NCT02309112

Brief Summary

A feasibility study to determine the appropriateness of yoga intervention to improve health-related quality of life in adult cancer patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable quality-of-life

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
2 months until next milestone

Results Posted

Study results publicly available

February 10, 2015

Completed
Last Updated

February 10, 2015

Status Verified

November 1, 2014

Enrollment Period

4 months

First QC Date

November 21, 2014

Results QC Date

December 15, 2014

Last Update Submit

February 9, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Patient Recruitment to Yoga Intervention

    Number of participants eligible for randomization to yoga intervention during cancer treatment

    10 weeks

Secondary Outcomes (2)

  • Patient Adherence to Yoga Intervention

    6 weeks

  • Patient Adherence Rate to Yoga Intervention

    6 weeks

Other Outcomes (3)

  • Patient Acceptability of Yoga Intervention

    6 weeks

  • Financial Cost of Delivering Yoga Intervention in a Clinical Setting

    10 weeks

  • Patient's Health-related Quality of Life

    6 weeks

Study Arms (3)

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.

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.

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.

Other: Yoga

Interventions

YogaOTHER

A mind-body therapy that includes specified breathing, meditation and physical postures.

Yoga Group A: Minimum ExposureYoga Group B: Medium ExposureYoga Group C: Maximum Exposure

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Limitations and Caveats

As a feasibility study, the sample size is underpowered and quantitative results are unreliable.

Results Point of Contact

Title
Marcy McCall, Lead Researcher
Organization
University of Oxford

Study Officials

  • Melanie McDonald, MSW

    Vancouver-BCCA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2014

First Posted

December 5, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

February 10, 2015

Results First Posted

February 10, 2015

Record last verified: 2014-11