Quality of LifeY-ACTNCT02309112
Yoga in Adult Cancer: A Feasibility Trial
A study testing Yoga in people with Quality of Life, run by University of Oxford.
Trial summary
A feasibility study to determine the appropriateness of yoga intervention to improve health-related quality of life in adult cancer patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adult cancer patients 19 years of age or older
- Patients receiving or planning to receive conventional treatment that includes at least one of chemotherapy, radiotherapy, hormone therapy or active surveillance within 28 days
- Patients in any stage of cancer diagnoses of all tumour types and locations
- Participants with internet access and willingness to participate in online communication
- Participants with access to transportation and personal willingness to attend meetings in central Vancouver, Canada.
- Participants fluent in the English language
Who cannot join
- Patients with any physical limitation, risk of personal injury or under proscription of light to moderate physical activity
- Patients with pre or post surgical interventions were excluded due to potential physical limitations or safety concerns with wound healing
- Regular or experienced practitioners of yoga were excluded and defined as those patients reporting current or historical use of regular yoga (>2 session per month in past 12 months)
- Patients undergoing medical treatment for serious psychological disturbances that might have interfered with adherence to protocol and/or ability to provide informed consent were excluded (e.g. multiple personality disorders, severe depression, obsessive-compulsive disorder)
About this study
Official title: Yoga for Health-related Quality of Life in Adult Cancer: A Randomized Controlled Feasibility Trial
A feasibility study to determine the appropriateness of yoga intervention to improve health-related quality of life in adult cancer patients.
Read the detailed description
A prospective, mixed methods feasibility trial allocated participants to receive one of three yoga interventions over a four-week study period. Data collection was completed through online survey of QOL-CA/CS and customized surveys.
- Conditions
- Quality of Life
- Being tested
- Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
A mind-body therapy that includes specified breathing, meditation and physical postures.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Group A: Minimum Exposure | Experimental | The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. In Week 1, this session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class. Receives: Other: Yoga |
| Yoga Group B: Medium Exposure | Experimental | The medium-exposure yoga package, this intervention included the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in Week 1. Participants were then invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study (Weeks 1 to 4). In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during Week 2 or 3. Receives: Other: Yoga |
| Yoga Group C: Maximum Exposure | Experimental | The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in Week 1. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study (Weeks 1 to 4). Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (Weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient. Receives: Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Patient Recruitment to Yoga Intervention
Number of participants eligible for randomization to yoga intervention during cancer treatment
Measured: 10 weeks
Secondary outcomes (2)
Patient Adherence to Yoga Intervention
Number of participants who completed their yoga intervention
Measured: 6 weeks
Patient Adherence Rate to Yoga Intervention
% of patients who completed their yoga intervention
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, British Columbia Cancer Agency
- Responsible party
- Sponsor
- Investigators
- Melanie McDonald, MSW, Principal investigator, Vancouver-BCCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309112
- Sponsor's protocol ID
- OXTREC 534-14
- Acronym
- Y-ACT
- Status last verified
- Nov 2014
- First submitted
- 21 Nov 2014
- Last updated
- 10 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McCall M, McDonald M, Thorne S, Ward A, Heneghan C. Yoga for Health-Related Quality of Life in Adult Cancer: A Randomized Controlled Feasibility Study. Evid Based Complement Alternat Med. 2015;2015:816820. doi: 10.1155/2015/816820. Epub 2015 Jun 11.
PubMed 26170884
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga for Health-related Quality of Life in Adult Cancer: A Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT02309112
- Acronym / sponsor ID
- Y-ACT / OXTREC 534-14
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of British Columbia, British Columbia Cancer Agency
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Posted 10 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A feasibility study to determine the appropriateness of yoga intervention to improve health-related quality of life in adult cancer patients.
Detailed description
A prospective, mixed methods feasibility trial allocated participants to receive one of three yoga interventions over a four-week study period. Data collection was completed through online survey of QOL-CA/CS and customized surveys.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga Group A: Minimum Exposure | Experimental | Other: YogaThe minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. In Week 1, this session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class. |
| Yoga Group B: Medium Exposure | Experimental | Other: YogaThe medium-exposure yoga package, this intervention included the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in Week 1. Participants were then invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study (Weeks 1 to 4). In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during Week 2 or 3. |
| Yoga Group C: Maximum Exposure | Experimental | Other: YogaThe maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in Week 1. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study (Weeks 1 to 4). Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (Weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female adult cancer patients 19 years of age or older
- Patients receiving or planning to receive conventional treatment that includes at least one of chemotherapy, radiotherapy, hormone therapy or active surveillance within 28 days
- Patients in any stage of cancer diagnoses of all tumour types and locations
- Participants with internet access and willingness to participate in online communication
- Participants with access to transportation and personal willingness to attend meetings in central Vancouver, Canada.
Key exclusion criteria (4 listed)
- Patients with any physical limitation, risk of personal injury or under proscription of light to moderate physical activity
- Patients with pre or post surgical interventions were excluded due to potential physical limitations or safety concerns with wound healing
- Regular or experienced practitioners of yoga were excluded and defined as those patients reporting current or historical use of regular yoga (>2 session per month in past 12 months)
- Patients undergoing medical treatment for serious psychological disturbances that might have interfered with adherence to protocol and/or ability to provide informed consent were excluded (e.g. multiple personality disorders, severe depression, obsessive-compulsive disorder)
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 |
|---|---|---|
| YogaA mind-body therapy that includes specified breathing, meditation and physical postures. | Other | Yoga Group A: Minimum Exposure, Yoga Group B: Medium Exposure, Yoga Group C: Maximum Exposure |
Primary outcome
Feasibility of Patient Recruitment to Yoga Intervention
Time frame: 10 weeks
Number of participants eligible for randomization to yoga intervention during cancer treatment
2 secondary outcomes
Patient Adherence to Yoga Intervention
Time frame: 6 weeks
Patient Adherence Rate to Yoga Intervention
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26170884McCall M, McDonald M, Thorne S, Ward A, Heneghan C. Yoga for Health-Related Quality of Life in Adult Cancer: A Randomized Controlled Feasibility Study. Evid Based Complement Alternat Med. 2015;2015:816820. doi: 10.1155/2015/816820. Epub 2015 Jun 11.
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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.
Melanie McDonald, MSW principal investigator
Vancouver-BCCA
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Quality of Life, run by University of Oxford.
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 6 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: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 10 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Patient Recruitment to Yoga Intervention (time frame: 10 weeks). 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 NCT02309112, 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 10 Feb 2015.