Yoga Intervention for Cancer Survivors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Debra Friedman, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01228955
First received: October 15, 2010
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition
Cancer Survivors
Yoga

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Yoga Intervention for Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The investigators will be opening up an hourly yoga class for 10 weeks to all cancer survivors at VICC and at Nashville General Hospital


Secondary Outcome Measures:
  • Levels of Fatigue using the SF-36 and Psychological Distress using BSI-18 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Participants in the Yoga Study will be asked to complete the SF-36 and BSI-18 at three different time points in the study. Prior to start of a yoga class, at the end of the 10 week yoga class and 3 months after the completion of the yoga class.


Enrollment: 48
Study Start Date: February 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Yoga Group
Group will enter a 10 week yoga class

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Survivors of Adult or Pediatric Cancer

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  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: NCT01228955

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Debra L Friedman, MD, MS Vanderbilt University
  More Information

No publications provided

Responsible Party: Debra Friedman, Division Director, Pediatric Hematology/Oncology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01228955     History of Changes
Other Study ID Numbers: 091309
Study First Received: October 15, 2010
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014