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Yoga for Solid Tumor

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ClinicalTrials.gov Identifier: NCT03728205
Recruitment Status : Withdrawn (Covid-19)
First Posted : November 2, 2018
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE October 29, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date April 27, 2021
Actual Study Start Date  ICMJE December 15, 2018
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
The feasibility of implementing Eischens yoga interventions for solid tumor cancer patients undergoing radiation therapy. This will be measured by the success rate of recruitment and retention for 10 subjects. [ Time Frame: 12 months ]
Feasibility
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
  • Effects on fatigue [ Time Frame: 12 months ]
    Examine the effect of yoga on cancer and radiation related fatigue during radiation therapy. We will use the BFI results both before, during and after radiation therapy.
  • Effects on Stress Level [ Time Frame: 12 Months ]
    Examine the effect of yoga on cancer and radiation related fatigue during radiation therapy. We will use the NCCN Distress thermometer results both before, during and after radiation therapy.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 1, 2018)
Long Term [ Time Frame: 17 months ]
Examine the long term effect of yoga to be tested at the 6 months post radiation visit. We will use the BFI and distress thermometer to see if any positive results during yoga are sustained to the 6 month follow up visit.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Yoga for Solid Tumor
Official Title  ICMJE A Pilot Study On The Effect Of Yoga On Fatigue, And Stress Levels In Solid Tumor Cancer Patients Undergoing Active Radiation Therapy
Brief Summary The purpose of this study is to ascertain the effect of yoga interventions on radiation-related fatigue, and stress in cancer patients with stage I and II solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Solid Tumor, Adult
Intervention  ICMJE Behavioral: Yoga
Twice weekly yoga sessions for 12 weeks
Study Arms  ICMJE Experimental: Observational
All 10 pilot subjects will be taking yoga
Intervention: Behavioral: Yoga
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 12, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2018)
10
Actual Study Completion Date  ICMJE January 14, 2021
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Stage I and II Cancer patients with solid tumors undergoing RT for 4-8 weeks (external beam radiation).
  2. Patients of age >18, and all races will be included in the study.
  3. All patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Pennsylvania.
  4. Patients must be English speaking.
  5. Patients must be able to attend the schedule classes.

    Exclusion Criteria:

  6. Patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician orders.
  7. Patients with metastatic disease.
  8. Active smokers. Smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Self-reporting smokers that have been smoke free for 6 months may be included)
  9. Patients who currently practice or have recently practiced yoga (had not taken a yoga class on a regular bases in the last 6 months).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728205
Other Study ID Numbers  ICMJE UPCC 13918
831417 ( Other Identifier: Penn Medicine )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Abramson Cancer Center of the University of Pennsylvania
Study Sponsor  ICMJE Abramson Cancer Center of the University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Abramson Cancer Center of the University of Pennsylvania
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP