THE EFFECTS OF YOGA ON QUALITY OF LIFE AMONG A POPULATION OF OVARIAN/ FALLOPIAN TUBE/ PRIMARY PERITONEAL CANCER PATIENTS RECEIVING CHEMOTHERAPY: A FEASIBILITY STUDY
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Northwestern University
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
No Intervention; Arm A; Control Group
24 subjects who declined yoga but agreed to data collection
Active Comparator; Arm B; Intervention Group
24 subjects participating in 8 weeks of Yoga and agreed to data collection
Intervention: Yoga (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Nikki Neubauer
Assistant Professor in Obstetrics and Gynecology
Northwestern University