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Yoga for Adolescent and Young Adult Non-Curative Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01901237
First Posted: July 17, 2013
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Dalhousie University
IWK Health Centre
Nova Scotia Health Authority
Information provided by (Responsible Party):
Rob Rutledge, Nova Scotia Health Authority
  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: None (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

Further study details as provided by Rob Rutledge, Nova Scotia Health Authority:

Primary Outcome Measures:
  • Feasibility: Recruitment [ Time Frame: Final: end of week 7 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Enrollment: 5
Study Start Date: September 2013
Study Completion Date: June 13, 2017
Primary Completion Date: June 13, 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901237


Locations
Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 4R2
Sponsors and Collaborators
Rob Rutledge
Dalhousie University
IWK Health Centre
Nova Scotia Health Authority
Investigators
Principal Investigator: Rob Rutledge, MD, FRCPC Capital District Health Authority, Halifax, Canada
  More Information

Additional Information:
Published abstract.  This link exits the ClinicalTrials.gov site

Responsible Party: Rob Rutledge, Associate Professor, Department of Medicine, Dalhousie University, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01901237     History of Changes
Other Study ID Numbers: CDHA-RS/2014-067
First Submitted: July 11, 2013
First Posted: July 17, 2013
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by Rob Rutledge, Nova Scotia Health Authority:
Cancer
Adolescent and Young Adult
Exercise
Physical Activity
Quality of Life
End-of-Life
 Palliative
Terminal
Yoga
Alternative Therapies
Fitness
Fatigue


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