Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT02444195

Collaborator

(none)

130

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Neoplasms Uterine Neoplasms Ovarian Neoplasms Urogenital Neoplasms Fallopian Tube Neoplasms	Behavioral: Guided Imagery With Audio Media	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Self-Administered Guided Imagery in the Perioperative Period to Reduce Postoperative Distress in Gynecologic Oncology Patients: A Randomized Control Trial

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Guided Imagery Guided Imagery With Audio Media	Behavioral: 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.
No Intervention: Routine Postoperative Care Subjects will receive routine pre-operative, intra-operative, post-operative, chemotherapy, and radiation care as dictated by pathologic diagnosis.

Arm

Intervention/Treatment

Experimental: Guided Imagery

Guided Imagery With Audio Media

Behavioral: 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.

No Intervention: Routine Postoperative Care

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

Outcome Measures

Primary Outcome Measures

Level of distress in the immediate postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument. [postoperative day 1]
Level of distress in the delayed postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument. [6-8 week postoperative exam]

Secondary Outcome Measures

Level of distress, measured by questionnaire using the Hospital Anxiety and Depression Scale-total (HADS-T). [postoperative day 1 and 6-8 week postoperative exam]
Level of anxiety and depressions, measured by questionnaire using the Hospital Anxiety and Depression Scale subscale for anxiety (HADS-A) and depression (HADS-D). [postoperative day 1 and 6-8 week postoperative exam]
Level of pain, measured by a 7-item questionnaire using a Likert numerical rating scale for pain [postoperative day 1 and 6-8 week postoperative exam]
Perioperative analgesic use, measured by patient-completed usage log and hospital medical record. [postoperative day 1 and 6-8 week postoperative exam]
Patient satisfaction regarding in hospital perioperative care, measured by a questionnaire adapted from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. [postoperative day 1 and 6-8 week postoperative exam]
Effect of perioperative guided imagery on health care compliance, measured by the General Adherence Scale (GAS) survey. [6-8 week postoperative visit]
Effect of perioperative guided imagery on health care related locus of control, measured by the Multidimensional Health Locus of Control-form A (MHLC-A) questionnaire. [postoperative day 1 and 6-8 week postoperative exam]
The effect of perioperative guided imagery on hope, measured by the Adult Hope Scale (AHS) questionnaire. [postoperative day 1 and 6-8 week postoperative exam]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.