NCT01228955

Brief Summary

Impaired health related quality of life (HRQOL) including fatigue, problems with sleep and psychosocial well being (physical, emotional, and spiritual) have been noted in adult cancer survivors. Physical domain is one of the most common measured indicators of HRQOL. Despite the tremendous implications of having an impaired QOL, few studies have staged interventions aimed at improving HRQOL in a heterogeneous group of cancer survivors. There is little literature examining whether a yoga intervention is feasible in a heterogeneous group of cancer survivors. The proposed research will utilize Vanderbilt Ingram Cancer Center (VICC), Nashville General Hospital (NGH) and REACH for Survivorship program for a pilot study. The investigators will see if a study using a broad range of diagnoses is feasible for a Yoga Intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2010

Typical duration for all trials

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

Study Start

First participant enrolled

February 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 27, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

2.1 years

First QC Date

October 15, 2010

Last Update Submit

April 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Cancer Survivors interested and willing to participate in a 10 week yoga class at Vanderbilt Ingram Cancer Center (VICC) and at Nashville General Hospital

    The investigators will be opening up an hourly yoga class for 10 weeks to all cancer survivors at VICC and at Nashville General Hospital

    12 months

Secondary Outcomes (1)

  • Levels of Fatigue using the SF-36 and Psychological Distress using BSI-18

    12 months

Study Arms (1)

Yoga Group

Group will enter a 10 week yoga class

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Survivors of Adult or Pediatric Cancer

You may qualify if:

  • Survivor population
  • Adults (18 years of age or above)
  • Patients treated for any cancers between the ages of 18 and 65 years of age
  • Received and concluded cancer treatment anytime from January 1, 2000 up to 1 month before start date of study
  • Received cancer treatment and care at either Vanderbilt-Ingram Cancer Center (VICC) or Nashville General Hospital (NGH) or are currently receiving cancer survivorship care at the Vanderbilt REACH for Survivorship Clinic
  • Obtain \*medical clearance to perform light exercise from primary care physician, oncologist or health care provider at REACH for Survivorship clinic (medical clearance needs to be obtained at least 2 weeks prior to starting yoga class).
  • Have completed, if ever received, any chemotherapy treatment from January 1, 2000 up to 1 month before start date of study
  • Patients with lymphedema due to cancer surgery/treatment are eligible
  • Alive without evidence of recurrent disease
  • Without evidence of a subsequent malignancy following initial cancer diagnosis
  • Provide informed consent
  • Should be able to sit on chair/floor and recline without assistance
  • Can read and understand English
  • Can have past experience with yoga or meditation

You may not qualify if:

  • Enrolled or attending a yoga class at time of recruitment
  • Currently receiving active treatment for cancer
  • Currently not in remission
  • Have any additional health concerns such as brain metastases or ventricular-peritoneal shunts at time of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Study Officials

  • Debra L Friedman, MD, MS

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Director, Pediatric Hematology/Oncology

Study Record Dates

First Submitted

October 15, 2010

First Posted

October 27, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 6, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations