Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-05-01

Brief Summary

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The purpose of this study is to evaluate the effectiveness of self-administered perioperative guided imagery to reduce perioperative distress in gynecologic oncology patients undergoing surgical management for a presumed cancer diagnosis.

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Detailed Description

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Conditions

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Uterine Cervical Neoplasms Uterine Neoplasms Ovarian Neoplasms Urogenital Neoplasms Fallopian Tube Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Guided Imagery

Guided Imagery With Audio Media

Group Type EXPERIMENTAL

Guided Imagery With Audio Media

Intervention Type BEHAVIORAL

Subjects assigned to the experimental arm will be asked to participate in meditation daily using the audio media provided for the 7 days prior to surgery, in the preoperative holding area, for the 7 days following surgery, and are encouraged to engage in affirmations module use at least weekly in the 6-8 week postoperative period.

Routine Postoperative Care

Subjects will receive routine pre-operative, intra-operative, post-operative, chemotherapy, and radiation care as dictated by pathologic diagnosis.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Guided Imagery With Audio Media

Subjects assigned to the experimental arm will be asked to participate in meditation daily using the audio media provided for the 7 days prior to surgery, in the preoperative holding area, for the 7 days following surgery, and are encouraged to engage in affirmations module use at least weekly in the 6-8 week postoperative period.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Undergoing surgical management for a suspected diagnosis of Gynecologic Malignancy (Endometrial, Ovarian, Vulvar, Vaginal, Primary Peritoneal, Fallopian Tube)
* Age 18 or greater
* Receiving care at University of Michigan Comprehensive Cancer Center Gynecologic Oncology Clinic or at St. Joseph Mercy Hospital, Alexander Cancer Care Center
* Able to understand and read English
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Patients must have working telephone, mobile or land line

Exclusion Criteria

* Severe hearing impairment that limits the ability to use audio-based guided imagery modules
* Current documented alcohol abuse or illicit drug substance abuse
* Planned outpatient surgery
* Patients currently participating in a meditation practice for more than 1 hour per week prior to preoperative visit.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No