Yoga for Young Adults Affected by Cancer

Young Adult Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05314803
• Other study ID #: HREBA.CC-20-0098 (sub-study)
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 1, 2028

Study information

• Verified date: February 2022
• Source: University of Calgary
• Contact: S. Nicole Culos-Reed, PhD
• Phone: 403-220-7540
• Email: nculosre[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This single-group, mixed-methods project will explore effectiveness and implementation of the yoga program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Young Adult Cancer

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

Chang VT, Hwang SS, Feuerman M. Validation of the Edmonton Symptom Assessment Scale. Cancer. 2000 May 1;88(9):2164-71. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. Epub 2005 Jul 9. — View Citation

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. — View Citation

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.

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach	The number of people who participate, and reasons why or why not.	Through study completion, an average of 5 years
Secondary	Attendance	Number of classes attended out of the number of classes offered by study staff.	Through study completion, an average of 5 years
Secondary	Adherence	Number of classes attended out of the number of classes offered by study staff.	Through study completion, an average of 5 years
Secondary	Missing data	Percentage of missing data on quantitative measures and completion of qualitative interviews.	Through study completion, an average of 5 years
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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