Clinical trial NCT05180656: Feasibility of a Remotely-Delivered Yoga Intervention on Cognitive Function in Breast Cancer Survivors
Official title: The Impact of a Remotely-Delivered Yoga Intervention on Cognitive Function in Breast Cancer Survivors: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will participate in two 60-minute virtual yoga classes each week, delivered through videoconferencing for 8 weeks.
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Enrolment rate
timeFrame: From beginning to end of recruitment period, up to 6 months.
measure: Adherence rate
timeFrame: From beginning to end of intervention period, up to 6 months.
measure: Attrition rate
timeFrame: From beginning to end of intervention period, up to 6 months.
measure: Adverse events
timeFrame: From beginning to end of intervention period, up to 6 months.
measure: Burden and satisfaction
timeFrame: 8 weeks post-baseline
Secondary outcomes:
measure: Self-reported cognitive function
timeFrame: Baseline to 8 weeks post-baseline
measure: Objectively-assessed cognitive function
timeFrame: Baseline to 8 weeks post-baseline
measure: Self-reported fatigue
timeFrame: Baseline to 8 weeks post-baseline
measure: Self-reported exercise
timeFrame: Baseline to 8 weeks post-baseline
measure: Semi-structured qualitative interviews
timeFrame: 8 weeks post-baseline
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Faculty of Kinesiology and Physical Education
state: Ontario
Study officials:
affiliation: University of Toronto, Faculty of Kinesiology and Physical Education
name: Linda Trinh, PhD
role: STUDY_DIRECTOR
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