Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients

Study Overview
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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.

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

Conditions
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Uterine Cervical Neoplasms, Uterine Neoplasms, Ovarian Neoplasms, Urogenital Neoplasms, Fallopian Tube Neoplasms

Intervention / Treatment
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* Behavioral: Guided Imagery With Audio Media


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gynecologic cancer, guided imagery, postoperative distress, perioperative distress