Yoga for Young Adults Affected by Cancer

Sponsor
University of Calgary (Other)
Overall Status
Recruiting
CT.gov ID
NCT05314803
Collaborator
Canadian Cancer Society (CCS) (Other), Canadian Institutes of Health Research (CIHR) (Other)
500
1
1
87
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Yoga
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Yoga for Young Adults Affected by Cancer: Exploring Implementation and Effectiveness of an Online Program
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2027
Anticipated Study Completion Date :
Dec 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Yoga

Participants receive online, group-based yoga classes 2 times/week for 60 minutes/class over 12 weeks.

Behavioral: Yoga
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.

Outcome Measures

Primary Outcome Measures

  1. Reach [Through study completion, an average of 5 years]

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

Secondary Outcome Measures

  1. Attendance [Through study completion, an average of 5 years]

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

  2. Adherence [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Calgary Calgary Alberta Canada T2N 1N4

Sponsors and Collaborators

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

Investigators

  • Study Director: S. Nicole Culos-Reed, PhD, University of Calgary

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Calgary
ClinicalTrials.gov Identifier:
NCT05314803
Other Study ID Numbers:
  • HREBA.CC-20-0098 (sub-study)
First Posted:
Apr 6, 2022
Last Update Posted:
Apr 6, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022