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

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 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.

Study Overview

• Status: Terminated
• Conditions: Ovarian Cancer
• Intervention / Treatment: 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
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Total study duration is anticipated to require approximately 24 weeks

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: November 30, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Estimate): November 6, 2013
• Last Update Submitted That Met QC Criteria: November 5, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Yoga; Women; Ovarian Cancer; Lifestyle
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms
• Other Study ID Numbers: NU12G05