Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients

NCT02444195 | Completed

• 1 other identifier: HUM00095520
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

gynecologic cancer; guided imagery; postoperative distress; perioperative distress

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

Study Arms (2)

Guided Imagery

EXPERIMENTAL

Guided Imagery With Audio Media

Behavioral: Guided Imagery With Audio Media

Routine Postoperative Care

NO INTERVENTION

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

Interventions

Guided Imagery With Audio Media 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.

Guided Imagery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

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

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Male Urogenital Diseases; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Brandy Michaels, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• J. Rebecca Liu, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologic Oncology Fellow

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 14, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 20, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)