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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01743547
• Other study ID #: NU12G05
• Status: Terminated
• Phase: N/A
• First received: November 30, 2012
• Last updated: November 5, 2013
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• Yoga
Patients will be randomized to Yoga or control group. Those in Yoga intervention will receive 8 weekly yoga sessions.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No