Fallopian Tube Neoplasms, Ovarian Neoplasms, Urogenital Neoplasms, Uterine Cervical Neoplasms, Uterine Neoplasms
Conditions
Keywords
gynecologic cancer, guided imagery, postoperative distress, perioperative distress
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.
Interventions
BEHAVIORALGuided 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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Effect of perioperative guided imagery on health care compliance, measured by the General Adherence Scale (GAS) survey. | 6-8 week postoperative visit |
| 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 |
Countries
United States
Outcome results
None listed