Exploring the prevalence and experience of mask anxiety for the person with head and neck cancer undergoing radiotherapy

Abstract Introduction While use of a thermoplastic mask during radiotherapy (RT) treatment for head and neck cancer (HNC) is an essential component of safe patient care, there is little understanding of the extent to which this evokes anxiety (i.e. “mask anxiety”) for the person undergoing treatment. Methods A mixed method, convergent design was used to examine the prevalence and experience of mask anxiety using two clinical cohorts. In phase one, a cohort of 100 patients undergoing RT for HNC were assessed for self‐perceived mask anxiety using a modified distress thermometer screening tool. In phase two, a separate cohort of 20 patients who identified as having mask anxiety participated in individual interpretative descriptive interviews to explore the nature of their experience. Results In phase one, 26% of participants self‐identified as being anxious about the use of a thermoplastic mask. In phase two thematic analysis of the interviews revealed two over‐arching themes relating to the person's experience of mask anxiety: contributors to the mask anxiety (vulnerability, response to experience and expectations); and how the person was going to manage the mask anxiety during treatment (strategies and mindset). Conclusions Mask anxiety impacted a quarter of participants undergoing radiotherapy for HNC. In line with the themes elicited from the participants, implementation of routine screening to ensure early identification, and patient education to assist preparation for wearing the mask during RT are strategies that could improve current management of mask anxiety.


Introduction
To ensure precise radiotherapy (RT) delivery to sites of disease and avoidance of surrounding structures, patients with head and neck cancer (HNC) are immobilised during their treatment with a thermoplastic mask. 1 Patients may experience anxiety and distress, which can impact on the accuracy, precision, and delivery of RT for HNC. 2 There is little data about the prevalence of anxiety and distress associated with wearing a thermoplastic mask nor about the experience of the person who identifies as having mask anxiety during RT.
Use of the mask is unique to RT for HNC, brain and some upper chest cancers, and there are significant consequences if treatment cannot be delivered due to problems wearing the mask. In a previous study, patients with HNC identified wearing the mask was one of the worst parts of RT. 3 In the only study conducted to date to explore rates of mask anxiety, the incidence of mask anxiety ranged from 16% to 24% (n = 70) depending on whether it was identified using a general distress tool (16%), or identification by a radiation therapist (24%). 4 In research conducted by the same group, radiation therapists rated disruption to sessions on a scale of 1-5, and found an 11% rate of disruption to CT simulation and a 24% rate of disruption to Day 1 of treatment was attributed to mask anxiety. 2 There has been limited exploration of the experience of mask anxiety for the person with HNC. One study interviewed a heterogenous cohort of 19 people immobilised for RT (only five participants were being treated for HNC) and found low anxiety associated with the mask, however, those with a pre-existing phobia were more likely to experience distress. 5 A pilot qualitative study of three HNC patients undergoing RT, revealed themes of physical discomfort of the mask; the mental perception of the mask; and, the passivity of accepting that it was part of the treatment, however, participants with mask anxiety were specifically excluded in that study. 6 Thus, the paucity of evidence surrounding incidence of mask anxiety specific to HNC and the patient experience indicates the need for further exploration.
This study firstly aimed to examine the prevalence of mask anxiety for people undergoing RT for HNC and secondly explored the experience of the person who identifies as having mask anxiety.

Study design
This study used a mixed method convergent design which utilises both a quantitative and qualitative approach to explore mask anxiety. 7 Phase one used a cross sectional quantitative design to determine the incidence of mask anxiety. Phase two employed a qualitative process of interpretative descriptive design to explore patient perceptions and experiences of mask anxiety to further understand the results of the phase one study. 8 The two phases utilised independent recruitment processes and cohorts. This study was conducted at a single, quaternary hospital in Brisbane, Australia. Ethical clearance was received from the Metro South Hospital Research Ethics Committee (HREC/13/QPAH/437). All participants provided informed written consent.

Phase One
Recruitment targeted a cross-sectional sample of HNC patients who were booked for routine, weekly appointments with the multidisciplinary team (radiation oncologist, speech pathologist and dietitian). These participants were involved in a concurrent study investigating general distress, swallow and nutrition, and were scheduled to receive RT with curative-intent treatment. 9 Three one-week periods of recruitment were conducted, with at least 6 weeks in between recruitment windows to ensure recruitment washout, thus limiting participants' entering data more than once during the course of their RT. Patients with severe cognitive deficits, inability to read/write English, significant vision, hearing or physical dexterity impairments which would limit use of a self-administered electronic screening tool were excluded from the study. Recruitment was conducted from October 2014 to May 2015.

Phase two
Recruitment occurred over a fixed 12-month time frame between March 2016 and March 2017. Patients were included if they were having RT for HNC and identified distress/anxiety with the use of the mask either via the departmental, self-administered electronic screening tool with a score greater than 4 of 10, 10 or referral from nursing, medical or RT staff and were referred for occupational therapy intervention, as is standard care for mask anxiety in our centre. During the data collection period of phase two, our centre was implementing self-administered electronic screening for HNC patients weekly during RT. As such, both standard care referrals from the MDT and electronic screening tool referrals were used as entry points into services for mask anxiety. During their initial occupational therapy appointment patients were offered the opportunity to participate in this study. Recruitment closed at the completion of the 12-month period. Patients who had severe cognitive deficits or significant hearing impairments which would limit participation in an interview were excluded from the study.

Phase one
No validated tool exists to measure mask anxiety. The distress thermometer (DT) is a widely used tool which has been validated for use in multiple cancer conditions and countries. 10,11 The DT was modified specifically to question distress related to mask anxiety: "Please circle the number (0-10) that best describes the level of distress you feel about having to wear the thermoplastic mask for radiotherapy?" (Fig. 1). As is consistent with the DT, a cut-off score of 4 or above was considered a trigger for referral for support. 10,12 The DT modified to assess mask anxiety was completed at one time-point between

Phase two
A single semi-structured interview was conducted either post-planning, or during the first week of RT. This interview included open-ended questions to explore the participant's experience of distress/anxiety related to the experience of being fitted for the mask at planning, and the preparedness to commence treatment. 13 A twoquestion interview guide, with exploratory probes was designed based on current literature and expert clinical knowledge (Appendix I). The questions were trialled on five patients and were considered to elicit information that was relevant to the research question. Interviews were conducted either by the principal investigator (JN) or a senior occupational therapist with both having extensive clinical experience with this cohort. The interviewer was not previously known to the participants. Interviews were conducted as per patient preferencevia phone, face-toface or with a carer present. All interviews were audiorecorded and transcribed verbatim for analysis.

Phase one
Descriptive statistics were used to analyse the participant characteristics and prevalence of mask anxiety. In the absence of any prior use of a validated tool to measure mask anxiety, or a mask specific DT, mask anxiety was considered if a score was equal or greater than 4 as is usual with the DT. [10][11][12] Phase two Interviews were transcribed verbatim by an independent research assistant. Thematic analysis was conducted by the research teamthe principal investigator (JN) and another HNC specialist (BC) who was not involved in the interview process. Thematic checking was conducted by two other members of the research team (JT, AP) for consistency and consensus. Thematic analysis of the interviews was conducted using an interpretative descriptive design as proposed by Thorne. 8 All team members have extensive experience working with the HNC population, the RT process, and the support required to manage mask anxiety, and this expertise was utilised as recommended by Thorne. 8 Initial thematic analysis took place by concurrently listening to and reading the transcripts. A four-step cognitive process of data analysis was undertaken: (1) comprehending the themes discussed by participants; (2) finding patterns that were similar; (3) reflecting and manoeuvring these findings for (a) the individual and (b) in relation to the group; and finally (4) reconceptualising how these themes may be used in other contexts and settings, and how to move this from theoretical contexts to that of clinical practice. 8,14 Initial themes were discussed in the research team, refined, and collapsed/expanded until consensus was reached. Simple percentages were used to reflect the proportion of the cohort who raised particular themes/subthemes.

Phase one
Concurrent study participant details have previously been described in Wall et al. 9 and their details were summarised in Table 1. One hundred participants were recruited over an 8 months time-frame. A high percentage of participants were male (n = 80), with a mean age of 63 (SD = 12, range 34-93 years), most being treated for oral cavity/oropharyngeal cancers using surgery and postoperative radiotherapy or concurrent chemoradiotherapy. All participants required the use of a thermoplastic mask including shoulder immobilisation during RT.
Cross-sectional sampling for mask anxiety was completed through the course of RT, with participants having completed a mean of 64% of prescribed RT when recruited (SD = 19). 9 The prevalence of patient-reported anxiety associated with the use of the thermoplastic mask at any time during RT for HNC was 26%. Of this, 20% of participants indicated moderate distress (score 4-7 on the mask anxiety DT) and, 6% with severe distress (score 8-10 on mask anxiety DT).

Phase two
A time-convenience sample of 20 participants who were mostly male (n = 15), receiving post-operative RT for HNC with mean age of 62 participated in an interview ( Table 1). The majority of interviews (n = 19) were conducted over the phone and ranged between 5 min and 1 h in duration. Two participants had a carer present for the interview. Thematic analysis of the interviews revealed two over-arching themes with five subthemes (Fig. 2). There were three subthemes that discussed the participants experience and contributors to the feelings of mask anxiety (Table 2), and two subthemes that discussed the participant's preparation for how they were going to manage the mask (Table 3).
Themes related to the participant experience of mask anxiety

Theme 1
Vulnerability (Table 2) Participants discussed three subthemes that contributed to their apprehension about managing the confinement of the mask for RT. The first was a pre-existing claustrophobia (n = 14) that contributed to apprehension about how they would manage: "Yeah well it first started when I was doing some bricklaying by trade, and I did some bricklaying in the back of a boiler and because it is a confined space. . .. everything started closing in on me and I panicked and that is when I first noticed it" (P262). The second subtheme was that of pre-existing psychological/ mental health issues (n = 11) that contributed to anxiety/ panic in new situations: "I guess my heightened awareness of the environment, is something I am aware of. . . I started off with knowing that my reaction is this situation was always going to be difficult to manage" (P273). The third subtheme participants discussed was concurrent stressors which either heightened their response to the mask or existed alongside the mask anxiety (Table 2). More than half of the participants (55%) discussed other stressors that were equally or more concerning than the mask. This ranged from concerns regarding side-effects of treatment such as mouth opening and breathing, to practical issues such as housing and transport during treatment, and concerns regarding disease progression and whether the treatment would be effective.

Theme 2
Responses to experience (Table 2) Participants discussed a combination of psychological and physiological responses to the process of having the mask made during the planning session: "When I'm. . .thinking about. . .the frame, head, mask thing (pause), the anxiety came up. . .and then the racing breath, you know, the sweating feelings" (P273). This response to the mask being made during the CT simulation was a contributor to the participants' concerns about how they would manage the mask for the course of the RT. Participants also reported an emotional response of helplessness/ powerlessness ( Table 2). Half of the group reported feelings of not being in control, with one participant likened it to "being buried alive" (P279). Another described "I mean imagine someone behind you with their hand clamped across your mouth and you cannot open it or move it. It's an awful feeling" (P267). This description of not being in control of a situation was overwhelming for this group.

Theme 3
Expectations of treatment (Table 2) Participants were aware they had to have the mask, but some still accessed "Dr Google" (n = 3) to find out more about the process. They felt unprepared regarding the experience of being fitted for the mask, or the process involved was unexpected: "They did tell me about it on a previous visit but I didn't realise it was so rigid and restrictive and that it is actually clipped to the bed of the scanner" (P267).  (Table 3) There were six subthemes which related to strategies for managing the mask during the RT: (1) practical strategies -70% of the group identified practical strategies that they were going to use, this included using music, having the eyes or mouth cut out of the mask, and waving their hand to stop treatment if needed; (2) patient initiated strategies (n = 13)where participants discussed techniques that they were using/going to use, "I've been doing lots of self-talk and you know, visualisation and I'm fine with it now"(P271); (3) pharmacological-60% of participants discussed this as an option to help get through treatment, however, it is worth noting that 5 of 12 participants who discussed this did not want the medication as they did not like how it made them feel/ could not drive/did not want to take anything extra; (4) psychological/cognitive strategiesparticipants discussed a number of ways that they were seeking external support to learn meditation/calming thinking, use of spiritual methods of prayer or using personal cognitive strategies; (5) support of others -50% of participants discussed the value of support from others, this ranged from family members, doctor, but was mostly referencing the support of the radiation therapist talking to them during the planning/treatment process; and (6) experience of others -15% of participants discussed that they had found it useful talking to other people who had been through the experience of using the mask.

Theme 5
Mindset (Table 3) Participants discussed four different mindsets relating to their ability to manage the mask during RT. A larger number (50%), discussed a pragmatic response of selfdetermination, "I understand that it's going to be up to me, I'm the only one that can put myself through it"

Discussion
Using the DT modified for mask anxiety, the study found that from a cohort of 100 people, 26% of patients identified distress with the mask, which is slightly higher than the previously reported prevalence. 2,4 This may be due to the use of a more targeted tool for data collection of mask anxiety, whereas previous studies have used more generalised anxiety measures, or it could be a reflection that mask anxiety may change through the treatment process, not isolated to CT simulation or Day 1 of RT as previously investigated. 2,4 In procedures where patients have felt confined, such as during MRI, it has been reported that 35-37% of people feel anxious. 15,16 With this level of anxiety and distress being experienced in cancer treatments and procedures requiring confinement, this is a phenomenon that needs closer examination of how to best support patients. This study explored the experience of people undergoing treatment for HNC who identified as having mask anxiety, revealing two over-arching themes: participants discussed how prepared they were for the mask fitting; and, they discussed the strategies they were going to implement to cope with the experience of having the mask during RT.
The first over-arching theme relates to the contributors to mask anxiety. This group discussed their vulnerability of being claustrophobic, having pre-existing psychological/ mental health issues and other concurrent stressors as contributors to mask anxiety. These patient-reported contributors are consistent with the five factors that Clover and colleagues reported which contributed to planning disruption in a group of 90 participants undergoing HNC treatment (taking psycho-active medication, fear of enclosed spaces, fear of face covered up, fear of movement restriction and ever had an anxiety attack). 2 As mask anxiety has been found in two sample populations, routine screening for mask anxiety may be warranted. Those affected may benefit from increased support either prior to planning or commencement of treatment. Future investigations are needed to examine whether proactive referrals better prepare patients for treatment resulting in less disruption during the RT process.
The second over-arching theme is that of the strategies participants proposed to manage mask anxiety during the RT. The majority of participants discussed psychological strategies such as the use of self-talk, relaxation and cognitive behavioural strategies and practical strategies such as eyes of the mask being cut out, and the use of music as being effective. Previous studies have supported the use of music as being beneficial to moderate anxiety level during radiotherapy. 17,18 Another strategy that participants reported as useful, with strong support in both RT and MRI literature is that of staff communication and providing concrete objective information about the process. 19,20 A study by Tazegul et al. 19 in patients undergoing MRI showed that information and communication reduced anxiety both on a biochemical and psychiatric level. A clinical consideration would be to offer patients the opportunity to listen to music, access support or counselling, and for RT staff to be trained in communicating with anxious patients to help reduce and support the anxiety related to this procedure.
The use of medication is another strategy discussed by participants and recommended by other studies. 2 However, a high proportion of participants discussed the preference to not use medication if not essential. A clinical consideration would be to use the above strategies either in conjunction with or as an alternate option to medication as per the person's request.
There are a number of limitations to this study. The prevalence of mask anxiety was established at different times during the RT process, which may not capture the extent of mask anxiety at all stages of treatment. Future studies should utilise a prospective data capture design at planning, week one, and then weekly during the course of treatment to observe patterns and trends. It is also recognised that mask anxiety prevalence in the current study has been determined using a modified mask anxiety DT measure in the absence of an existing validated tool. The interview process was offered at participant convenience, both in timing (i.e. pre-treatment or during week 1) and delivery (i.e. face-to-face or phone, and with a carer present if requested by the participant), reducing the consistency of obtaining information. This variability in interview method allowed all participants access to accrual, and as such supported participant's involvement. The duration of interviews greatly varied, however, the interpretative descriptive model encourages all information to be accounted and included, regardless of content, so for this reason, all interviews were included, which supported the theme that a number of participants had concurrent stressors, which also need to be met to effectively support the person with HNC.
With close to one-third of all people with HNC potentially having a negative experience of mask anxiety, screening for, and providing assessment/intervention should be considered as a standard care in this population. The current study serves to increase the awareness of specialists in the delivery of RT that mask anxiety is common and has broad-ranging emotional and practical impacts. Further studies should seek to investigate the longitudinal patterns of mask anxiety during the course of RT treatment and explore patient perceptions of effective intervention.

Conclusions
This study found that up to 26% of patients potentially experience mask anxiety. Treatment strategies that were proposed by participants to manage the mask anxiety consisted of a combination of psychosocial support, education from the treating staff and reassurance to the patient that the experience of mask anxiety is a normal response to being immobilised. These interventions require further research to determine their effectiveness, in supporting this group of people who experience mask anxiety while undergoing treatment for HNC.