActivityAll enrollees will have the opportunity to attend virtual PA sessions. |
| Physical Activity Round 2 | – | Behavioral: Physical ActivityThis second cohort is the 2nd round of intervention, which allows participants to enroll for another round, and/or newly recruited patients will have the opportunity to participate. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients referred by their physician at a primary care facility.
Key inclusion criteria (5 listed)
- Having been diagnosed with cancer
- Ability to connect to virtual sessions 2x/week
- English literacy
- Having guardian consent and patient assent.
- Eligible patients will be those who do not require physical therapy (i.e., able to dress, ambulate) and will be physically able to participate, as determined by therapy staff.
Key exclusion criteria (3 listed)
- Not having been diagnosed with cancer.
- Inability to communicate in English
- Requires physical or occupational therapy.
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 ActivityThe program will consist of 2 consecutive rounds of 12-week programming, 2x/week for 60 minutes on a Health Insurance Portability and Accountability Act (HIPAA)-compliant Zoom account. The PA program will be structured to ensure equivalent "PA doses" are provided. This will be done by allocating time to a warm-up (5 min), an introduction and demonstration of the activity (5 min), the PA (30 min), cool down and stretching (5 min). Time will also be devoted for interaction to develop rapport, transition to the next activity, and to handle internet connectivity issues (15 min). | Behavioural | Physical Activity (PA) Round 1, Physical Activity Round 2 |
Primary outcome
Enrollment
Time frame: Tracked at the time of enrollment
The number of enrolled patients
Duration in minutes
Time frame: Duration (minutes) will be measured each session up to 12 weeks.
The investigators will determine if the delivery of a virtual physical activity program is feasible by tracking the number of minutes spent in the warm up, activity and cool-down.
Heart Rate
Time frame: Intensity ( heart rate) will be measured each session up to 12 weeks.
In order to objectively measure the intensity level and volume of PA during the activity sessions, participants will wear accelerometers on their waist and a wrist-based heart rate will be used to intensity of PA in real-time.
Relative Rate of Perceived Exertion
Time frame: Intensity (RPE) will be measured each session up to 12 weeks.
Rate of perceived exertion (RPE) will be obtained from participants as a subjective measure of intensity.
Acceptability of the program by patients
Time frame: Focus groups will be conducted up to 12 weeks.
The virtual activities also need to enjoyable, so with the use of focus groups, patient acceptability of the program will be determined. Predetermined questions and prompts will be used, such as, "Describe a lesson or lessons you liked best. What are some lessons that were less enjoyable? What was the most difficult aspect of participating in PePA? In general, did the exercises feel like they provided the right amount of exertion, too intense, not intense enough? Was the duration of each session too long, too short or about right?". The focus group recording will be transcribed and themes will be identified in this qualitative analysis.
Adherence
Time frame: Attendance will be measured each week up to 12 weeks. If the participant continues for a second round, adherence will be measured each week during the second intervention up to 12 weeks.
The number of completing patients. This will be measured by counting the number of participants who completed the majority of the program for each round (i.e., 20 out of 24 sessions).
11 secondary outcomes
Health-related quality of life (QL)
Time frame: Change from baseline QL at 12 weeks.
Physical Activity Intention
Time frame: Change from baseline physical activity intention at 12 weeks.
Social Support
Time frame: Change from baseline Social Support at 12 weeks.
Fatigue
Time frame: Change from baseline Fatigue at 12 weeks.
Depression
Time frame: Change from baseline Depression at 12 weeks.
Cardiorespiratory endurance
Time frame: Change from baseline Cardiorespiratory Endurance at 12 weeks.
Flexibility
Time frame: Change from baseline Flexibility at 12 weeks.
Hand Strength
Time frame: Change from baseline Hand Strength at 12 weeks.
Muscular Strength
Time frame: Change from baseline Muscular Strength at 12 weeks.
Balance
Time frame: Change from baseline Balance at 12 weeks.
Activity of daily living (ADL)
Time frame: Change from baseline ADL at 12 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 21 Nov 2023.
- Background: PubMed 31407493Ouyang N, Cai R, Zhou X, Huang H, Qiu X, Liu K. Effects of a group-based physical activity program for pediatric patients with cancer on physical activity and symptom experience: A quasi-experimental study. Pediatr Blood Cancer. 2019 Nov;66(11):e27965. doi: 10.1002/pbc.27965. Epub 2019 Aug 12.
- Background: PubMed 19168920Honas JJ, Washburn RA, Smith BK, Greene JL, Cook-Wiens G, Donnelly JE. The System for Observing Fitness Instruction Time (SOFIT) as a measure of energy expenditure during classroom-based physical activity. Pediatr Exerc Sci. 2008 Nov;20(4):439-45. doi: 10.1123/pes.20.4.439.
- Background: PubMed 11932914Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
- Background: PubMed 24038960Panepinto JA, Torres S, Bendo CB, McCavit TL, Dinu B, Sherman-Bien S, Bemrich-Stolz C, Varni JW. PedsQL Multidimensional Fatigue Scale in sickle cell disease: feasibility, reliability, and validity. Pediatr Blood Cancer. 2014 Jan;61(1):171-7. doi: 10.1002/pbc.24776. Epub 2013 Sep 13.
- Background: PubMed 17057441Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.
- Background: PubMed 23863415Quatman-Yates CC, Gupta R, Paterno MV, Schmitt LC, Quatman CE, Ittenbach RF. Internal consistency and validity of the QuickDASH instrument for upper extremity injuries in older children. J Pediatr Orthop. 2013 Dec;33(8):838-42. doi: 10.1097/BPO.0b013e3182a00688.
- Background: PubMed 34398076Rider BC, Conger SA, Ditzenberger GL, Besteman SS, Bouret CM, Coughlin AM. Examining the Accuracy of the Polar A360 Monitor. J Strength Cond Res. 2021 Aug 1;35(8):2165-2169. doi: 10.1519/JSC.0000000000003136.
- Results publicationYamada PM, Centeio EC, Bantum EO, Cao S, Lopez GM. Informing the delivery of physical activity leadership for pediatric patients undergoing cancer treatment. International Journal of Kinesiology in Higher Education, Sept 2023. DOI: 10.1080/24711616.2023.2237427
- Individual participant dataSharing planned: Undecided. Since the number of subjects that will is small (n=12), IPD may be easily tracked to the patient themselves. If it is possible to mask / de-identify data, IPD may be shared at the conclusion of this study.
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Knowledge, Attitudes, Practice
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.
Paulette Yamada Tamashiro, PhD principal investigator
University of Hawaii
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer and Physical Activity, run by University of Hawaii at 3 sites 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 5 inclusion and 3 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 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Enrollment (time frame: Tracked at the time of enrollment). The study lists 6 primary outcomes in all. 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 NCT06012825, which also lists 8 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 21 Nov 2023.