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

This study has been terminated.
(The investigators concluded that it is not feasible due to the lack of participation and difficulty in recruiting patients.)
Sponsor:
Information provided by (Responsible Party):
Nikki Neubauer, Northwestern University
ClinicalTrials.gov Identifier:
NCT01743547
First received: November 30, 2012
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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 Intervention
Ovarian Cancer
Other: Yoga

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: THE EFFECTS OF YOGA ON QUALITY OF LIFE AMONG A POPULATION OF OVARIAN/ FALLOPIAN TUBE/ PRIMARY PERITONEAL CANCER PATIENTS RECEIVING CHEMOTHERAPY: A FEASIBILITY STUDY

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 25
Study Start Date: November 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01743547

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

No publications provided

Responsible Party: Nikki Neubauer, Assistant Professor in Obstetrics and Gynecology, Northwestern University
ClinicalTrials.gov Identifier: NCT01743547     History of Changes
Other Study ID Numbers: NU12G05
Study First Received: November 30, 2012
Last Updated: November 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Women
Yoga
Ovarian Cancer
Lifestyle

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

ClinicalTrials.gov processed this record on July 28, 2014