Back to resultsGuided Imagery in the Perioperative Period in Gynecologic Oncology Patients
Primary Purpose
Uterine Cervical Neoplasms, Uterine Neoplasms, Ovarian Neoplasms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Imagery With Audio Media
Sponsored by
About this trial
This is an interventional supportive care trial for Uterine Cervical Neoplasms focused on measuring gynecologic cancer, guided imagery, postoperative distress, perioperative distress
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.
Sites / Locations
- University of Michigan Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Guided Imagery
Routine Postoperative Care
Arm Description
Guided Imagery With Audio Media
Subjects will receive routine pre-operative, intra-operative, post-operative, chemotherapy, and radiation care as dictated by pathologic diagnosis.
Outcomes
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.
Level of distress in the delayed postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.
Secondary Outcome Measures
Level of distress, measured by questionnaire using the Hospital Anxiety and Depression Scale-total (HADS-T).
Level of anxiety and depressions, measured by questionnaire using the Hospital Anxiety and Depression Scale subscale for anxiety (HADS-A) and depression (HADS-D).
Level of pain, measured by a 7-item questionnaire using a Likert numerical rating scale for pain
Perioperative analgesic use, measured by patient-completed usage log and hospital medical record.
Patient satisfaction regarding in hospital perioperative care, measured by a questionnaire adapted from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.
Effect of perioperative guided imagery on health care compliance, measured by the General Adherence Scale (GAS) survey.
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.
The effect of perioperative guided imagery on hope, measured by the Adult Hope Scale (AHS) questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02444195
Brief Title
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
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 1, 2016 (Actual)
Study Completion Date
May 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms, Uterine Neoplasms, Ovarian Neoplasms, Urogenital Neoplasms, Fallopian Tube Neoplasms
Keywords
gynecologic cancer, guided imagery, postoperative distress, perioperative distress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Guided Imagery
Arm Type
Experimental
Arm Description
Guided Imagery With Audio Media
Arm Title
Routine Postoperative Care
Arm Type
No Intervention
Arm Description
Subjects will receive routine pre-operative, intra-operative, post-operative, chemotherapy, and radiation care as dictated by pathologic diagnosis.
Intervention Type
Behavioral
Intervention Name(s)
Guided Imagery With Audio Media
Intervention Description
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.
Primary Outcome Measure Information:
Title
Level of distress in the immediate postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.
Time Frame
postoperative day 1
Title
Level of distress in the delayed postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.
Time Frame
6-8 week postoperative exam
Secondary Outcome Measure Information:
Title
Level of distress, measured by questionnaire using the Hospital Anxiety and Depression Scale-total (HADS-T).
Time Frame
postoperative day 1 and 6-8 week postoperative exam
Title
Level of anxiety and depressions, measured by questionnaire using the Hospital Anxiety and Depression Scale subscale for anxiety (HADS-A) and depression (HADS-D).
Time Frame
postoperative day 1 and 6-8 week postoperative exam
Title
Level of pain, measured by a 7-item questionnaire using a Likert numerical rating scale for pain
Time Frame
postoperative day 1 and 6-8 week postoperative exam
Title
Perioperative analgesic use, measured by patient-completed usage log and hospital medical record.
Time Frame
postoperative day 1 and 6-8 week postoperative exam
Title
Patient satisfaction regarding in hospital perioperative care, measured by a questionnaire adapted from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.
Time Frame
postoperative day 1 and 6-8 week postoperative exam
Title
Effect of perioperative guided imagery on health care compliance, measured by the General Adherence Scale (GAS) survey.
Time Frame
6-8 week postoperative visit
Title
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.
Time Frame
postoperative day 1 and 6-8 week postoperative exam
Title
The effect of perioperative guided imagery on hope, measured by the Adult Hope Scale (AHS) questionnaire.
Time Frame
postoperative day 1 and 6-8 week postoperative exam
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandy Michaels, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Rebecca Liu, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients
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