Clinical trial NCT05314803: Yoga for Young Adults Affected by Cancer
Official title: Yoga for Young Adults Affected by Cancer: Exploring Implementation and Effectiveness of an Online Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Young Adult Cancer
Young Adult Oncology
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-04-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Adult aged 18 years or older;
2. Diagnosed with cancer between the ages of 18-39 years;
3. At any stage of their cancer experience (i.e., on- or off-treatment);
4. Able to safely engage in yoga, as assessed by completing the Get Active Questionnaire and obtaining medical clearance (if indicated).
5. 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.

Primary outcomes:
measure: Reach
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
measure: Attendance
timeFrame: Through study completion, an average of 5 years
measure: Adherence
timeFrame: Through study completion, an average of 5 years
measure: Missing data
timeFrame: Through study completion, an average of 5 years
measure: Barriers and facilitators to exercise participation
timeFrame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: Physical activity levels
timeFrame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: Fatigue
timeFrame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: Cognition
timeFrame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: Cancer-related symptoms
timeFrame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: General health-related quality of life
timeFrame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: General well-being
timeFrame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: Mindfulness
timeFrame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: Self-compassion
timeFrame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: Stress
timeFrame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: Group identification
timeFrame: Post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: Balance
timeFrame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: Shoulder range of motion
timeFrame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: Lower extremity flexibility
timeFrame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: Functional performance
timeFrame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: Aerobic endurance
timeFrame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
measure: Adverse events
timeFrame: Through study completion, an average of 5 years
measure: Time to implement and deliver
timeFrame: Through study completion, an average of 5 years
measure: Yoga program fidelity
timeFrame: Through study completion, an average of 5 years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: S. Nicole Culos-Reed, PhD
role: STUDY_DIRECTOR
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