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

NCT05180656 | Completed

• 1 other identifier: 41494
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (5)

• Self-reported cognitive function

  Baseline to 8 weeks post-baseline

• Objectively-assessed cognitive function

  Baseline to 8 weeks post-baseline

• Self-reported fatigue

  Baseline to 8 weeks post-baseline

• Self-reported exercise

  Baseline to 8 weeks post-baseline

• Semi-structured qualitative interviews

  8 weeks post-baseline

Study Arms (1)

Yoga Intervention Group

EXPERIMENTAL

All participants will be assigned to the yoga intervention group (single arm).

Behavioral: Yoga Intervention

Interventions

Yoga Intervention BEHAVIORAL

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.

Yoga Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Faculty of Kinesiology and Physical Education

Toronto, Ontario, M5S2W6, Canada

Location

Related Publications (26)

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Linda Trinh, PhD

  University of Toronto, Faculty of Kinesiology and Physical Education

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: N/A - single-arm study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Lab Director

Model Details: Participants will participate in two 60-minute virtual yoga classes each week, delivered through videoconferencing for 8 weeks.

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: January 6, 2022
• Study Start: December 13, 2021
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)