Yoga for Young Adults Affected by Cancer

Study Overview
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Brief Summary
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Yoga may enhance physical and psychological outcomes among young adults affected by cancer. Yet, yoga has rarely been studied in this population. We developed and piloted a yoga program, which is now ready for implementation and evaluation. This single-group, mixed-methods project will explore effectiveness and implementation of the yoga program.

Official Title
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Yoga for Young Adults Affected by Cancer: Exploring Implementation and Effectiveness of an Online Program

Conditions
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Young Adult Cancer, Young Adult Oncology

Intervention / Treatment
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* Behavioral: Yoga


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult aged 18 years or older; Diagnosed with cancer between the ages of 18-39 years; At any stage of their cancer experience (i.e., on- or off-treatment); Able to safely engage in yoga, as assessed by completing the Get Active Questionnaire and obtaining medical clearance (if indicated). Willing and able to complete informed consent, questionnaires, physical assessments, and an interview in English. Exclusion Criteria: 1. Previous enrolment in the study, to avoid contamination and/or ceiling effects.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br>Participants receive online, group-based yoga classes 2 times/week for 60 minutes/class over 12 weeks. | Behavioral: Yoga<br>* Participants receive the yoga program, which is delivered by a trained yoga instructor (completed at least a 200-hour yoga teacher training, Yoga Thrive Teacher Training Certification (or similar), and/or practical experience working with individuals affected by cancer). The first class of the week is comprised of 45 minutes of gentle, progressive, hatha-based yoga sequencing and postures with the last 15 minutes focused on guided behaviour change and mindfulness techniques that varies week-to-week, based on the participants in the class. The second class of the week is 60 minutes of gentle, yin-based yoga sequencing and postures with an element of opening and relaxing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach | The number of people who participate, and reasons why or why not. | Through study completion, an average of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance | Number of classes attended out of the number of classes offered by study staff. | Through study completion, an average of 5 years | 
| Adherence | Number of classes attended out of the number of classes offered by study staff. | Through study completion, an average of 5 years | 
| Missing data | Percentage of missing data on quantitative measures and completion of qualitative interviews. | Through study completion, an average of 5 years | 
| Barriers and facilitators to exercise participation | Change in Barrier Self-Efficacy Scale (1). Scale range 0-100; higher scores indicates less barriers to participation. | Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| Physical activity levels | Changes in Godin Leisure Time Scale (2). Individuals indicate how many times per week and how long per session they exercise at certain intensity (mild, moderate, high). Higher scores indicate higher levels of physical activity. | Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| Fatigue | Change in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (3). Scale range 0-4; selected items are reverse scored; higher score indicate less fatigue. | Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| Cognition | Changes in Functional Assessment of Cancer Therapy - Cognitive Scale (4). Scale range 1-4; some items are reversed scored; higher scores indicate less cognitive impairment. | Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| Cancer-related symptoms | Change in Edmonton Symptom Assessment Scale (5). Scale range 0-10; lower scores indicate fewer/less severe symptoms. | Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| General health-related quality of life | Change in EuroQual - 5Dimensions (EQ-5D) Scale (6). Scale range 1-5 with lower scores indicating greater quality of life; visual analogue scale range 0-100 with higher scores indicating greater quality of life. | Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| General well-being | Change in Functional Assessment of Cancer Therapy - General Scale (7). Scale range 0-4; selected items are reversed scored; higher scores indicate greater quality of life. | Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| Mindfulness | Change in Mindful Attention Awareness Scale (8). Scale range 1-6; higher scores indicate higher levels of dispositional mindfulness. | Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| Self-compassion | Change in Self-Compassion Scale (9). Scale range 1-5; higher scores indicate greater self-compassion. | Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| Stress | Change in Perceived Stress Scale (10). Scale range 0-4; some items are reverse scored; higher scores indicate more perceived stress. | Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| Group identification | Change in Group Identification Scale (11). Scale range 1-7; higher scores indicate greater identification with the group. | Post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| Balance | Change in one legged stance test (seconds) (see 12). | Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| Shoulder range of motion | Change in active shoulder flexion range of motion (degrees) (see 12). | Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| Lower extremity flexibility | Change in sit-and-reach test (cm) (see 12). | Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| Functional performance | Change in sit-to-stand (number of repetitions in 30 seconds) (see 12). | Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| Aerobic endurance | Change in 2 minute step test (steps) results (see 12). | Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52) | 
| Adverse events | Adverse events will be defined as any negative effect caused (or suspected to be caused by) the yoga program. | Through study completion, an average of 5 years | 
| Time to implement and deliver | Time and expertise to deliver the intervention and physical assessments will be tracked. | Through study completion, an average of 5 years | 
| Yoga program fidelity | Fidelity of the physical activity program implementation will be assessed via randomly video-auditing a subset of classes. | Through study completion, an average of 5 years |