Feasibility of a Remotely-Delivered Yoga Intervention on Cognitive Function in Breast Cancer Survivors

January 10, 2023 updated by: Linda Trinh, University of Toronto

The Impact of a Remotely-Delivered Yoga Intervention on Cognitive Function in Breast Cancer Survivors: A Feasibility Study

The purpose of this pilot study is to assess the feasibility of a remotely-delivered yoga intervention for breast cancer survivors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although up to 75% of breast cancer survivors (BCS) experience cancer-related cognitive impairment (CRCI), there are no proven treatments beyond symptom management. Exercise and yoga interventions for cancer survivors have been shown to be effective in improving other treatment-related side effects such as fatigue, quality of life (QoL), and psychological distress, but there remain several gaps in the exercise oncology literature regarding the optimal type and dose of exercise needed to mitigate CRCI. Specifically, no studies have evaluated the impact of yoga on CRCI using both self-report and objective cognitive measures. Further, no studies have evaluated the impact of a remotely-delivered yoga intervention on CRCI in breast cancer survivors.

Using a mixed-methods approach, this study will will begin to fill these gaps by evaluating the feasibility of a remotely-delivery yoga intervention on cancer-related cognitive impairment (CRCI), fatigue, and exercise levels in individuals diagnosed with breast cancer. The primary objective of this study is to assess the feasibility of a remotely-delivered yoga intervention for breast cancer survivors. This study will inform future randomized controlled trials (RCTs) examining the impact of remotely-delivered yoga interventions, with the eventual goal of providing greater access to exercise programming for symptom management for breast cancer patients and survivors.

All aspects of the study, including the assessments and the yoga intervention will take place remotely through videoconferencing. Feasibility measures, including enrolment, adherence, and attrition rates, as well as adverse events and participant satisfaction, will be tracked and assessed throughout the intervention. Objectively-assessed cognitive function will be measured using the National Institutes of Health (NIH) Virtual Toolbox Cognitive Battery and the online PsyToolkit Task Switching Test. Self-reported cognitive function will be assessed using the Functional Assessment of Cancer Therapy(FACT)-Cognitive questionnaire. Self-reported fatigue will be assessed using the Revised-Piper Fatigue Scale (PFS). Self-reported exercise will be assessed using a modified version of the Godin Leisure Time Exercise questionnaire (GLTEQ). These assessments will be taken at baseline and post-intervention. Participants will be asked to participate in the yoga intervention for 8 weeks. The yoga intervention will consist of two 60-minute yoga classes each week, which will be taught by a certified yoga instructor. Following the intervention, a sub-sample of participants will be will be purposefully selected and asked to participate in semi-structured qualitative interviews to understand their experiences with the intervention and study.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S2W6
        • Faculty of Kinesiology and Physical Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥18 years of age
  • primary diagnosis of Stage I-IIIa breast cancer
  • completed primary treatment(s)
  • proficient in written and spoken English
  • access to the Internet and a computer with videoconferencing capabilities

Exclusion Criteria:

  • colour-blind since the objective cognitive tests require participants to distinguish between colours
  • regular yoga practice defined as ≥2 times/week
  • major cognitive disorder(s) or impairment(s) (score ≤21 on the Telephone Interview of Cognitive Status)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga Intervention Group
All participants will be assigned to the yoga intervention group (single arm).
Behavioral: Yoga Intervention
The yoga intervention will consist of two 60-minute yoga classes each week, taught by a certified yoga instructor and delivered remotely through videoconferencing. Participants will be asked to participate in the intervention for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrolment rate
Time Frame: From beginning to end of recruitment period, up to 6 months.
Participant enrolment rate will be one measure of feasibility. This will be calculated as the number of participants who enrol in the intervention, divided by the total number of participants assessed for study eligibility.
From beginning to end of recruitment period, up to 6 months.
Adherence rate
Time Frame: From beginning to end of intervention period, up to 6 months.
Adherence rate, or participants' adherence to the intervention, will be one measure of feasibility. This will be calculated as the number of classes participants attend, divided by the number of classes participants are expected to attend throughout the intervention.
From beginning to end of intervention period, up to 6 months.
Attrition rate
Time Frame: From beginning to end of intervention period, up to 6 months.
Attrition rate, or participant drop-out, will be one measure of feasibility. This will be calculated as the number of participants who do not complete the intervention, divided by the number of participants enrolled at the post-intervention mark.
From beginning to end of intervention period, up to 6 months.
Adverse events
Time Frame: From beginning to end of intervention period, up to 6 months.
Adverse events will be one measure of feasibility. This will be assessed as an unexpected and severe medical problem or injury that occurs during the yoga classes.
From beginning to end of intervention period, up to 6 months.
Burden and satisfaction
Time Frame: 8 weeks post-baseline
Burden and satisfaction scores will be one measure of feasibility. This will be assessed using a researcher-generated 15-item questionnaire that asks participants about their experience with the intervention and assessments. Participants will rate items using a 5-point Likert scale (1 = 'strongly disagree', 5 = 'strongly agree').
8 weeks post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported cognitive function
Time Frame: Baseline to 8 weeks post-baseline
Self-reported cognitive function will be assessed using the 37-item FACT-Cog (Version 3) questionnaire which asks participants about perceived cognitive impairments, comments from others, perceived cognitive abilities, and impact on quality of life. Participants will be asked to rate each item on a 5-point Likert scale (0 = 'never/not at all', 4 = 'several times a day/very much').
Baseline to 8 weeks post-baseline
Objectively-assessed cognitive function
Time Frame: Baseline to 8 weeks post-baseline
Objectively-assessed cognitive function will be measured using the National Institutes of Health (NIH) Toolbox Virtual Cognitive battery to measure immediate and working memory, verbal learning, executive function, and language, and the PsyToolkit task switching test to measure executive function. These tests will be administered remotely to participants via an iPad and videoconferencing.
Baseline to 8 weeks post-baseline
Self-reported fatigue
Time Frame: Baseline to 8 weeks post-baseline
Self-reported fatigue will be assessed using the Revised-Piper Fatigue Scale questionnaire which is a 27-item questionnaire that asks participants about the degree of their perceived fatigue. Participants will be asked to rate each item on a 10-point Likert scale (0 = 'none', 10 = 'very much')
Baseline to 8 weeks post-baseline
Self-reported exercise
Time Frame: Baseline to 8 weeks post-baseline
Self-reported exercise will be assessed using a modified version of the Godin Leisure Time Exercise Questionnaire, which asks participants about the number of times/week and average duration spent in light, moderate, and vigorous exercise in a typical week (7 days) over the past month.
Baseline to 8 weeks post-baseline
Semi-structured qualitative interviews
Time Frame: 8 weeks post-baseline
The researcher will conduct semi-structured qualitative interviews over videoconferencing that will ask participants about their experience with the study and intervention, including enjoyment, potential barriers faced, and how they felt physically and cognitively during and after the intervention.
8 weeks post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Investigators

  • Study Director: Linda Trinh, PhD, University of Toronto, Faculty of Kinesiology and Physical Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2021

Primary Completion (Actual)

July 27, 2022

Study Completion (Actual)

July 27, 2022

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 41494

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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