NCT01743547

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable ovarian-cancer

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 6, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

November 30, 2012

Last Update Submit

November 5, 2013

Conditions

Ovarian Cancer

Keywords

WomenYogaOvarian CancerLifestyle

Outcome Measures

Primary Outcomes (1)

  • 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.

    Total study duration is anticipated to require approximately 24 weeks

Study Arms (2)

No Intervention; Arm A; Control Group

NO INTERVENTION

24 subjects who declined yoga but agreed to data collection

Active Comparator; Arm B; Intervention Group

ACTIVE COMPARATOR

24 subjects participating in 8 weeks of Yoga and agreed to data collection

Other: Yoga

Interventions

YogaOTHER

Patients will be randomized to Yoga or control group. Those in Yoga intervention will receive 8 weekly yoga sessions.

Active Comparator; Arm B; Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Yoga

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Obstetrics and Gynecology

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 6, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 6, 2013

Record last verified: 2013-11

Locations

US(1)