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 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|
- 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.
|Study Start Date:||November 2012|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
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
Patients will be randomized to Yoga or control group. Those in Yoga intervention will receive 8 weekly yoga sessions.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743547
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|