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Preoperative Guided Imagery in Patients Undergoing Urologic Surgery

Primary Purpose

Urologic Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Meditation
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urologic Cancer focused on measuring Meditation, Guided Imagery, Urologic-oncology Surgery, Anxiety reduction, Radical cystectomy, Radical nephrectomy, Partial nephrectomy, Radical prostatectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Meditation

Control group

Arm Description

Participants randomized to the meditation arm will receive an mp3 audio recording of the visual guided meditation will be sent an additional mp3 file specifically for the recovery phase of surgery. Participants will be asked to complete a series of pre-study questionnaires to determine their baseline anxiety, depression, stress, and quality of life scores. Subjects will then complete the same questionnaires at four additional time points: after 10 days of daily meditations, 1 day before their surgery, and day after discharge, and 4 weeks post-operation.

Participants received standard of care, including the option to attend a free "Prepare for Surgery workshop". Participants will be asked to complete a series of pre-study questionnaires to determine their baseline anxiety, depression, stress, and quality of life scores. Subjects will then complete the same questionnaires at four additional time points: after 10 days of daily meditations, 1 day before their surgery, and day after discharge, and 4 weeks post-operation.

Outcomes

Primary Outcome Measures

Change in scores on the State-Trait Anxiety Inventory (STAI) from baseline to day before surgery
The Spielberger et. al STAI is a commonly used measure of trait and state anxiety . It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It has 20 items for assessing trait anxiety and 20 for state anxiety for a total of 40 items. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "1=Almost Never" to 4="Almost Always") with a maximum score range of 40-160 when all 40 items are administered Higher scores indicate greater anxiety. A two sample t-test will be used to compare the change between anxiety scores from baseline to the time point the day before surgery for the population as a whole and then adjusted for by surgery type.

Secondary Outcome Measures

Change in scores on the State-Trait Anxiety Inventory (STAI) over time
The Spielberger et. al STAI is a commonly used measure of trait and state anxiety . It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It has 20 items for assessing trait anxiety and 20 for state anxiety for a total of 40 items. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "1=Almost Never" to 4="Almost Always") with a maximum score range of 40-160 when all 40 items are administered Higher scores indicate greater anxiety.
Change in scores on the Center for Epidemiologic Depression Scale (CESD) over time
The Center for Epidemiological Studies-Depression (CESD) is a 20-item measure that asks caregivers to rate how often over the past week participants experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Change in scores on the Perceived Stress Scale (PSS) over time
The PSS is a 10-item questionnaire which asks participants about feelings and thoughts during the last month. In each case, respondents are asked how often participants felt a certain way. Scores of each item ranging from 0 = "Never" to 4 = "Very Often" for a total score range of 0 to 40. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to 4 of the 10 positively stated items and scores are calculated by summing the total. Higher scores indicate higher degree of perceived stress.
Change in scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer over time
The NCCN Distress Thermometer is a single item screening tool among cancer care providers. which measures distress by asking participants to report their level of distress in the past week on a 0 to 10 scale, with a score of 0='No distress' and 10='Extreme Distress'.
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
The functional domains measure the quality of life in Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning. Scores consists of responses to items with responses ranging from 1="Not at all" to 4="Very Much". The raw score is calculated by estimating the mean of the items that make up each domains with a resulting total range of 1 - 4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the functional domains represents a high level of functioning
Change in scores on the EORTC-QLQ-C30 Global Health Status over time
The global health status score consists of responses to two items with responses ranging from 1="very poor" to 4="excellent". The raw score is calculated by estimating the mean of the two items that make up the global health scale with a resulting total range of 1-7. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the global health status represents a higher quality of life.
Change in scores on the EORTC-QLQ-C30 - Symptoms over time
The Pain score consists of responses to two items with responses ranging from 1="Not at all" to 4="Very Much". The raw score is calculated by estimating the mean of the two items that make up the pain scale with a resulting total range of 1-4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the pain scale / item represents a high level of symptomatology / problems.
Mean scores on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey
HCAHPS is a 29-item survey for measuring patients' perceptions of their hospital experience. The questions address participants recent hospital stay and contain 19 core questions about critical aspects of patients' hospital experiences (communication with nurses and doctors, the responsiveness of hospital staff, the cleanliness and quietness of the hospital environment, communication about medicines, discharge information, overall rating of hospital, and would patients recommend the hospital). The survey also includes 3 items to direct patients to relevant questions, five items to adjust for the mix of patients across hospitals, and 2 items that support Congressionally-mandated reports. Total scores are calculated by summing the items in each domain with higher scores indicating a greater overall satisfaction. A comparison of mean scores of HCAHPS survey questions between the two study groups using a two sample t-test.
Proportion of participants who completed daily meditation
Participants in the intervention arm will receive an automated text message once a week before their surgery to remind them of the daily meditation routine. Participants will then be asked to report how many days of completed meditations have been completed in the past week.
Percentage of emergency department (ED) visits at 4 weeks post-operative
The percentage of participants who visited the emergency department for an oncological related event within 4 weeks post surgery will be reported.
Rates of hospital re-admission rates at 4 weeks post operatively
The percentage of participants who were re-admitted to the hospital for an oncological related event within 4 weeks post surgery will be reported.

Full Information

First Posted
September 28, 2021
Last Updated
October 14, 2021
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05072639
Brief Title
Preoperative Guided Imagery in Patients Undergoing Urologic Surgery
Official Title
Preoperative Guided Imagery in Patients Undergoing Urologic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 25, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Cancer
Keywords
Meditation, Guided Imagery, Urologic-oncology Surgery, Anxiety reduction, Radical cystectomy, Radical nephrectomy, Partial nephrectomy, Radical prostatectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meditation
Arm Type
Experimental
Arm Description
Participants randomized to the meditation arm will receive an mp3 audio recording of the visual guided meditation will be sent an additional mp3 file specifically for the recovery phase of surgery. Participants will be asked to complete a series of pre-study questionnaires to determine their baseline anxiety, depression, stress, and quality of life scores. Subjects will then complete the same questionnaires at four additional time points: after 10 days of daily meditations, 1 day before their surgery, and day after discharge, and 4 weeks post-operation.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants received standard of care, including the option to attend a free "Prepare for Surgery workshop". Participants will be asked to complete a series of pre-study questionnaires to determine their baseline anxiety, depression, stress, and quality of life scores. Subjects will then complete the same questionnaires at four additional time points: after 10 days of daily meditations, 1 day before their surgery, and day after discharge, and 4 weeks post-operation.
Intervention Type
Behavioral
Intervention Name(s)
Guided Meditation
Other Intervention Name(s)
Meditation
Intervention Description
23 minute audio recording
Primary Outcome Measure Information:
Title
Change in scores on the State-Trait Anxiety Inventory (STAI) from baseline to day before surgery
Description
The Spielberger et. al STAI is a commonly used measure of trait and state anxiety . It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It has 20 items for assessing trait anxiety and 20 for state anxiety for a total of 40 items. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "1=Almost Never" to 4="Almost Always") with a maximum score range of 40-160 when all 40 items are administered Higher scores indicate greater anxiety. A two sample t-test will be used to compare the change between anxiety scores from baseline to the time point the day before surgery for the population as a whole and then adjusted for by surgery type.
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Change in scores on the State-Trait Anxiety Inventory (STAI) over time
Description
The Spielberger et. al STAI is a commonly used measure of trait and state anxiety . It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It has 20 items for assessing trait anxiety and 20 for state anxiety for a total of 40 items. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "1=Almost Never" to 4="Almost Always") with a maximum score range of 40-160 when all 40 items are administered Higher scores indicate greater anxiety.
Time Frame
Up to 6 months
Title
Change in scores on the Center for Epidemiologic Depression Scale (CESD) over time
Description
The Center for Epidemiological Studies-Depression (CESD) is a 20-item measure that asks caregivers to rate how often over the past week participants experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Time Frame
Up to 6 months
Title
Change in scores on the Perceived Stress Scale (PSS) over time
Description
The PSS is a 10-item questionnaire which asks participants about feelings and thoughts during the last month. In each case, respondents are asked how often participants felt a certain way. Scores of each item ranging from 0 = "Never" to 4 = "Very Often" for a total score range of 0 to 40. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to 4 of the 10 positively stated items and scores are calculated by summing the total. Higher scores indicate higher degree of perceived stress.
Time Frame
Up to 6 months
Title
Change in scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer over time
Description
The NCCN Distress Thermometer is a single item screening tool among cancer care providers. which measures distress by asking participants to report their level of distress in the past week on a 0 to 10 scale, with a score of 0='No distress' and 10='Extreme Distress'.
Time Frame
Up to 6 months
Title
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
Description
The functional domains measure the quality of life in Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning. Scores consists of responses to items with responses ranging from 1="Not at all" to 4="Very Much". The raw score is calculated by estimating the mean of the items that make up each domains with a resulting total range of 1 - 4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the functional domains represents a high level of functioning
Time Frame
Up to 6 months
Title
Change in scores on the EORTC-QLQ-C30 Global Health Status over time
Description
The global health status score consists of responses to two items with responses ranging from 1="very poor" to 4="excellent". The raw score is calculated by estimating the mean of the two items that make up the global health scale with a resulting total range of 1-7. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the global health status represents a higher quality of life.
Time Frame
Up to 6 months
Title
Change in scores on the EORTC-QLQ-C30 - Symptoms over time
Description
The Pain score consists of responses to two items with responses ranging from 1="Not at all" to 4="Very Much". The raw score is calculated by estimating the mean of the two items that make up the pain scale with a resulting total range of 1-4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the pain scale / item represents a high level of symptomatology / problems.
Time Frame
Up to 6 months
Title
Mean scores on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey
Description
HCAHPS is a 29-item survey for measuring patients' perceptions of their hospital experience. The questions address participants recent hospital stay and contain 19 core questions about critical aspects of patients' hospital experiences (communication with nurses and doctors, the responsiveness of hospital staff, the cleanliness and quietness of the hospital environment, communication about medicines, discharge information, overall rating of hospital, and would patients recommend the hospital). The survey also includes 3 items to direct patients to relevant questions, five items to adjust for the mix of patients across hospitals, and 2 items that support Congressionally-mandated reports. Total scores are calculated by summing the items in each domain with higher scores indicating a greater overall satisfaction. A comparison of mean scores of HCAHPS survey questions between the two study groups using a two sample t-test.
Time Frame
Up to 6 months
Title
Proportion of participants who completed daily meditation
Description
Participants in the intervention arm will receive an automated text message once a week before their surgery to remind them of the daily meditation routine. Participants will then be asked to report how many days of completed meditations have been completed in the past week.
Time Frame
Up to 6 months
Title
Percentage of emergency department (ED) visits at 4 weeks post-operative
Description
The percentage of participants who visited the emergency department for an oncological related event within 4 weeks post surgery will be reported.
Time Frame
4 weeks
Title
Rates of hospital re-admission rates at 4 weeks post operatively
Description
The percentage of participants who were re-admitted to the hospital for an oncological related event within 4 weeks post surgery will be reported.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sima Porten, MD,
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Preoperative Guided Imagery in Patients Undergoing Urologic Surgery

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