Clinical trial NCT05072639: Preoperative Guided Imagery in Patients Undergoing Urologic Surgery
Official title: Preoperative Guided Imagery in Patients Undergoing Urologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urologic Cancer
Keywords: Meditation
Guided Imagery
Urologic-oncology Surgery
Anxiety reduction
Radical cystectomy
Radical nephrectomy
Partial nephrectomy
Radical prostatectomy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective randomized controlled trial of patients undergoing major urologic-oncologic surgery at the University of California, San Francisco (UCSF) Medical Center and the Helen Diller Family Comprehensive Cancer Center. This clinical trial examines the effect of guided meditation before surgery on the levels of anxiety, stress, sleep disturbance, and quality of life among patients scheduled to undergo a major urologic surgery for cancer. A cancer diagnosis and the treatments associated with it can be very stressful for patients, leading to depression, sleep disturbances, and lower quality of life. Mind-body practices such as guided meditation have been used for thousands of years to reduce the effects of chronic stress and to improve quality of life. This clinical trial examines the effects of guided meditation on the stress, depression, and quality of life levels of patients undergoing urologic surgery for their cancer.

Detailed description: PRIMARY OBJECTIVE:

I. To determine the effect of 14 days of preoperative guided visualization meditation on patients' anxiety undergoing major urologic-oncology surgery.

SECONDARY OBJECTIVES:

I. To determine the effect of preoperative guided visualization meditation on patients' depression, stress, and quality of life.

II. To examine the difference in Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey question scores between the two study groups.

III. To determine the ability of patient to perform a daily 23 minute meditation.

IV. To examine the correlation between depression and emergency department (ED) visits and readmissions post-operations.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients listen to guided meditation over 23 minutes daily for two weeks before their standard of care surgery. Patients also complete surveys over 10-15 minutes at baseline, after 10 days, 1 day before standard of care surgery, the day after discharge, and then 4 weeks after surgery.

ARM 2: Patients complete surveys over 10-15 minutes at baseline, after 10 days, 1 day before standard of care surgery, the day after discharge, and then 4 weeks after surgery.

Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 18 years of age.
* Patients undergoing radical cystectomy, radical or partial nephrectomy, or radical prostatectomy at the University of California, San Francisco (UCSF) Medical Center and the Helen Diller Family Comprehensive Cancer Center
* Access to an electronic device that can play mp3 recording and for survey completion
* At least a 2 week window from date of surgical booking to the scheduled surgery

Exclusion Criteria:

* Inability to consent for the study (ie, they have a surrogate decision maker).
* Non-English speaker (the meditations are only available in English)
* Patients scheduled for surgery less than 2 weeks away

Primary outcomes:
measure: Change in scores on the State-Trait Anxiety Inventory (STAI) from baseline to day before surgery
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Change in scores on the State-Trait Anxiety Inventory (STAI) over time
timeFrame: Up to 6 months
measure: Change in scores on the Center for Epidemiologic Depression Scale (CESD) over time
timeFrame: Up to 6 months
measure: Change in scores on the Perceived Stress Scale (PSS) over time
timeFrame: Up to 6 months
measure: Change in scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer over time
timeFrame: Up to 6 months
measure: Change in scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) for cancer patients (EORTC-QLQ-C30) - Functional Domains over time
timeFrame: Up to 6 months
measure: Change in scores on the EORTC-QLQ-C30 Global Health Status over time
timeFrame: Up to 6 months
measure: Change in scores on the EORTC-QLQ-C30 - Symptoms over time
timeFrame: Up to 6 months
measure: Mean scores on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey
timeFrame: Up to 6 months
measure: Proportion of participants who completed daily meditation
timeFrame: Up to 6 months
measure: Percentage of emergency department (ED) visits at 4 weeks post-operative
timeFrame: 4 weeks
measure: Rates of hospital re-admission rates at 4 weeks post operatively
timeFrame: 4 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sima Porten, MD,
role: PRINCIPAL_INVESTIGATOR
References: