Back to resultsThe Effects Of Yoga On Quality Of Life Among A Population Of Ovarian/ Fallopian Tube/ Primary Peritoneal Cancer Patients Receiving Chemotherapy: A Feasibility Study
Primary Purpose
Ovarian Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
About this trial
This is an interventional supportive care trial for Ovarian Cancer focused on measuring Women, Yoga, Ovarian Cancer, Lifestyle
Eligibility 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
Sites / Locations
- Northwestern Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
No Intervention; Arm A; Control Group
Active Comparator; Arm B; Intervention Group
Arm Description
24 subjects who declined yoga but agreed to data collection
24 subjects participating in 8 weeks of Yoga and agreed to data collection
Outcomes
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
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 Outcome Measures
Full Information
NCT ID
NCT01743547
First Posted
November 30, 2012
Last Updated
November 5, 2013
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT01743547
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
The investigators concluded that it is not feasible due to the lack of participation and difficulty in recruiting patients.
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Women, Yoga, Ovarian Cancer, Lifestyle
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Intervention; Arm A; Control Group
Arm Type
No Intervention
Arm Description
24 subjects who declined yoga but agreed to data collection
Arm Title
Active Comparator; Arm B; Intervention Group
Arm Type
Active Comparator
Arm Description
24 subjects participating in 8 weeks of Yoga and agreed to data collection
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
Patients will be randomized to Yoga or control group. Those in Yoga intervention will receive 8 weekly yoga sessions.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Total study duration is anticipated to require approximately 24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects Of Yoga On Quality Of Life Among A Population Of Ovarian/ Fallopian Tube/ Primary Peritoneal Cancer Patients Receiving Chemotherapy: A Feasibility Study
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