Understanding Women’s Anxiety and Uncertainty Attending a Rapid Diagnostic Clinic for Suspicious Breast Abnormality: A Mixed Methods Study

Background : Rapid diagnostic centres (RDC) for breast abnormality oﬀer a speedier process from the discovery of a suspicious breast lump to same-day investigation and conﬁrmation of a breast cancer diagnosis. Purpose : This proof of concept study aimed to assess the anxiety and uncertainty levels of women going through an RDC and explore women’s need for support during the diagnostic period. Methods : Thirteen women who attended an RDC in 2013 took part in a sequential mixed-method study to assess anxiety and uncertainty levels. Measures were taken pre-and post-testing, at three weeks following receipt of results, and were followed by a semi-structured telephone interview. Results : The mixed data results show congruence between women scor-ing above clinical values for anxiety and above normative values for uncertainty and detailing their RDC experience as stressful. At pre-diagnosis, uncertainty and anxiety levels were above clinical and normative values for the majority of thethirteenwomen. Amongthewomenwhoreceivedacancerdiagnosis(7/13), ﬁve had high anxiety, and two scored above normative values for uncertainty. Among the women with a benign diagnosis (6/13), all had anxiety scores below clinical levels, and three had scores above normative values for uncertainty. Anxietyanduncertaintylevelsremainedrelativelythesamefromthethreedays to three weeks post-testing. The women suggested the need to receive details of the day’s unfolding, especially what medical procedures will take place, how, and why, and in advance of the day of testing. Conclusion : While RDCs oﬀer women with a suspicious breast lump the opportunity for quicker diagnostic testing, preliminary results suggest that the period leading up to the day of testing and three days and three weeks post-testing is marked with anxiety and uncertainty levels above clinical and normative values. The results illustrate the need for further inquiry into the psychological impact of obtaining testing at RDCs for a breast abnormality. Results suggest a potential role for nurses to support the waiting period with psycho-educational guidance and resources.


| INTRODUCTION
During the diagnostic period after a breast lump is discovered or a mammogram displays suspicious findings, women experience significant psychological distress, including anxiety, uncertainty, and symptoms of acute stress reaction. (1)(2)(3)(4)(5) A systematic review of thirty research studies with large sample sizes examining the presence of anxiety levels in the diagnostic period for women suspected of breast cancer found that, on average, 8% to 50% experienced high levels of anxiety. (2) The high anxiety was also found to persist throughout the diagnostic evaluation until certitude was achieved by establishing the definitive diagnosis. (6) Such high levels of anxiety can easily disrupt an individual's ability to maintain their everyday activities and are also documented as having a negative effect on the immune system. (7)(8)(9) Pre-diagnostic anxiety is a significant predictor of post-diagnostic anxiety that can impact a person's ability to cope and have implications for adverse longterm outcomes. (2,10) Although the diagnostic phase can be marked with intense emotional distress, this phase is often overlooked in research. (3,11) Rapid diagnostic centres (RDCs) or one-stop clinics were developed to improve the diagnostic process for women and offer same-day investigation and a quick turnaround for a diagnosis of breast cancer (same day to three days post-investigation). (3,12) Conceptually, the idea of RDCs for women with suspicious breast abnormalities is attractive, especially to reduce wait times to diagnosis. (13) However, for the few studies that have investigated the psychological impact of rapid diagnostic testing for breast cancer, the consensus remains unclear regarding its effects on the individual's anxiety, uncertainty, and stress (3,4,(14)(15)(16); nonetheless, current longitudinal evidence is pointing towards a positive association between symptomatic breast disease and psychological distress. (2,4,17) In addition, there is limited information on whether receiving psychological support during the rapid diagnostic process is needed and valuable, and if so, in what forms. (18) The objectives of this proof of concept study were to assess these outstanding gaps by measuring and describing the levels of anxiety and uncertainty as experienced by women undergoing rapid diagnostic testing for a suspicious breast abnormality before and after testing and exploring the women-expressed needs for support during the diagnostic period.

| THEORETICAL MODEL
The Mishel Uncertainty in Illness model guided this study. (19) Mishel ((19), p. 225) defines uncertainty as "the inability to determine the meaning of illnessrelated events." Uncertainty arises when a person cannot characterize an event because of insufficient cues. This inability may be especially acute in a complex situation, such as a diagnostic workup, where the patient is overwhelmed with an abundance of unfamiliar cues.
When a situation is appraised negatively, uncertainty is viewed as a threat rather than an opportunity. In these instances, uncertainty becomes a covariate of anxiety. (20) Thus, one can anticipate that a reduction in uncertainty could, in turn, lead to a reduction in anxiety. (4,21)

| METHODS
The setting for this preliminary proof of concept study occurred in an RDC situated in a large Canadian cancer research, treatment, and educational centre. The study followed a sequential mixed-method design. A quantitative phase was first used, followed by a qualitative phase to describe and understand the anxiety and uncertainty experienced by women undergoing rapid diagnostic testing for a suspicious breast abnormality. The quantitative data were collected at three-time points [at prediagnosis (T1), three days post-diagnosis (T2), and three

| Sampling
Inclusion criteria included women from the hospital's catchment area who had a suspicious breast abnormality that was detected radiologically or clinically, with no previous history of breast cancer diagnosis, who had an appointment at the RDC and did not have a known history of BRCA1/BRCA2 mutations. Women were excluded if they did not read or speak English, were less than 18 years of age, had a recent fine needle aspiration that was suspicious for malignancy, or had preexisting anxiety or major depressive disorder diagnosis. A convenient sampling approach was used to select women. Women who met the inclusion criteria were identified and approached initially by the clinic's medical administrative assistant using an information script.
If the women were interested in participating, they were asked for verbal permission to forward their name and telephone number to the study research assistant, who arranged for and conducted the informed consent process. Only those that provided written consent were included in the analysis. Twenty-four women were approached for the study. In total, 13 women met the eligibility criteria and agreed to participate. Reasons for declining were not interested in the study and could not commit time to conduct the interview.

| Data Collection and Measures
The quantitative data collected included demographics and two validated scales measuring uncertainty and anxiety. Uncertainty was measured using Mishel Uncertainty in Illness Scale -Community form (MUIS-C).

| Data Analysis
Quantitative data: The statistical software SPSS 20 was used to generate percentages, means, standard deviations, and reliability scores (Cronbach's alpha), as well as non-parametric statistical analyses to test for significance and correlation from the quantitative data generated from the study survey: MUIS-C (uncertainty outcome) and STAI-S (anxiety outcome). Descriptive statistics were used to summarize the participants' characteristics and levels of uncertainty and anxiety. Pearson correlation coefficient was used to test the association between anxiety and uncertainty levels.
Qualitative data: Qualitative data generated from the semi-structured interviews were transcribed verbatim Maheu and coded using content analysis (29,30) to develop the categories and themes that represented the aggregate data. Three members (CM, CW, DH) independently coded the data. Interview coding continued until a consensus of coding categories and thematic saturation was reached.

Triangulation of Quantitative and Qualitative Data:
This study followed a mixed, quantitative-qualitative, sequential analytical approach in which the quantitative data was dominant and analyzed first, followed by the analysis of the qualitative data, used as an adjunct to understand the quantitative findings further.

| RESULTS
The thirteen women who took part in the study are representative of the general population seen at the RDC.
They had a mean age of 50, had an average of two children, the majority were married (n=8/13) and universityeducated (n=8/13). While about 15%-20% of all breast cancer cases tend to be familial (32), in this sample, there was a higher sample of women with a family history of the diseases (n=7/13). Following testing, among the 13 women, seven were found with a malignant tumour and six with a benign tumour.
At the pre-diagnosis, nine out of thirteen women scored above the clinical values for symptoms of state anxiety and all thirteen scored above normative values for the state of uncertainty (normative mean value = 33.7, standard deviation + 12.9; a range of 23-115) (see Table 1). A two-tailed Pearson correlation coefficient test between anxiety and uncertainty revealed a strong association of 0.757 (p=0.003).
The following categories separate the triangulated re-sults from the quantitative and qualitative data to reveal themes that could help explain their emotional experience: 1) by the time of diagnosis from pre-diagnosis to three days and three weeks post-diagnosis and 2) by below and above clinical and normative values for anxiety and uncertainty. The clinical nurses' explanations as to why further tests were needed were mentioned as helpful to reduce uncertainty and anxiety.

| Pre-diagnosis: Above clinical values for both anxiety and uncertainty
For both groups of women with a malignant and benign diagnosis whose scores were above clinical values at pre-diagnosis for anxiety (n = 9/13) and uncertainty (n = 13/13), two themes best describe their experiences: 1) additional testing generating uncertainty, and 2) concern over maintaining responsibilities.

Participant 5
In expecting the worst-case scenario, these women  This is not going to be great" (Participant 8). Women went through additional testing such as a biopsy to obtain their diagnosis. One woman described this experience as a "funeral moment".

| Three days post-diagnosis: Above clinical values for anxiety and uncertainty among the women who received a benign diagnosis
Among the women who received a benign diagnosis (n = 6/13), all had anxiety scores below clinical levels, and three had scores above normative values for uncertainty.
Two themes describe their experience post-diagnosis for this subgroup: a) absolute relief and b) adjusting to the diagnosis.

| Three weeks post-diagnosis: Above clinical values for anxiety and uncertainty
Anxiety and uncertainty levels remained relatively the same for both groups of women with a malignant and benign diagnosis from three days to three weeks posttesting. There was, however, an increase noted in the benign group, with two now experiencing anxiety above the clinical levels and an additional woman experiencing uncertainty above normative values. The two women who now experienced high anxiety at three weeks posttesting described that they expected to receive a cancer diagnosis eventually.

| The need for support during the diagnostic period
The women suggested the need to receive details of the day's unfolding, especially what medical procedures will take place, how, and why, and in advance of the day of testing. They wanted to know if they needed to take pain medication prior to their clinic appointment for further testing and if it was best to be accompanied. On the day of receiving their results, half of the women shared needing more information on their diagnosis, such as a written report on the stage of their diagnosis. One suggestion was to provide a lecture on breast cancer diagnosis and the possible stages that might be found, which was seen "as a way to brace [themselves]" (Partic- After all, as one woman shared, "we are here all day getting tests done, waiting for the results at the end of the day with the possibility of being told we have cancer. It is a lot to take in alone."

| DISCUSSION
The study findings bring further insights to several cur-

| Recommendations for Research
This study was explorative and a proof concept. There

| Study Limitations
Like many other studies investigating the clinical and psychological impact of RDCs (16), this study's findings are constrained by its small sample size and with more than half of the sample having a family history with the disease. Given that this profile may not represent the general population, further research is needed to assess the associations between family history of cancer and anxiety levels and the need for genetic counselling and psychological support among those attending RDCs.
This study was carried out in one cancer center offering rapid diagnostic testing for women with a suspicious breast lump, and the above profile may not represent other RDCs. However, the strengths of the mixedmethods findings contribute significantly to our empiri-