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EHealth Mindful Movement and Breathing in Improving Outcomes in Participants Undergoing Gynecologic Surgery

NCT ID: NCT03379376

Last Updated: 2019-12-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-05

Study Completion Date

2018-11-02

Brief Summary

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This trial determines how well eHealth mindful movement and breathing works to improve outcomes in participants undergoing gynecologic surgery. Supportive therapy, such as eHealth mindful movement and breathing, uses techniques that include gentle movements, breathing, and relaxation techniques which may help participants cope with and improve their surgical experiences.

Detailed Description

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PRIMARY OBJECTIVES:

I. To field-test implementation strategies of the mindful movement and breathing (eMMB) intervention that has been adapted to the eHealth Format.

OUTLINE:

Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible.

After completion of study, participants are followed up at 4 weeks from surgery.

Conditions

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Female Reproductive System Neoplasm Malignant Female Reproductive System Neoplasm Malignant Uterine Neoplasm Ovarian Carcinoma Ovarian Neoplasm Suspicious for Malignancy Uterine Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive Care (eMMB)

Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible.

Group Type EXPERIMENTAL

Questionnaire Administration

Intervention Type OTHER

Receive questionnaire

Supportive Care

Intervention Type PROCEDURE

Undergo eHealth mindful moving and breathing

Interventions

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Questionnaire Administration

Receive questionnaire

Intervention Type OTHER

Supportive Care

Undergo eHealth mindful moving and breathing

Intervention Type PROCEDURE

Other Intervention Names

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Supportive Therapy Symptom Management Therapy, Supportive

Eligibility Criteria

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Inclusion Criteria

* Scheduled for an abdominal gynecological surgery (i.e. uterine, ovarian) to remove a mass that is suspected to be malignant
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
* Cognitively able to complete assessments as judged by the study team
* Able to understand, read and write English

Exclusion Criteria

* Have schizophrenia or any other psychotic disorder
* Have a diagnosed sleep disorder including untreated obstructive sleep apnea, periodic limb movement disorder, or restless leg syndrome
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie Sohl

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NCI-2018-00584

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 04517

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00046462

Identifier Type: -

Identifier Source: org_study_id