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Young Adult CancerNCT05314803

Yoga for Young Adults Affected by Cancer

A study testing Yoga in people with Young Adult Cancer and Young Adult Oncology, run by University of Calgary at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Young Adult Cancer, Young Adult Oncology
What is being tested?
Yoga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteCanada
Study dates
1 Sep 2021to 1 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

S. Nicole Culos-Reed, PhD contact

403-220-7540

nculosre@ucalgary.ca

Amanda Wurz, PhD contact

604-504-7441 ext. 2846

amanda.wurz@ufv.ca

Canada1 site, 1 recruiting

  • University of Calgary

    Calgary, Alberta, T2N 1N4

    S. Nicole Culos-Reed, PhD, 403-220-7540, nculosre@ucalgary.ca

    Wellness Lab, 403-210-8482, wellnesslab@ucalgary.ca

    Recruiting

Other trials in Canada

About this study

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

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.

Being tested
Yoga

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YogaBehavioural

    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.

Study groups in NCT05314803
Study groupRoleWhat they receive
YogaExperimentalParticipants receive online, group-based yoga classes 2 times/week for 60 minutes/class over 12 weeks.
Receives: Behavioral: Yoga

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reach

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

    Measured: Through study completion, an average of 5 years

Secondary outcomes (22)

  1. Attendance

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

    Measured: Through study completion, an average of 5 years

  2. Adherence

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

    Measured: Through study completion, an average of 5 years

  3. Missing data

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: 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).

    Measured: 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).

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Through study completion, an average of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2022
  2. Study start1 Sep 2021
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05314803
Sponsor's protocol ID
HREBA.CC-20-0098 (sub-study)
Status last verified
Feb 2022
First submitted
29 Mar 2022
Last updated
6 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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

  • Wurz A, McLaughlin E, Janzen A, Cripps H, Huang L, Molina H, Cowley L, Dreger J, Culos-Reed SN, Quinn K, Currey IMOL, Pacelli MH, Coombs M, Shamshad S. A Protocol for a Mixed Methods, Single-Arm, Hybrid Effectiveness-Implementation Trial Evaluating a 12-week Yoga Intervention Delivered by Videoconference for Young Adults Diagnosed With Cancer. Glob Adv Integr Med Health. 2024 Dec 22;13:27536130241305130. doi: 10.1177/27536130241305130. eCollection 2024 Jan-Dec.

    PubMed 39717073

Questions about this trial

What is this clinical trial studying?

A study testing Yoga in people with Young Adult Cancer and Young Adult Oncology, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact S. Nicole Culos-Reed, PhD (403-220-7540, nculosre@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reach (time frame: Through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05314803, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.

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