NCT05314803

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Sep 2021Dec 2028

Study Start

First participant enrolled

September 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 6, 2022

Status Verified

February 1, 2022

Enrollment Period

6.3 years

First QC Date

March 29, 2022

Last Update Submit

March 29, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reach

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

    Through study completion, an average of 5 years

Secondary Outcomes (22)

  • Attendance

    Through study completion, an average of 5 years

  • Adherence

    Through study completion, an average of 5 years

  • Missing data

    Through study completion, an average of 5 years

  • 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)

  • Physical activity levels

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

  • +17 more secondary outcomes

Study Arms (1)

Yoga

EXPERIMENTAL

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

Behavioral: Yoga

Interventions

YogaBEHAVIORAL

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.

Yoga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

Related Publications (13)

  • 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.

    PMID: 16007455BACKGROUND
  • 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.

    PMID: 4053261BACKGROUND
  • 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.

    PMID: 25980742BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 10813730BACKGROUND
  • 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.

    PMID: 17304084BACKGROUND
  • 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.

    PMID: 8445433BACKGROUND
  • 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.

    PMID: 12703651BACKGROUND
  • Neff KD. Development and validation of a scale to measure self-compassion. Self Ident, 2003. 2: 223-50.

    BACKGROUND
  • 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.

    PMID: 6668417BACKGROUND
  • 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.

    PMID: 26058588BACKGROUND
  • 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.

    PMID: 31519676BACKGROUND
  • 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.

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • S. Nicole Culos-Reed, PhD

    University of Calgary

    STUDY DIRECTOR

Central Study Contacts

S. Nicole Culos-Reed, PhD

CONTACT

Amanda Wurz, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 6, 2022

Study Start

September 1, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

April 6, 2022

Record last verified: 2022-02

Locations