Yoga for Adolescent and Young Adult Non-Curative Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2016 by Nova Scotia Health Authority

Sponsor:

Collaborators:

Dalhousie University

IWK Health Centre

Nova Scotia Health Authority

Information provided by (Responsible Party):

Rob Rutledge, Nova Scotia Health Authority

ClinicalTrials.gov Identifier:

NCT01901237

First received: July 11, 2013

Last updated: January 28, 2016

Last verified: January 2016

History of Changes

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

Further study details as provided by 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.


Estimated Enrollment:	10
Study Start Date:	September 2013
Estimated Study Completion Date:	June 2016
Estimated Primary Completion Date:	June 2016 (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.

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 (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

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	(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

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


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
Study First Received:	July 11, 2013
Last Updated:	January 28, 2016

Keywords provided by Nova Scotia Health Authority:


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 May 25, 2017

To Top