NeoplasmsNCT02899117
Yoga Intervention to Improve Pediatric Cancer Patients' Sleep & Life Quality and Parents' Well-Being
A study testing Yoga in people with Neoplasms, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
The proposed project will examine feasibility and preliminary efficacy of a yoga intervention in the pediatric oncology unit at Connecticut Children's Medical Center (CCMC) and includes two parts: (1) a survey of children and parents regarding preferences (e.g., convenient days/times), experiences and expectations… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jan 2017
- 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
- Parents and children (ages 8-18) undergoing treatment (chemotherapy and/or radiation therapy) for cancer.
- Cancer diagnosis, between the ages of 8-18 year, English speaking, and medically cleared to participate in yoga.
- Parents will be eligible if they are over 18 years old, English speaking, and physically able to participate in yoga.
Who cannot join
- Children and parents not meeting inclusion criteria
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: Pilot Yoga Intervention to Improve Pediatric Cancer Patients' Sleep & Life Quality and Parents' Well-Being
The proposed project will examine feasibility and preliminary efficacy of a yoga intervention in the pediatric oncology unit at Connecticut Children's Medical Center (CCMC) and includes two parts: (1) a survey of children and parents regarding preferences (e.g., convenient days/times), experiences and expectations regarding yoga (including barriers and positive expectancies) and (2) an eight week clinical trial of a yoga intervention in 10 pairs of children and parents.
Read the detailed description
The specific aims and hypotheses for this seed grant are to collect and assess data on:
Aim 1 feasibility - perceived barriers/solutions, interest and accrual rates, attendance per session, participant retention, evidence of institutional support and resource commitment Hypothesis 1: A yoga intervention is feasible among pediatric oncology patients and their parents; (2) preliminary efficacy - including effect sizes for calculating power Hypothesis 2a: A yoga intervention improves pediatric oncology patients' fatigue, QOL, and sleep.
Hypothesis 2b: A yoga intervention improves parental QOL and caregiver burden.
We will be using the following questionnaires and scales to help answer the quesitons related to the hypotheses and aims:
PedsQL 4.0 PedsQL 3.0 Cancer Module The Fatigue Scale SleepDiary Actigraphy data. Child Home Yoga Practice Diary Satisfaction survey
Questionnaires noted below are given only to the parents:
SF-12 Zarit Caregiver Burden Index Yoga Satisfaction Survey
Study participants will have 4 yoga sessions and the questionnaires and surveys are done prior to the first yoga session and after the last yoga session.
The yoga sessions are created with both the study participant and a certified yoga instructor. The patients are given the yoga routine to practice at home at their leisure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
There are 4 yoga sessions completed with a certified instructor during cancer treatment
| Study group | Role | What they receive |
|---|---|---|
| Yoga intervention | Experimental | Patients in the yoga intervention group will have 4 yoga sessions with a certified yoga instructor while they are in the cancer clinic or on the inpatient floor. Receives: Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of yoga intervention, perceived barriers/solutions
The data will be assessed on perceived barriers/solutions.
Measured: Change from baseline barriers/solutions at 8 weeks post baseline visit
Assess level of interest utlizing data from the Yoga satisfaction survey
Data will be assessed by level of interest utilizing data from the yoga satisfcation survey. Most responses will be on a Likert scale while some specific questions will be other formats (i.e. open ended questions). These questions will help to inform the intervention.
Measured: Data collected at baseline and 8 weeks post baseline visit
Feasibility of yoga intervention, assessed by study accrual rates
Data will be assessed by accrual rates
Measured: Baseline and 8 weeks post baseline visit
Feasibility of yoga intervention, assessed by study visit attendance
Data will be assessed by study visit attendance
Measured: Baseline and 8 weeks post baseline visit
Feasibility of yoga intervention, assessed by study patient retention
Data will be assessed by the number of patients who remain in the study
Measured: Baseline and 8 weeks post baseline visit
Feasibility of yoga intervention, assessed by institutional support
Data will be reviewed for evidence of institutional support
Measured: Baseline and 8 weeks post baseline visit
Feasibility of yoga intervention, assessed by institutional commitment of resources.
Data will be reviewed for institutional resource commitment
Measured: Assessments are collected at baseline and 8 weeks post baseline visit
Secondary outcomes (5)
Improvement in sleep of Patient
Sleep will be assessed via diary of sleep and actigraphy
Measured: Assessments are collected at baseline and 8 weeks post baseline visit
Improvement in quality of life Patient
Quality of life will be assessed by PedsQL 4.0 and PedsQL 3.0 Cancer Module.
Measured: Assessments are collected at baseline and 8 weeks post baseline visit
Improvement in fatigue of Patient
Fatigue will be assessed by the Fatigue Scale (FS). The Fatigue Scale for children (FS-C) between 8-12 years and the Fatigue Scale for adolescent (FS-A) between 13-18 years.
Measured: Assessments are collected at baseline and 8 weeks post baseline visit
Improvement in quality of life of Parent
Parent quality of life will be assessed by the SF-12.
Measured: Assessments are collected at baseline and 8 weeks post baseline visit
Improvement in caregiver burden of Parent.
Caregiver burden will be assessed by the Zarit Caregiver Burden Index
Measured: Assessments are collected at baseline and 8 weeks post baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startAug 2014
- Primary completionOct 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- 23 participants (actual)
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 Childrens Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899117
- Sponsor's protocol ID
- Pilot Yoga 1
- Status last verified
- Feb 2017
- First submitted
- 23 Aug 2016
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Yoga Intervention to Improve Pediatric Cancer Patients' Sleep & Life Quality and Parents' Well-Being
- ClinicalTrials.gov ID
- NCT02899117
- Acronym / sponsor ID
- Pilot Yoga 1
- Conditions
- Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 14 Sep 2016 (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 proposed project will examine feasibility and preliminary efficacy of a yoga intervention in the pediatric oncology unit at Connecticut Children's Medical Center (CCMC) and includes two parts: (1) a survey of children and parents regarding preferences (e.g., convenient days/times), experiences and expectations regarding yoga (including barriers and positive expectancies) and (2) an eight week clinical trial of a yoga intervention in 10 pairs of children and parents.
Detailed description
The specific aims and hypotheses for this seed grant are to collect and assess data on:
Aim 1 feasibility - perceived barriers/solutions, interest and accrual rates, attendance per session, participant retention, evidence of institutional support and resource commitment Hypothesis 1: A yoga intervention is feasible among pediatric oncology patients and their parents; (2) preliminary efficacy - including effect sizes for calculating power Hypothesis 2a: A yoga intervention improves pediatric oncology patients' fatigue, QOL, and sleep.
Hypothesis 2b: A yoga intervention improves parental QOL and caregiver burden.
We will be using the following questionnaires and scales to help answer the quesitons related to the hypotheses and aims:
PedsQL 4.0 PedsQL 3.0 Cancer Module The Fatigue Scale SleepDiary Actigraphy data. Child Home Yoga Practice Diary Satisfaction survey
Questionnaires noted below are given only to the parents:
SF-12 Zarit Caregiver Burden Index Yoga Satisfaction Survey
Study participants will have 4 yoga sessions and the questionnaires and surveys are done prior to the first yoga session and after the last yoga session.
The yoga sessions are created with both the study participant and a certified yoga instructor. The patients are given the yoga routine to practice at home at their leisure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga intervention | Experimental | Other: YogaPatients in the yoga intervention group will have 4 yoga sessions with a certified yoga instructor while they are in the cancer clinic or on the inpatient floor. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Parents and children (ages 8-18) undergoing treatment (chemotherapy and/or radiation therapy) for cancer.
- Cancer diagnosis, between the ages of 8-18 year, English speaking, and medically cleared to participate in yoga.
- Parents will be eligible if they are over 18 years old, English speaking, and physically able to participate in yoga.
Key exclusion criteria (1 listed)
- Children and parents not meeting inclusion criteria
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 |
|---|---|---|
| YogaThere are 4 yoga sessions completed with a certified instructor during cancer treatment | Other | Yoga intervention |
Primary outcome
Feasibility of yoga intervention, perceived barriers/solutions
Time frame: Change from baseline barriers/solutions at 8 weeks post baseline visit
The data will be assessed on perceived barriers/solutions.
Assess level of interest utlizing data from the Yoga satisfaction survey
Time frame: Data collected at baseline and 8 weeks post baseline visit
Data will be assessed by level of interest utilizing data from the yoga satisfcation survey. Most responses will be on a Likert scale while some specific questions will be other formats (i.e. open ended questions). These questions will help to inform the intervention.
Feasibility of yoga intervention, assessed by study accrual rates
Time frame: Baseline and 8 weeks post baseline visit
Data will be assessed by accrual rates
Feasibility of yoga intervention, assessed by study visit attendance
Time frame: Baseline and 8 weeks post baseline visit
Data will be assessed by study visit attendance
Feasibility of yoga intervention, assessed by study patient retention
Time frame: Baseline and 8 weeks post baseline visit
Data will be assessed by the number of patients who remain in the study
Feasibility of yoga intervention, assessed by institutional support
Time frame: Baseline and 8 weeks post baseline visit
Data will be reviewed for evidence of institutional support
Feasibility of yoga intervention, assessed by institutional commitment of resources.
Time frame: Assessments are collected at baseline and 8 weeks post baseline visit
Data will be reviewed for institutional resource commitment
5 secondary outcomes
Improvement in sleep of Patient
Time frame: Assessments are collected at baseline and 8 weeks post baseline visit
Improvement in quality of life Patient
Time frame: Assessments are collected at baseline and 8 weeks post baseline visit
Improvement in fatigue of Patient
Time frame: Assessments are collected at baseline and 8 weeks post baseline visit
Improvement in quality of life of Parent
Time frame: Assessments are collected at baseline and 8 weeks post baseline visit
Improvement in caregiver burden of Parent.
Time frame: Assessments are collected at baseline and 8 weeks post baseline visit
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 17 Feb 2017.
- Individual participant dataSharing planned: No
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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 Childrens 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 Yoga in people with Neoplasms, 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 3 inclusion and 1 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 17 Feb 2017. 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?
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 of yoga intervention, perceived barriers/solutions (time frame: Change from baseline barriers/solutions at 8 weeks post baseline visit). The study lists 7 primary outcomes in all. 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 17 Feb 2017.