MedPath

Yoga for Young Adults Affected by Cancer

Not Applicable
Recruiting
Conditions
Young Adult Cancer
Young Adult Oncology
Interventions
Behavioral: Yoga
Registration Number
NCT05314803
Lead Sponsor
University of Calgary
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
500
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
YogaYogaParticipants receive online, group-based yoga classes 2 times/week for 60 minutes/class over 12 weeks.
Primary Outcome Measures
NameTimeMethod
ReachThrough study completion, an average of 5 years

The number of people who participate, and reasons why or why not.

Secondary Outcome Measures
NameTimeMethod
AttendanceThrough study completion, an average of 5 years

Number of classes attended out of the number of classes offered by study staff.

Adverse eventsThrough study completion, an average of 5 years

Adverse events will be defined as any negative effect caused (or suspected to be caused by) the yoga program.

AdherenceThrough study completion, an average of 5 years

Number of classes attended out of the number of classes offered by study staff.

Missing dataThrough study completion, an average of 5 years

Percentage of missing data on quantitative measures and completion of qualitative interviews.

Physical activity levelsBaseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

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.

FatigueBaseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

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.

CognitionBaseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

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.

Group identificationPost-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

Change in Group Identification Scale (11). Scale range 1-7; higher scores indicate greater identification with the group.

BalanceBaseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

Change in one legged stance test (seconds) (see 12).

Functional performanceBaseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

Change in sit-to-stand (number of repetitions in 30 seconds) (see 12).

MindfulnessBaseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

Change in Mindful Attention Awareness Scale (8). Scale range 1-6; higher scores indicate higher levels of dispositional mindfulness.

Lower extremity flexibilityBaseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

Change in sit-and-reach test (cm) (see 12).

Yoga program fidelityThrough study completion, an average of 5 years

Fidelity of the physical activity program implementation will be assessed via randomly video-auditing a subset of classes.

Barriers and facilitators to exercise participationBaseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

Change in Barrier Self-Efficacy Scale (1). Scale range 0-100; higher scores indicates less barriers to participation.

General health-related quality of lifeBaseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

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.

Time to implement and deliverThrough study completion, an average of 5 years

Time and expertise to deliver the intervention and physical assessments will be tracked.

Cancer-related symptomsBaseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

Change in Edmonton Symptom Assessment Scale (5). Scale range 0-10; lower scores indicate fewer/less severe symptoms.

General well-beingBaseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

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.

Self-compassionBaseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

Change in Self-Compassion Scale (9). Scale range 1-5; higher scores indicate greater self-compassion.

StressBaseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

Change in Perceived Stress Scale (10). Scale range 0-4; some items are reverse scored; higher scores indicate more perceived stress.

Shoulder range of motionBaseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

Change in active shoulder flexion range of motion (degrees) (see 12).

Aerobic enduranceBaseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

Change in 2 minute step test (steps) results (see 12).

Trial Locations

Locations (1)

University of Calgary

🇨🇦

Calgary, Alberta, Canada

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