Breast Cancer Clinical Trial
Official title:
The Impact of a Remotely-Delivered Yoga Intervention on Cognitive Function in Breast Cancer Survivors: A Feasibility Study
NCT number | NCT05180656 |
Other study ID # | 41494 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 13, 2021 |
Est. completion date | July 27, 2022 |
Verified date | January 2023 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this pilot study is to assess the feasibility of a remotely-delivered yoga intervention for breast cancer survivors.
Status | Completed |
Enrollment | 18 |
Est. completion date | July 27, 2022 |
Est. primary completion date | July 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Canada | Faculty of Kinesiology and Physical Education | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto |
Canada,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Enrolment rate | 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. | |
Primary | Adherence rate | 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. | |
Primary | Attrition rate | 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. | |
Primary | Adverse events | 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. | |
Primary | Burden and satisfaction | 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 | Self-reported cognitive function | 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 | |
Secondary | Objectively-assessed cognitive function | 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 | |
Secondary | Self-reported fatigue | 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 | |
Secondary | Self-reported exercise | 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 | |
Secondary | Semi-structured qualitative interviews | 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 |
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