FatigueNCT02105389
Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy
A study testing Individualized Yoga Intervention in people with Fatigue, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Cancer-related fatigue (CRF) is a major problem in children, adolescents and adults receiving treatment for cancer, and intensively treated patients may be at higher risk. While exercise is an effective intervention for CRF, patients receiving the most intensive chemotherapy may frequently be too ill to participate in… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Fatigue
- What is being tested?
- Individualized Yoga Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Oct 2013
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with any acute myeloid leukemia (AML), relapsed acute lymphoblastic leukemia, stage 3 or 4 Burkitt's lymphoma/leukemia or about to receive autologous or allogeneic haematopoietic stem cell transplantation (HSCT)
- Expected to be an inpatient for at least three weeks after initiation of chemotherapy or conditioning
- Ages 7 to 18 years of age at enrollment
Who cannot join
- Features present to an extent that would preclude compliance with yoga (as assessed by the attending physician): a) motor disability, b) cognitive disability, c) cardiopulmonary symptoms, or d) known compression fracture resulting in disability
- Parent or patient cannot understand English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy
Cancer-related fatigue (CRF) is a major problem in children, adolescents and adults receiving treatment for cancer, and intensively treated patients may be at higher risk. While exercise is an effective intervention for CRF, patients receiving the most intensive chemotherapy may frequently be too ill to participate in a standardized exercise program. A unique intervention that combines exercise and relaxation is yoga. This pilot study will evaluate the feasibility of three times weekly yoga sessions administered by a trained yoga instructor for a three week duration and will enroll between 10 and 20 children. If feasible, the intervention will be tested in a randomized controlled trial.
- Conditions
- Fatigue
- Being tested
- Individualized Yoga Intervention
- Keywords
- fatigue, quality of life, chemotherapy, haematopoietic stem cell transplantation, children, pilot, yoga
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Yoga InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Individualized Yoga Intervention | Experimental | Individualized Yoga Intervention sessions will be administered by a trained yoga instructor three times weekly (or up to a maximum of five times per week) for three consecutive weeks. There will be a common structure for all sessions that will include relaxation and breathing exercises as well as a series of poses focused on strengthening, flexibility, and balance. There will be low, moderate and high intensity regimens prescribed depending on the wishes and abilities of the child and parent and the judgment of the yoga instructor. Receives: Behavioral: Individualized Yoga Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
To determine feasibility of a 3 times weekly, 3 week yoga intervention for hospitalized children receiving intensive chemotherapy ± radiation by determining the number of children who can complete at least 60% of scheduled yoga sessions for consenting individuals.
We will consider the ability to administer 60% of planned yoga sessions over a 3 week period as feasible (in other words, a minimum of 6 of 9 planned sessions) and anticipate that at least 70% of participants should be able to achieve this level of adherence.
We planned to enroll a minimum of 10 and a maximum of 20 patients and believe the final sample size (11 participants) provides sufficient information to know whether the intervention and measurements are appropriate.
Measured: baseline
Secondary outcomes (1)
Fatigue and Quality of Life outcomes
To describe changes over the intervention period according to: 1) Parent/guardian proxy-report fatigue using the FS-P (Fatigue Scale-Parent) and PedsQL MFM (PedsQL Multidimensional Fatigue Module) and child self-report fatigue using the FS-C/FS-A (Fatigue Scale-Child/Adolescent) and PedsQL MFM; 2) Child QoL using the PedsQL Acute Cancer Module; 3) Parent QoL using the SF-36 (Short Form 36); 4) Acceptability of the yoga intervention according to parents and children; 5) Qualitatively, any aspects of the intervention or measurement that can be improved. We have chosen to focus on a small number of key endpoints to preserve the feasibility of the pilot and future RCT as incorporation of a large number of endpoints would likely result in greater non-compliance in outcome ascertainment. The secondary analyses will all be descriptive. Variability and change in outcome measures in this study will be used to assess the sample size required in the design of a future efficacy trial.
Measured: Change from baseline to day 7, 14 and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startJan 2013
- Primary completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lillian Sung, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105389
- Sponsor's protocol ID
- Yoga Pilot
- Status last verified
- Nov 2015
- First submitted
- 28 Mar 2014
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Diorio C, Schechter T, Lee M, O'Sullivan C, Hesser T, Tomlinson D, Piscione J, Armstrong C, Tomlinson G, Sung L. A pilot study to evaluate the feasibility of individualized yoga for inpatient children receiving intensive chemotherapy. BMC Complement Altern Med. 2015 Jan 24;15:2. doi: 10.1186/s12906-015-0529-3.
PubMed 25617154
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy
- ClinicalTrials.gov ID
- NCT02105389
- Acronym / sponsor ID
- Yoga Pilot
- Conditions
- Fatigue
- Keywords
- fatigue, quality of life, chemotherapy, haematopoietic stem cell transplantation, children, pilot, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- First posted
- 7 Apr 2014 (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.
Cancer-related fatigue (CRF) is a major problem in children, adolescents and adults receiving treatment for cancer, and intensively treated patients may be at higher risk. While exercise is an effective intervention for CRF, patients receiving the most intensive chemotherapy may frequently be too ill to participate in a standardized exercise program. A unique intervention that combines exercise and relaxation is yoga. This pilot study will evaluate the feasibility of three times weekly yoga sessions administered by a trained yoga instructor for a three week duration and will enroll between 10 and 20 children. If feasible, the intervention will be tested in a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized Yoga Intervention | Experimental | Behavioral: Individualized Yoga InterventionIndividualized Yoga Intervention sessions will be administered by a trained yoga instructor three times weekly (or up to a maximum of five times per week) for three consecutive weeks. There will be a common structure for all sessions that will include relaxation and breathing exercises as well as a series of poses focused on strengthening, flexibility, and balance. There will be low, moderate and high intensity regimens prescribed depending on the wishes and abilities of the child and parent and the judgment of the yoga instructor. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosed with any acute myeloid leukemia (AML), relapsed acute lymphoblastic leukemia, stage 3 or 4 Burkitt's lymphoma/leukemia or about to receive autologous or allogeneic haematopoietic stem cell transplantation (HSCT)
- Expected to be an inpatient for at least three weeks after initiation of chemotherapy or conditioning
- Ages 7 to 18 years of age at enrollment
Key exclusion criteria (2 listed)
- Features present to an extent that would preclude compliance with yoga (as assessed by the attending physician): a) motor disability, b) cognitive disability, c) cardiopulmonary symptoms, or d) known compression fracture resulting in disability
- Parent or patient cannot understand English
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 |
|---|---|---|
| Individualized Yoga Intervention | Behavioural | Individualized Yoga Intervention |
Primary outcome
Feasibility of recruitment
Time frame: baseline
To determine feasibility of a 3 times weekly, 3 week yoga intervention for hospitalized children receiving intensive chemotherapy ± radiation by determining the number of children who can complete at least 60% of scheduled yoga sessions for consenting individuals. We will consider the ability to administer 60% of planned yoga sessions over a 3 week period as feasible (in other words, a minimum of 6 of 9 planned sessions) and anticipate that at least 70% of participants should be able to achieve this level of adherence. We planned to enroll a minimum of 10 and a maximum of 20 patients and believe the final sample size (11 participants) provides sufficient information to know whether the intervention and measurements are appropriate.
1 secondary outcome
Fatigue and Quality of Life outcomes
Time frame: Change from baseline to day 7, 14 and 21
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 30 Nov 2015.
- Derived from this study: PubMed 25617154Diorio C, Schechter T, Lee M, O'Sullivan C, Hesser T, Tomlinson D, Piscione J, Armstrong C, Tomlinson G, Sung L. A pilot study to evaluate the feasibility of individualized yoga for inpatient children receiving intensive chemotherapy. BMC Complement Altern Med. 2015 Jan 24;15:2. doi: 10.1186/s12906-015-0529-3.
Related trials for Fatigue
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
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?
A study testing Individualized Yoga Intervention in people with Fatigue, run by The Hospital for Sick Children at 1 site in Canada.
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 2 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 30 Nov 2015. 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 Canada. 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 recruitment (time frame: baseline). 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 NCT02105389, which also lists 1 linked publication.
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 30 Nov 2015.