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 study has been terminated.
(The investigators concluded that it is not feasible due to the lack of participation and difficulty in recruiting patients.)
Information provided by (Responsible Party):
Nikki Neubauer, Northwestern University
First received: November 30, 2012
Last updated: November 5, 2013
Last verified: November 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
||THE EFFECTS OF YOGA ON QUALITY OF LIFE AMONG A POPULATION OF OVARIAN/ FALLOPIAN TUBE/ PRIMARY PERITONEAL CANCER PATIENTS RECEIVING CHEMOTHERAPY: A FEASIBILITY STUDY
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 [ 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:
| Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743547
|Northwestern Memorial Hospital
|Chicago, Illinois, United States, 60611 |
No publications provided
||Nikki Neubauer, Assistant Professor in Obstetrics and Gynecology, Northwestern University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 30, 2012
||November 5, 2013
||United States: Institutional Review Board
Keywords provided by Northwestern University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 04, 2016
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Site