Yoga for Adolescent and Young Adult Non-Curative Cancer Patients
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2013 by Capital District Health Authority, Canada
Sponsor:
Capital District Health Authority, Canada
Collaborators:
Dalhousie University
IWK Health Centre
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01901237
First received: July 11, 2013
Last updated: February 2, 2015
Last verified: September 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Advanced Cancer |
Behavioral: Hatha Yoga |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Impact of Yoga on Quality of Life for Adolescent and Young Adult Non-Curative Cancer Patients: A Pilot Study |
Resource links provided by NLM:
Further study details as provided by Capital District Health Authority, Canada:
Primary Outcome Measures:
- Feasibility: Recruitment [ Time Frame: Final: end of week 7 ] [ Designated as safety issue: No ]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.
- Feasibility: Retention [ Time Frame: Final: end of week 7 ] [ Designated as safety issue: No ]Retention: Will be determined by reporting the number of participants who complete the baseline and post-program questionnaire and follow-up testing.
- Feasibility: Adherence [ Time Frame: Final: end of week 7 ] [ Designated as safety issue: No ]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.
- Safety [ Time Frame: Final: end of week 7 ] [ Designated as safety issue: No ]Safety: Any adverse events reported by the participant will be recorded.
Secondary Outcome Measures:
- Changes in Quality of Life [ Time Frame: Baseline: week 1; Final: week 7 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Hatha Yoga Program
Single-arm pilot study of a 7-week home/hospice-based Hatha yoga program for adolescent and young adults with non-curative cancer.
|
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.
|
Eligibility| Ages Eligible for Study: | 15 Years to 39 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01901237
Please refer to this study by its ClinicalTrials.gov identifier: NCT01901237
Contacts
| Contact: Hillary Woodside, MSc | (902) 494-2579 | hillarywoodside@dal.ca | |
| Contact: Melanie Keats, PhD | (902) 494-7173 | melanie.keats@dal.ca |
Locations
| Canada, Nova Scotia | |
| Dalhousie University | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 4R2 | |
| Contact: Hillary Woodside, MSc (902) 494-2579 hillarywoodside@dal.ca | |
| Contact: Melanie Keats, PhD (902) 494-7173 melanie.keats@dal.ca | |
| Principal Investigator: Rob Rutledge, MD, FRCPC | |
Sponsors and Collaborators
Capital District Health Authority, Canada
Dalhousie University
IWK Health Centre
Investigators
| Principal Investigator: | Rob Rutledge, MD, FRCPC | Capital District Health Authority, Halifax, Canada |
More Information
No publications provided
| Responsible Party: | Capital District Health Authority, Canada |
| ClinicalTrials.gov Identifier: | NCT01901237 History of Changes |
| Other Study ID Numbers: | CDHA-RS/2014-067 |
| Study First Received: | July 11, 2013 |
| Last Updated: | February 2, 2015 |
| Health Authority: | Canada: Canadian Institutes of Health Research |
Keywords provided by Capital District Health Authority, Canada:
|
Adolescent and Young Adult Cancer Exercise Physical Activity Quality of Life End-of-Life |
Palliative Terminal Yoga Alternative Therapies Fitness Fatigue |
ClinicalTrials.gov processed this record on March 03, 2015