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Yoga for Young Adults Affected by Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05314803
Recruitment Status : Recruiting
First Posted : April 6, 2022
Last Update Posted : April 6, 2022
Sponsor:
Collaborators:
Canadian Cancer Society (CCS)
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Young Adult Cancer Young Adult Oncology Behavioral: Yoga Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 1, 2021
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 1, 2028

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05314803


Contacts
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Contact: S. Nicole Culos-Reed, PhD 403-220-7540 nculosre@ucalgary.ca
Contact: Amanda Wurz, PhD 604-504-7441 ext 2846 amanda.wurz@ufv.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: S. Nicole Culos-Reed, PhD    403-220-7540    nculosre@ucalgary.ca   
Contact: Wellness Lab    403-210-8482    wellnesslab@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
Canadian Cancer Society (CCS)
Canadian Institutes of Health Research (CIHR)
Investigators
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Study Director: S. Nicole Culos-Reed, PhD University of Calgary
Publications:
Wagner L, Sweet J, Butt Z, Lai J-S, Cella D. Measuring patient self-reported cognitive function: development of the functional assessment of cancer therapy-cognitive function instrument. J Support Oncol, 2009. 7(6): W32-W39.
Neff KD. Development and validation of a scale to measure self-compassion. Self Ident, 2003. 2: 223-50.

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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT05314803    
Other Study ID Numbers: HREBA.CC-20-0098 (sub-study)
First Posted: April 6, 2022    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms