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RecruitingNCT05314803Updated Apr 6, 2022

Yoga for Young Adults Affected by Cancer

An interventional study of Yoga in Young Adult Cancer and Young Adult Oncology, sponsored by University of Calgary. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-06.

Sponsored by University of Calgary · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Sep 2021, registered Mar 2022).
  • Started Sep 2021; still recruiting 5 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Young Adult Cancer
  • Young Adult Oncology

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 500 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  1. Previous enrolment in the study, to avoid contamination and/or ceiling effects.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Yoga

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

    Behavioral: Yoga

Interventions

  • BehavioralYoga

    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.

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What researchers measure

Primary outcomes

  1. Reach

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

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

Secondary outcomes

  1. Attendance

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

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

  2. Adherence

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

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

  3. Missing data

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

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

  4. Barriers and facilitators to exercise participation

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

    Time frame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

  5. Physical activity levels

    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.

    Time frame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

  6. Fatigue

    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.

    Time frame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

  7. Cognition

    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.

    Time frame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

  8. Cancer-related symptoms

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

    Time frame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

  9. General health-related quality of life

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

  10. General well-being

    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.

    Time frame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

  11. Mindfulness

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

    Time frame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

  12. Self-compassion

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

    Time frame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

  13. Stress

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

    Time frame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

  14. Group identification

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

    Time frame: Post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

  15. Balance

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

    Time frame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

  16. Shoulder range of motion

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

    Time frame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

  17. Lower extremity flexibility

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

    Time frame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

  18. Functional performance

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

    Time frame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

  19. Aerobic endurance

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

    Time frame: Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)

  20. Adverse events

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

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

  21. Time to implement and deliver

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

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

  22. Yoga program fidelity

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

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

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Rogers LQ, Courneya KS, Verhulst S, Markwell S, Lanzotti V, Shah P. Exercise barrier and task self-efficacy in breast cancer patients during treatment. Support Care Cancer. 2006 Jan;14(1):84-90. doi: 10.1007/s00520-005-0851-2. Epub 2005 Jul 9. PubMed 16007455 ↗
  • Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6. PubMed 4053261 ↗
  • Acaster S, Dickerhoof R, DeBusk K, Bernard K, Strauss W, Allen LF. Qualitative and quantitative validation of the FACIT-fatigue scale in iron deficiency anemia. Health Qual Life Outcomes. 2015 May 17;13:60. doi: 10.1186/s12955-015-0257-x. PubMed 25980742 ↗
  • 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.
  • Chang VT, Hwang SS, Feuerman M. Validation of the Edmonton Symptom Assessment Scale. Cancer. 2000 May 1;88(9):2164-71. doi: 10.1002/(sici)1097-0142(20000501)88:93.0.co;2-5. PubMed 10813730 ↗
  • Pickard AS, De Leon MC, Kohlmann T, Cella D, Rosenbloom S. Psychometric comparison of the standard EQ-5D to a 5 level version in cancer patients. Med Care. 2007 Mar;45(3):259-63. doi: 10.1097/01.mlr.0000254515.63841.81. PubMed 17304084 ↗
  • Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570. PubMed 8445433 ↗
  • Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822. PubMed 12703651 ↗
  • Neff KD. Development and validation of a scale to measure self-compassion. Self Ident, 2003. 2: 223-50.
  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. PubMed 6668417 ↗
  • Sani F, Madhok V, Norbury M, Dugard P, Wakefield JR. Greater number of group identifications is associated with lower odds of being depressed: evidence from a Scottish community sample. Soc Psychiatry Psychiatr Epidemiol. 2015 Sep;50(9):1389-97. doi: 10.1007/s00127-015-1076-4. Epub 2015 Jun 10. PubMed 26058588 ↗
  • McNeely ML, Sellar C, Williamson T, Shea-Budgell M, Joy AA, Lau HY, Easaw JC, Murtha AD, Vallance J, Courneya K, Mackey JR, Parliament M, Culos-Reed N. Community-based exercise for health promotion and secondary cancer prevention in Canada: protocol for a hybrid effectiveness-implementation study. BMJ Open. 2019 Sep 13;9(9):e029975. doi: 10.1136/bmjopen-2019-029975. PubMed 31519676 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05314803
Lead sponsor
University of Calgary
Collaborators
Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR)
Responsible party
Sponsor
First posted
Apr 6, 2022
Start date
Sep 1, 2021
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Apr 6, 2022

Study contacts

S. Nicole Culos-Reed, PhD
Contact
nculosre@ucalgary.ca
403-220-7540
Amanda Wurz, PhD
Contact
amanda.wurz@ufv.ca
604-504-7441 ext. 2846
S. Nicole Culos-Reed, PhD
study director · University of Calgary

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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