AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in United States

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:

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

SECONDARY OBJECTIVES:

  1. 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 groups in NCT05072639
Study groupRoleWhat they receive
MeditationExperimentalParticipants 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 groupNo interventionParticipants 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  1. First posted11 Oct 2021
  2. Study start25 Mar 2017
  3. Primary completion30 Sep 2019
  4. Study completion30 Sep 2019

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in