Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Anxiety Disorders

Breast Neoplasms

Mental Disorders

Psychotic Disorders

Patients receive the current standard of care and are asked to answer the questionnaires mentioned below.

Patients receive the current standard of care and are asked to answer the questionnaires mentioned below.

Additionally, delivery of a take-home brochure to the patients during the first visit is planned. The biopsy is explained to the patient and performed by a psychological trained physician. Patient care by a psychologically trained physician is performed in the sense that patients are informed about their biopsy result by a specifically trained physician.

Patients do not receive any interventions but are treated according to current standard of care.

no intervention

Content of brochure is dealing with symptoms, as well as mammographic and ultrasound findings, which need further investigation, will be addressed. The procedure of the breast biopsy itself will be explained in detail. The time in which the histological diagnosis can be expected will be indicated and follow up in case of a benign histology and the necessary therapy in case of breast cancer will be addressed.

delivery of a take-home brochure

The physicians who perform the biopsies will be instructed by means of a psychological training how to give structured and standardized information in order not only to inform comprehensively, but also to meet the patients' emotional needs.

patient care by a psychologically trained physician

Rosanna Zanetti, PD Dr. MD

The project investigates prospectively whether anxiety in the context of breast biopsy can be reduced by the planed intervention (take-home brochure and structured and standardized information given by a psychologically trained physician who performs the biopsy).

The fact having to have a breast biopsy taken due to suspected breast cancer is an emotionally exceptional situation not only because of the threat to be diagnosed of cancer but also because the breast is perceived as a symbol of womanhood, sexuality and motherhood.

Time, however, is scarce in a busy outpatient setting. Nevertheless doctors and nurses at the outpatient breast clinic University Hospital Basel are empathetic and try to address anxiety and give emotional support before, during, and after a necessary breast biopsy. Study findings, however suggest, that the level of anxiety, pain and discomfort associated with breast biopsies is considerable, which might not be sufficiently controlled by empathy alone but might be reduced by giving structured and standardized information.

The investigators hypothesize that the planned intervention reduces the level of anxiety in patients going for breast biopsy and thus is superior to the current standard of diagnostic procedures.

The project focuses on improving the patients' knowledge about the procedure of breast biopsy and on meeting their emotional needs to reduce anxiety related to the biopsy by giving structured and standardized information. Additionally the project investigates whether patients diagnosed with breast cancer have a higher level of anxiety than patients with benign breast disease. Furthermore the study assesses how precisely the physicians, who perform the biopsy, appraise the patients' perception of anxiety, pain and satisfaction related to the breast biopsy.

The primary objective is to demonstrate that the intervention reduces the patients' anxiety compared to the standard of care.

The intervention consists of (1) handing out a take-home brochure to the patient as well as (2) providing structured standardized information about the biopsy by the physician who performs the biopsy and who underwent psychological training for this purpose.

Secondary objectives are:

Does the intervention reduce anxiety during and after biopsy? Is there a correlation of the level of anxiety and the histological diagnosis of breast cancer? Does the waiting time between the procedure and the histological diagnosis have any influence on the level of anxiety? How is the patient's perception of pain during and after the biopsy? Is there a correlation between the patient's perception of pain and anxiety and the physicians' impression of the patient's perception? Is the patient satisfied with the additional take-home brochure and / or the structured and standardized information giving? This is a prospective study to evaluate anxiety before and after the implementation of a structured intervention to reduce anxiety related to breast biopsy.

Eligible are women who speak and understand German and will need a skin biopsy, core biopsy or a vacuum assisted biopsy.

Women receiving a fine needle aspiration, examination of a pathologic nipple secretion, and abscess evacuation will be excluded.

Women who do not understand or do not speak the German language will be excluded.

Demographics and relevant baseline variables will be summarized for both groups of patients. Categorical data will be presented as frequencies and percentages. For continuous variables, the lower and upper quartile as well as the median will be presented. Baseline characteristics of the two groups will be compared using the proportion test for categorical variables and the Welch two-sample t-test for continuous variables.

Anxiety of patients will be measured at four points in time with State-Trait Anxiety Inventory (STAI): before and after biopsy as well as before and after the communication of the diagnosis. The difference in STAI score between patients receiving standard of care and patients with intervention will be compared using Wilcoxon's rank sum test (Mann-Whitney test) at a significance level of α = 0.05. The results of the questionnaires will be reported as estimates together with the 95% confidence interval. Secondary objectives will be assessed using non-parametric tests if appropriate.

Sample size was estimated to be able to detect a significant difference in anxiety measured by the State-Trait Anxiety Inventory (STAI) score (Spielberger, Consulting Psychologists Press (CPP) 1983) between the group receiving standard of care and the intervention group. In a recent study, Flory et al. (Flory and Lang) reported a mean STAI score of 48 points for breast biopsy patients which were used here to simulate data for the control group. By assuming an effect size of 5 score points, a mean score of 43 points was used for the patients with intervention. The scores of both groups were assumed to be normally distributed with a standard deviation of 11.9.

Sample size was calculated with a semi-parametric resampling method. Each sample size ni, was evaluated by simulating R=999 times ni individual patients from the above distributions. The scores of the two groups were compared using Wilcoxon's signed-rank test at a significance level of α = 0.05. Sample size was set to ensure at least a power, 1 - β, of 0.9.

For this study, totally 334 patients should be recruited to ensure 250 evaluable patients considering a drop-out rate of 25 %.

Empathy and Standard Diagnostic Procedures in an Outpatient Breast Clinic Might Not be Enough

University Hospital, Basel, Switzerland

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Diseases

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.

Guided Meditation

Sima Porten, MD,

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.

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.

Preoperative Guided Imagery in Patients Undergoing Urologic 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.

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.

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.

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.

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'.

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

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.

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.

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.

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.

The percentage of participants who visited the emergency department for an oncological related event within 4 weeks post surgery will be reported.

The percentage of participants who were re-admitted to the hospital for an oncological related event within 4 weeks post surgery will be reported.

University of California, San Francisco

Patients randomized to the music intervention arm will select a preferred genre of music from an internet based resource.

These patient's will have no music playing during the first radiotherapy session.

The patient's preferred music will be played during the first radiotherapy treatment session from speakers located inside the treatment room. The duration of the music will be 10 to 20 minutes. The music will be turned off at the patient's request if it bothers them. Length of music playing and if the patient requested that it be turned off, will be recorded.

Music

Natalie A. Lockney, M.D.

The primary hypothesis of the study is that listening to music will reduce anxiety in female cancer patients during the first radiotherapy treatment session.

Receiving radiotherapy induces anxiety in at least 1/3 of patients who did not have a previously existing anxiety condition1. Female gender is a positive predictive factor for psychosocial decline during radiotherapy. One-fourth of patients disrupt their planned radiotherapy treatment course due to anxiety. Music therapy has demonstrated effectiveness in reducing anxiety when implemented in other medical settings including mechanical ventilation, burn debridement and venipuncture in pediatric patients. There have been some trials which have found a reduction in anxiety when pre-recorded music along with other relaxation techniques have been implemented during radiotherapy. This trial seeks to investigate the benefit of pre-recorded music alone in reducing anxiety experienced during the first radiotherapy treatment session in female cancer patients.

Consented, eligible female subjects to be randomized to "Music" or "No Music" to evaluate pre and post treatment anxiety level via STAI and SDT anxiety questionnaire at their first radiotherapy treatment for cancer.

Multiple studies document a higher rate of psychological distress in female cancer patients.The study is limited to females to decrease confounding prognostic factors related to anxiety during cancer therapy. By restricting enrollment to women in this study, is to gain proof of concept that the intervention is effective and can be determined with a smaller sample size.

Music of Choice to Decrease Anxiety During Radiation Treatment

A Randomized Trial of Music to Decrease Anxiety in Women Starting Radiation Therapy for Cancer

Percent change in mean anxiety score as measured with the State-Trait Anxiety Inventory (STAI) questionnaire. Assessed by the mean value (pre minus post radiotherapy STAI score) divided by mean pre-treatment score multiplied by 100. A score of 39-40 on each subset suggests clinically significant anxiety.

Percentage change in mean anxiety score as measured with the Symptom Distress Thermometer (SDT). Scale of 0 - 10; with 10 being clinically significant distress.

The magnitude of change in anxiety score of STAI in "high anxiety" patients (pre-treatment STAI ≥ 40) as a result of listening to music during the first radiotherapy session.

The magnitude of change in anxiety score of SDT in "high anxiety" patients (pre-treatment SDT ≥ 4) as a result of listening to music during the first radiotherapy session. Scale of 0 - 10; with 10 being clinically significant distress.

The number and percentage of patients who drop from a "high" to "low" anxiety level in both intervention groups using STAI scores. A score of 39-40 on each subset suggests clinically significant anxiety.

The number and percentage of patients who drop from a "high" to "low" anxiety level in both intervention groups using SDT scores. Scale of 0 - 10; with 10 being clinically significant distress.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Empathy and Standard Diagnostic Procedures in an Outpatient Breast Clinic Might Not be Enough	NCT02796612	Anxiety	no intervention delivery of a t... patient care by...	18 Years -	University Hospital, Basel, Switzerland
Preoperative Guided Imagery in Patients Undergoing Urologic Surgery	NCT05072639	Urologic Cancer	Guided Meditati...	18 Years -	University of California, San Francisco
Music of Choice to Decrease Anxiety During Radiation Treatment	NCT03527225	Anxiety Cancer	Music	18 Years -	University of Florida
Preoperative Guided Imagery in Patients Undergoing Urologic Surgery	NCT05072639	Urologic Cancer	Guided Meditati...	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for anxiety reduction