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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01901237
Other study ID # CDHA-RS/2014-067
Secondary ID
Status Completed
Phase N/A
First received July 11, 2013
Last updated July 11, 2017
Start date September 2013
Est. completion date June 13, 2017

Study information

Verified date July 2017
Source Nova Scotia Health Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Adolescents and young adults who are living with cancer are not benefiting from the same age-appropriate physical and psychosocial care, as are children and older adults. As a result, their unique needs often go unmet or unaddressed. Studies have demonstrated that a lack of age-appropriate care may be responsible for a deceased quality of life. Studies have also shown that physical activity is able to reduce many of the negative side-effects linked to cancer and its treatment (e.g., nausea, vomiting, fatigue). A light form of physical activity that is both safe and manageable for cancer patients is yoga. The purpose of this study is to examine the achievability and safety of a light 7-week home/hospice-based Hatha yoga program (available on DVD) in the adolescent and young adult non-curative cancer population. This study will also examine the ability of yoga to reduce cancer related side effects.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date June 13, 2017
Est. primary completion date June 13, 2017
Accepts healthy volunteers No
Gender All
Age group 15 Years to 39 Years
Eligibility Inclusion Criteria:

- Diagnosed with a non-curative cancer and assigned to non-curative or palliative care

- Between 15-39 years of age

- Have primary physician/oncologist consent to participate

Exclusion Criteria:

- Experience any medical conditions that contraindicate yoga (e.g., bone metastases)

- Exhibit cognitive limitations (e.g., psychiatric disorders)

- Score below 30% on Palliative Performance Status Scale

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Hatha Yoga
This is a 7-week home/hospice-based instructive Hatha yoga program (available on DVD) for adolescent and young adults diagnosed with a non-curative cancer. Participants will be asked to complete a minimum of one, 75-minute yoga session per week. The DVD package includes four discs that increase in difficulty over the course of the 7-week program. The DVD focuses on postures and breathing exercises. Participants will be asked to keep track of the number and duration of yoga sessions completed over the 7-week period.

Locations

Country Name City State
Canada Dalhousie University Halifax Nova Scotia

Sponsors (4)

Lead Sponsor Collaborator
Rob Rutledge Dalhousie University, IWK Health Centre, Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility: Recruitment Recruitment will be calculated by the number of patients who consent to participate, divided by the number of eligible participants recommended by the primary oncologist/physician. Final: end of week 7
Primary Feasibility: Retention Retention: Will be determined by reporting the number of participants who complete the baseline and post-program questionnaire and follow-up testing. Final: end of week 7
Primary Feasibility: Adherence Adherence: Participants will be asked to record the number of yoga sessions performed each week. Overall adherence will be calculated by summing the actual number of sessions the participant engaged in, divided by the recommended number of sessions. Final: end of week 7
Primary Safety Safety: Any adverse events reported by the participant will be recorded. Final: end of week 7
Secondary Changes in Quality of Life Participants will be asked to complete the Functional Assessment of Chronic Illness Therapy - Palliative Care subscale (FACIT-Pal) and the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being subscale (FACIT-Sp) at baseline and post-intervention. Baseline: week 1; Final: week 7
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