Clinical trial NCT02796612: Empathy and Standard Diagnostic Procedures in an Outpatient Breast Clinic Might Not be Enough
Official title: Empathy and Standard Diagnostic Procedures in an Outpatient Breast Clinic Might Not be Enough
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: anxiety
breast cancer, suspected
breast biopsy
empathy
standardized and structured information
anxiety reduction
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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 %.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* women receiving a fine needle Aspiration
* women receiving an examination of a pathologic nipple secretion
* women receiving an abscess evacuation
* women who do not speak and understand German

Primary outcomes:
measure: Reduction of level of anxiety compared between arm 'no intervention' and arm 'intervention' as measured via questionnaires
timeFrame: up to 19 months
Secondary outcomes:
measure: level of anxiety in the intervention group during and after biopsy measured via questionnaires
timeFrame: up to 19 months
measure: correlation of the level of anxiety and the histological diagnosis of breast cancer measured via questionnaires
timeFrame: up to 19 months
measure: perception of pain during and after biopsy measured via pain score
timeFrame: up to 19 months
measure: influence of waiting time between biopsy and histological diagnosis on the level of anxiety measured via questionnaires
timeFrame: up to 19 months
measure: correlation of patient's perception of pain and anxiety and physician's impression of patient's perception measured by questionnaires
timeFrame: up to 19 months
measure: patient's satisfaction with additional information concerning biopsy measured by Visual Analog Scale
timeFrame: up to 19 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital of Basel
state: Basel-Stadt
city: Basel
country: Switzerland
facility: Claraspital
state: Basel-Stadt
city: Wetzikon
country: Switzerland
facility: GZO Wetzikon
state: Zürich
Study officials:
affiliation: Claraspital Basel
name: Rosanna Zanetti, PD Dr. MD
role: PRINCIPAL_INVESTIGATOR
References: