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NCT Number: NCT05314803

Yoga for Young Adults Affected by Cancer

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Previous enrolment in the study, to avoid contamination and/or ceiling effects.

Treatment and study plan

Yoga

Behavioral

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.

Primary outcomes

  1. Reach

    Time frame: Through study completion, an average of 5 years

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

Secondary outcomes

  1. Attendance

    Time frame: Through study completion, an average of 5 years

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

  2. Adherence

    Time frame: Through study completion, an average of 5 years

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

  3. Missing data

    Time frame: Through study completion, an average of 5 years

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

  4. Barriers and facilitators to exercise participation

    Time frame: Baseline (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.

  5. Physical activity levels

    Time frame: Baseline (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.

  6. Fatigue

    Time frame: Baseline (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.

  7. Cognition

    Time frame: Baseline (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.

  8. Cancer-related symptoms

    Time frame: Baseline (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.

  9. General health-related quality of life

    Time frame: Baseline (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.

  10. General well-being

    Time frame: Baseline (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.

  11. Mindfulness

    Time frame: Baseline (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.

  12. Self-compassion

    Time frame: Baseline (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.

  13. Stress

    Time frame: Baseline (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.

  14. Group identification

    Time frame: Post-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.

  15. Balance

    Time frame: Baseline (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).

  16. Shoulder range of motion

    Time frame: Baseline (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).

  17. Lower extremity flexibility

    Time frame: Baseline (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).

  18. Functional performance

    Time frame: Baseline (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).

  19. Aerobic endurance

    Time frame: Baseline (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).

  20. Adverse events

    Time frame: Through 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.

  21. Time to implement and deliver

    Time frame: Through study completion, an average of 5 years

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

  22. Yoga program fidelity

    Time frame: Through 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Wurz, PhD

CONTACT

[email protected]

604-504-7441 ext. 2846

S. Nicole Culos-Reed, PhD

CONTACT

[email protected]

403-220-7540

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Canadian Cancer Society (CCS)
  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Apr 6, 2022
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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