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:
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: September 9, 2013
Last verified: September 2013
  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 2013
Estimated Primary Completion Date: November 2013 (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 29 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 15-29 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

Contacts
Contact: Hillary Woodside, MSc (candidate) (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 (candidate)    (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: September 9, 2013
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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014