NCT03460028

Brief Summary

This randomized controlled trial will evaluate a yoga intervention for individuals who experience persistent pain following oncology surgery. The integrated yoga program will involve postures, breathing exercises, and concentration practices. Data will be collected at several time points (pre-, mid-, and post-intervention) for both the intervention and wait-list control conditions. The data will be analysed using linear mixed effects growth models. Results will be written up in manuscript format, published in a peer review journal, and disseminated at scientific research conferences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 17, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

1.2 years

First QC Date

October 17, 2017

Last Update Submit

April 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in scores on the Pain Catastrophizing Scale

    at 0, 4 and 8 weeks

Study Arms (2)

Yoga Condition

EXPERIMENTAL

Participants randomized to the Yoga Condition will participate in a specialized yoga intervention.

Behavioral: Yoga Condition

Wait-List Control Condition

NO INTERVENTION

Participants randomized to the Wait-List Control Condition will participate in a specialized yoga intervention once the Yoga Condition has completed their assigned intervention.

Interventions

Yoga ConditionBEHAVIORAL

Participants randomized to the Yoga Condition will participate in an integrated yoga program consisting of yoga postures, breathing exercises, and concentration/meditation practices.

Yoga Condition

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is a patient at specific pain clinics
  • Has undergone oncology surgery prior to commencing the yoga intervention
  • Is 18 years of age or older
  • Is able to speak and read English
  • Is able to commit to one weekly, one hour yoga classes for eight weeks
  • Is able to provide a note from their physician or kinesiologist indicating that it is safe for them to participate in a gentle physical activity intervention, such as yoga

You may not qualify if:

  • Has pre-existing medical contraindications that preclude participation
  • Has cognitive limitations or language comprehension issues that would impact participation
  • Have had a regular yoga practice in the last six months
  • Documented personality disorder
  • Pregnant women
  • Current enrollment in another research trial evaluating a mind-body intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Study Design

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

Study Record Dates

First Submitted

October 17, 2017

First Posted

March 9, 2018

Study Start

April 1, 2019

Primary Completion

June 1, 2020

Study Completion

March 31, 2021

Last Updated

April 19, 2021

Record last verified: 2021-04

Locations