MedDataX Logo

The Effects Of Yoga On Quality Of Life Among A Population Of Ovarian/ Fallopian Tube/ Primary Peritoneal Cancer Patients Receiving Chemotherapy: A Feasibility Study

NCT ID: NCT01743547

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Women Yoga Ovarian Cancer Lifestyle

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No Intervention; Arm A; Control Group

24 subjects who declined yoga but agreed to data collection

Group Type NO_INTERVENTION

No interventions assigned to this group

Active Comparator; Arm B; Intervention Group

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

Group Type ACTIVE_COMPARATOR

Yoga

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Yoga

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nikki Neubauer

Assistant Professor in Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NU12G05

Identifier Type: -

Identifier Source: org_study_id