Yoga for Young Adults Affected by Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Young Adult Cancer; Young Adult Oncology
• Intervention / Treatment: Behavioral: Yoga

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amanda Wurz, PhD; Phone Number: 2846 604-504-7441; Email: amanda.wurz@ufv.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • Recruiting
      • University of Calgary
      • Contact: Wellness Lab; Phone Number: 403-210-8482; Email: wellnesslab@ucalgary.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach	The number of people who participate, and reasons why or why not.	Through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance	Number of classes attended out of the number of classes offered by study staff.	Through study completion, an average of 5 years
Adherence	Number of classes attended out of the number of classes offered by study staff.	Through study completion, an average of 5 years
Missing data	Percentage of missing data on quantitative measures and completion of qualitative interviews.	Through study completion, an average of 5 years
Barriers and facilitators to exercise participation	Change in Barrier Self-Efficacy Scale (1). Scale range 0-100; higher scores indicates less barriers to participation.	Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
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.	Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
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.	Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
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.	Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
Cancer-related symptoms	Change in Edmonton Symptom Assessment Scale (5). Scale range 0-10; lower scores indicate fewer/less severe symptoms.	Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
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.	Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
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.	Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
Mindfulness	Change in Mindful Attention Awareness Scale (8). Scale range 1-6; higher scores indicate higher levels of dispositional mindfulness.	Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
Self-compassion	Change in Self-Compassion Scale (9). Scale range 1-5; higher scores indicate greater self-compassion.	Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
Stress	Change in Perceived Stress Scale (10). Scale range 0-4; some items are reverse scored; higher scores indicate more perceived stress.	Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
Group identification	Change in Group Identification Scale (11). Scale range 1-7; higher scores indicate greater identification with the group.	Post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
Balance	Change in one legged stance test (seconds) (see 12).	Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
Shoulder range of motion	Change in active shoulder flexion range of motion (degrees) (see 12).	Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
Lower extremity flexibility	Change in sit-and-reach test (cm) (see 12).	Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
Functional performance	Change in sit-to-stand (number of repetitions in 30 seconds) (see 12).	Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
Aerobic endurance	Change in 2 minute step test (steps) results (see 12).	Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)
Adverse events	Adverse events will be defined as any negative effect caused (or suspected to be caused by) the yoga program.	Through study completion, an average of 5 years
Time to implement and deliver	Time and expertise to deliver the intervention and physical assessments will be tracked.	Through study completion, an average of 5 years
Yoga program fidelity	Fidelity of the physical activity program implementation will be assessed via randomly video-auditing a subset of classes.	Through study completion, an average of 5 years

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Canadian Institutes of Health Research (CIHR); Canadian Cancer Society (CCS)
• Investigators: Study Director: S. Nicole Culos-Reed, PhD, University of Calgary

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): December 31, 2027
• Study Completion (Anticipated): December 1, 2028

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HREBA.CC-20-0098 (sub-study)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No