Clinical trial NCT02444195: Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients
Official title: Self-Administered Guided Imagery in the Perioperative Period to Reduce Postoperative Distress in Gynecologic Oncology Patients: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Neoplasms
Uterine Neoplasms
Ovarian Neoplasms
Urogenital Neoplasms
Fallopian Tube Neoplasms
Keywords: gynecologic cancer
guided imagery
postoperative distress
perioperative distress
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Level of distress in the immediate postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.
timeFrame: postoperative day 1
measure: Level of distress in the delayed postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.
timeFrame: 6-8 week postoperative exam
Secondary outcomes:
measure: Level of distress, measured by questionnaire using the Hospital Anxiety and Depression Scale-total (HADS-T).
timeFrame: postoperative day 1 and 6-8 week postoperative exam
measure: Level of anxiety and depressions, measured by questionnaire using the Hospital Anxiety and Depression Scale subscale for anxiety (HADS-A) and depression (HADS-D).
timeFrame: postoperative day 1 and 6-8 week postoperative exam
measure: Level of pain, measured by a 7-item questionnaire using a Likert numerical rating scale for pain
timeFrame: postoperative day 1 and 6-8 week postoperative exam
measure: Perioperative analgesic use, measured by patient-completed usage log and hospital medical record.
timeFrame: postoperative day 1 and 6-8 week postoperative exam
measure: Patient satisfaction regarding in hospital perioperative care, measured by a questionnaire adapted from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.
timeFrame: postoperative day 1 and 6-8 week postoperative exam
measure: Effect of perioperative guided imagery on health care compliance, measured by the General Adherence Scale (GAS) survey.
timeFrame: 6-8 week postoperative visit
measure: 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.
timeFrame: postoperative day 1 and 6-8 week postoperative exam
measure: The effect of perioperative guided imagery on hope, measured by the Adult Hope Scale (AHS) questionnaire.
timeFrame: postoperative day 1 and 6-8 week postoperative exam
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Brandy Michaels, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: J. Rebecca Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: