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The Effects Of Yoga On Quality Of Life Among A Population Of Ovarian/ Fallopian Tube/ Primary Peritoneal Cancer Patients Receiving Chemotherapy: A Feasibility Study

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ClinicalTrials.gov Identifier: NCT01743547
Recruitment Status : Terminated (The investigators concluded that it is not feasible due to the lack of participation and difficulty in recruiting patients.)
First Posted : December 6, 2012
Last Update Posted : November 6, 2013
Information provided by (Responsible Party):
Nikki Neubauer, Northwestern University

Brief Summary:
This is a pilot study to establish the feasibility of an eight-week yoga intervention and to estimate the effect size on QoL in female patients with ovarian, fallopian tube and primary peritoneal malignancies receiving chemotherapy for the treatment of primary or recurrent cancer.

Condition or disease Intervention/treatment
Ovarian Cancer Other: Yoga

Detailed Description:
The primary objective of this study was to determine the feasibility of implementing a yoga program among gynecologic cancer patients receiving chemotherapy. The investigators concluded that it is not feasible due to the lack of participation and difficulty in recruiting patients. Of 25 consented patients, 16 agreed to participate in the control arm, 9 agreed to participate in the Yoga classes. Three (3) of those 9 changed their minds and withdrew consent. Of the 6 remaining patients, only 3 attended at least 1 of the 8 classes.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : November 2012
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: No Intervention; Arm A; Control Group
24 subjects who declined yoga but agreed to data collection
Active Comparator: Active Comparator; Arm B; Intervention Group
24 subjects participating in 8 weeks of Yoga and agreed to data collection
Other: Yoga
Patients will be randomized to Yoga or control group. Those in Yoga intervention will receive 8 weekly yoga sessions.

Primary Outcome Measures :
  1. All patients included in the study will be assessed for response to treatment; the primary outcome is change in QoL domains after yoga class intervention. Planned subgroup analysis: stratification by participation category [ Time Frame: Total study duration is anticipated to require approximately 24 weeks ]

    Pilot study to establish the feasibility of a yoga program & estimate the effect size of a yoga intervention on QoL in patients with epithelial ovarian, fallopian tube & primary peritoneal cancer receiving chemotherapy for the treatment.The goal for each individual question on the questionnaire is to have a 90-95% completion rate. The validated instruments: FACT-O, FACIT-F, FACIT-Sp, CES-D, PROMIS, and PSQI will be scored according to their respective guidelines, and then paired t-tests will be used to compare the pre-yoga and post-yoga means.

    Participant completion will be recorded in one of three ways: complete, meaning the participant attended 5 or more yoga sessions and filled out all the required surveys; partially complete, meaning the participant attended 1-4 sessions, and/or did not fill out all the required surveys; and did not participate, meaning the participant attended 0 sessions. All analyses will be stratified for participation category.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed diagnosis of epithelial ovarian/fallopian tube/primary peritoneal cancer
  • Participant must be age 18 or older
  • Participants must be 6 weeks post-surgery
  • Participant must be currently receiving chemotherapy or beginning a regimen within the next four weeks
  • Participant must be willing to attend the intervention sessions
  • All subjects must have given signed, informed consent prior to registration in the study.

Exclusion Criteria:

  • Participant has practiced yoga more than 4 times in the last year
  • Participant has a surgical procedure scheduled during the 8 weeks that they would be part of the intervention
  • Participant has an ECOG performance status less than or equal to two

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743547

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University

Responsible Party: Nikki Neubauer, Assistant Professor in Obstetrics and Gynecology, Northwestern University
ClinicalTrials.gov Identifier: NCT01743547     History of Changes
Other Study ID Numbers: NU12G05
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013

Keywords provided by Nikki Neubauer, Northwestern University:
Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders