Urologic CancerNCT05072639
Preoperative Guided Imagery in Patients Undergoing Urologic Surgery
A study testing Guided Meditation in people with Urologic Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Cancer
- What is being tested?
- Guided Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2017to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the effect of 14 days of preoperative guided visualization meditation on patients' anxiety undergoing major urologic-oncology surgery.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Urologic Cancer
- Being tested
- Guided Meditation
- Keywords
- Meditation, Guided Imagery, Urologic-oncology Surgery, Anxiety reduction, Radical cystectomy, Radical nephrectomy, Partial nephrectomy, Radical prostatectomy
- Medical subject headings
- Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided MeditationBehavioural
Also called Meditation
23 minute audio recording
| Study group | Role | What they receive |
|---|---|---|
| Meditation | Experimental | 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. Receives: Behavioral: Guided Meditation |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 weeks
Secondary outcomes (11)
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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'.
Measured: Up to 6 months
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
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start25 Mar 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sima Porten, MD,, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072639
- Sponsor's protocol ID
- 15989
- Other IDs
- NCI-2021-10906
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Guided Imagery in Patients Undergoing Urologic Surgery
- ClinicalTrials.gov ID
- NCT05072639
- Acronym / sponsor ID
- 15989
- Conditions
- Urologic Cancer
- Keywords
- Meditation, Guided Imagery, Urologic-oncology Surgery, Anxiety reduction, Radical cystectomy, Radical nephrectomy, Partial nephrectomy, Radical prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 25 Mar 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the effect of 14 days of preoperative guided visualization meditation on patients' anxiety undergoing major urologic-oncology surgery.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation | Experimental | Behavioral: Guided MeditationParticipants 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided MeditationAlso: Meditation23 minute audio recording | Behavioural | Meditation |
Primary outcome
Change in scores on the State-Trait Anxiety Inventory (STAI) from baseline to day before surgery
Time frame: Up to 4 weeks
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.
11 secondary outcomes
Change in scores on the State-Trait Anxiety Inventory (STAI) over time
Time frame: Up to 6 months
Change in scores on the Center for Epidemiologic Depression Scale (CESD) over time
Time frame: Up to 6 months
Change in scores on the Perceived Stress Scale (PSS) over time
Time frame: Up to 6 months
Change in scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer over time
Time frame: Up to 6 months
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
Time frame: Up to 6 months
Change in scores on the EORTC-QLQ-C30 Global Health Status over time
Time frame: Up to 6 months
Change in scores on the EORTC-QLQ-C30 - Symptoms over time
Time frame: Up to 6 months
Mean scores on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey
Time frame: Up to 6 months
Proportion of participants who completed daily meditation
Time frame: Up to 6 months
Percentage of emergency department (ED) visits at 4 weeks post-operative
Time frame: 4 weeks
Rates of hospital re-admission rates at 4 weeks post operatively
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sima Porten, MD, principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Meditation in people with Urologic Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores on the State-Trait Anxiety Inventory (STAI) from baseline to day before surgery (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.