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
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