NCT01901237

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

3.8 years

First QC Date

July 11, 2013

Last Update Submit

July 11, 2017

Conditions

Keywords

CancerAdolescent and Young AdultExercisePhysical ActivityQuality of LifeEnd-of-LifePalliativeTerminalYogaAlternative TherapiesFitnessFatigue

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • Safety

    Safety: Any adverse events reported by the participant will be recorded.

    Final: end of week 7

Secondary Outcomes (1)

  • Changes in Quality of Life

    Baseline: week 1; Final: week 7

Study Arms (1)

Hatha Yoga Program

OTHER

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

Interventions

Hatha YogaBEHAVIORAL

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.

Hatha Yoga Program

Eligibility Criteria

Age15 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, B3H 4R2, Canada

Location

Related Links

MeSH Terms

Conditions

NeoplasmsMotor ActivityDeathFatigue

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Rob Rutledge, MD, FRCPC

    Capital District Health Authority, Halifax, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Department of Medicine, Dalhousie University

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 17, 2013

Study Start

September 1, 2013

Primary Completion

June 13, 2017

Study Completion

June 13, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations