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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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ovarian Cancer |
Other: Yoga |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Other: Yoga
Patients will be randomized to Yoga or control group. Those in Yoga intervention will receive 8 weekly yoga sessions.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | 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
Contacts and Locations| United States, Illinois | |
| Northwestern Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Nikki Neubauer, MD 312-472-4684 | |
| Contact: Cary Passaglia, CCRP 312-472-5725 c-passaglia@northwestern.edu | |
| Principal Investigator: Nikki Neubauer, MD | |
More Information
No publications provided
| Responsible Party: | Nikki Neubauer, Assistant Professor in Obstetrics and Gynecology, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01743547 History of Changes |
| Other Study ID Numbers: | NU12G05 |
| Study First Received: | November 30, 2012 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
Women Yoga Ovarian Cancer Lifestyle |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on May 21, 2013