Advance Directives in Patients With Head and Neck Cancer - Status Quo and Factors Influencing Their Creation

doi:10.21203/rs.3.rs-689980/v1

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Advance Directives in Patients With Head and Neck Cancer - Status Quo and Factors Influencing Their Creation

https://doi.org/10.21203/rs.3.rs-689980/v1

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published 08 Apr, 2022

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Background:

Advance Care Planning (ACP) including living wills (LWs) and durable powers of attorney for healthcare (DPAHCs) is a highly relevant topic aiming to increase patient autonomy and reduce medical overtreatment. Data from patients with head and neck cancer are not currently available.

Methods:

In this single center cross-sectional study, we evaluated patients during their regular follow-up consultations at Germany’s largest tertiary referral center for head and neck cancer, regarding the frequency, characteristics, and influencing factors for the creation of advance directives (ADs) using a validated questionnaire tailored to our cohort. The advance directives included living wills, durable powers of attorney for healthcare, and combined documents (CDs).

Results:

Four hundred and forty-six patients were surveyed from 07/01/2019 to 12/31/2019 (response rate=65.9%). The mean age was 62.4 years (SD 11.9), 26.9% were women (n=120). 46.4% of patients (n=207) reported having authored at least one advance directive. These documents included 16 durable powers of attorney for healthcare (3.6%), 75 living wills (16.8%), and 116 combined documents (26.0%). In multinominal regression analysis, older age (OR≤0.231, 95% CI 0.097-0.548; p<0.001), regular medication (OR=1.862, 95% CI 1.048-3.308; p=0.034), and the marital status (“married”: OR=2.395, 95% CI 1.074-5.337; p=0.033; and “permanent partnership”: OR=4.526, 95% CI 1.100-18.625; p=0.036) emerged as significant factors increasing the likelihood of having an advance directive. In contrast, the stage of disease, the therapeutic regimen, the ECOG status, and the time from initial diagnosis did not correlate with the presence of any type of advance directive.

Conclusion:

Less than half of head and neck cancer patients had created an advance directive. Older and comorbid patients who were married or in a permanent partnership had a higher likelihood of having an advance directive. This is the first study investigating the current situation in head and neck oncology and providing evidence to identify a patient population in need of appropriate support.

Cancer Biology

Head & Neck Surgery

Advance Care Planning

Advance Directive

Head and Neck Cancer

Living Will

Patient Autonomy

Power of Attorney for Healthcare

The incidence of head and neck cancer is continuously increasing and now ranks seventh among all newly diagnosed malignancies worldwide [1]. The 5-year survival rate has long remained unchanged at between only 40% and 50% [2]. Compared with other solid tumor types, malignant head and neck cancers are often associated with crises during the course of disease. Complications such as dyspnea or tumor hemorrhage, but also therapeutic measures such as tracheostomy, are often accompanied by temporary or permanent restriction of the ability to consent and communicate, the proportion of older, multimorbid patients with head and neck cancer is increasing, leading to an even higher risk of life-threatening complications [3]. This aspect should be considered and included in head and neck oncology treatment planning [4, 5].

Next to the medical indication, the patient’s wishes are the primary factors protecting patient autonomy for any medical intervention. In the event that patients lose the ability to consent, they can state their preferences for certain future medical conditions in a living will (LW) [6, 7]. With a durable power of attorney for healthcare (DPAHC), patients can authorize a trusted person to represent their probable wishes by proxy. Combined documents (CDs) are considered useful and desirable [8]. They can ensure that the patient’s wishes are implemented, if necessary, even against any resistance to the contents of the LW.

The number of LWs in Germany has risen significantly in recent years, especially after changes in the law on advanced directives [Drittes Gesetz zur Änderung des Betreuungsrechts] in 2009 [9, 10]. The aim was to create a secure legal framework for documenting the patient’s wishes [11]. According to a survey of the German Hospice and Palliative Care Association, the proportion of people possessing an LW/DPAHC has increased from 26–43% since 2012 [12]. There is also a substantially growing need for professional counseling and support in creating and writing an LW/DPAHC. In 2017, the German Foundation for Patient Protection reported the highest level of counseling to date, with an increase of 13% over the previous year [9].

Data on the frequency of ADs (0–51%) vary widely in international comparisons and in relation to different patient populations [13–17]. Studies specifically on cancer patients showed LW prevalences of between 15% and 41% [17–20]. Data from clinical practice in head and neck cancer patients are not currently available.

The main objective of this study was to survey the frequency of an LW/DPAHC/CD in patients with head and neck cancer. Further objectives included the identification of relevant clinical and sociodemographic factors influencing the creation and availability of ADs. The topic is highly relevant and will increasingly confront medical staff because the demand and interest in LWs/DPAHCs will grow due to demographic changes and the rising incidence of head and neck cancer. Our findings should also serve as a basis to systematically increase the frequency and applicability of ADs and thus optimize the care of head and neck cancer patients.

In this prospective single center study, patients were asked about their ADs during the regular cancer follow-up visits at Germany’s largest tertiary referral center for head and neck cancer at the Department of Otorhinolaryngology, Head and Neck Surgery, Erlangen University Hospital, between July 1, 2019 and December 31, 2019. The study was conducted according to the Declaration of Helsinki, approved by the Ethics Committee of the University of Erlangen (No.: 76_19 B), and was registered in the German Registry for Clinical Studies (DRKS) (application No.: 00017123; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017123).

An advance directive was defined as a living will, a durable power of attorney for healthcare, or a document combining the two (CD).

Inclusion criteria for participation were as follows: former or current diagnosis of head and neck cancer of any tumor stage according to the Union international contre le cancer (UICC) classification, age ≥ 18 years, sufficient cognitive and language skills to answer the questionnaire independently, and the availability of complete medical records. All patients gave their written informed consent to participate. The following exclusion criteria were applied: lack of a diagnosis of head and neck cancer, cognitive impairment, or refusal to participate in the study.

During the study period when all eligible patients showed up for their regular follow-up, 30 patients per week were randomly selected to participate. Patients were asked to fill out a standardized and validated two-sided questionnaire according to de Heer et al. [15]. However, question #4 (“Mode of admission?”) was removed because it was irrelevant to the present study (see Supplement 1). In the questionnaire, patients were asked whether they possessed an LW and/or DPAHC and, if so, about their motivation to create the corresponding document, the time at which they had created it, the form that they had used, and whether they had received any support in writing it. Patients were also asked about their personal data, occupational background, family status, living environment, religion, medical history, and medication.

In addition to the questionnaire, oncologic characteristics (e.g., tumor location, UICC stage, and Eastern Cooperative Oncology Group [ECOG] status) were obtained from the patient’s medical records. Table 1 shows all the criteria considered. We divided the patients into five age groups. Pre-existing comorbidities were classified according to medical disciplines (cardiovascular, pulmonary, neurologic, oncologic). Tumors were staged using the 8th edition of the Tumor Node Metastasis (TNM) and the UICC classifications [21].

Table 1

Patient characteristics
Variable	N (n_total = 446)	%
Male Gender	326	73,1
Age in Years (mean ± SD)	62,4 ± 11,9
≤ 30	6	1,3
31–45	22	4,9
46–65	243	54,5
66–75	109	24,4
> 75	66	14,8
Marital Status
Single	55	12,6
Married	298	68,3
Permanent Partnership	13	3,0
Divorced	35	8,0
Widowed	35	8,0
Comorbidities
None	95	21,0
At least one Comorbidity	351	79,0
Cardiovascular Comorbidity	176	39,6
Pulmonal Comorbidity	63	14,2
Neurological Comorbidity	47	10,6
Oncological Comorbidity	99	22,3
Regular Medication (yes)	287	64,3
Living Environment
Independent at Home	357	86,9
At home with Support	49	11,9
Care Facility	5	1,2
Cancer Localization
Oropharynx	110	24,7
Larynx	95	21,3
Salivary Glands	61	13,7
Cutaneous cancer of the Head and Neck	44	9,9
Oral Cavity	36	8,1
Inner Nose	28	6,3
Hypopharynx	21	4,7
Multi-tier Carcinoma	16	3,6
Cancer of Unknown Primary (CUP-Syndrome)	14	3,1
Lymphoma in the Head and Neck	11	2,5
Nasopharynx	6	1,3
Thyroid Gland	3	0,7
Lips	1	0,2
Secondary Malignancies¹
No	360	83,3
Yes, synchronous	18	4,2
Yes, metachronous	54	12,5
Recurrence of Cancer	437	%
No	395	90,4
Loco-regional Recurrence	39	8,9
Distant Metastases	3	0,7
UICC-Stadium
0	6	1,6
I	132	34,3
II	67	17,4
III	61	15,8
IV	119	30,9
ECOG Performance Status	386
0	289	74,9
1	74	19,2
2	21	5,4
3	2	0,5
Applied Therapy
Surgery	171	38,3
Primary Surgery plus Adjuvant Therapy	71	15,9
Definitive Radiochemotherapy	198	44,4
Salvage Surgery	6	1,3
¹ also outside the Nead and Neck Area

At the time of the survey, we retrospectively documented treatment modality (surgical treatment, primary surgical treatment with adjuvant therapy, definitive radiochemotherapy, salvage surgery), the presence of synchronous or metachronous secondary cancer, the time from initial diagnosis to survey period and/or locoregional or distant metastases, and the current ECOG status [22] from the patient’s records. The frequency of ADs in our study population was defined as the primary endpoint. Secondary endpoints comprised clinical and sociodemographic factors influencing the creation of an appropriate document.

Statistical Analysis

Categorical variables were reported as absolute frequencies (n) with percentages (%) and continuous variables as mean (M) with standard deviation (SD). To identify significant differences between the presence of ADs within clinical and sociodemographic factors, all factors were pretested using univariate logistic regression. The relevant demographic and clinical variables identified in this way were analyzed for their influence on the presence of ADs using multinomial logistic regression. The age group over 75 years served as a reference category, since it is known from the literature that the presence of ADs in other patient populations is associated with a higher age [15, 17, 18, 23]. For marital status, we chose “single” as the reference. For pre-existing comorbidities, medication, and employment, we selected “yes” as the reference answer. Only those data sets were considered in which values were available for all the variables concerned (“listwise deletion of missing cases”). This corresponded to 369 cases, i.e., about 17.3% of the cases were missing in the multinominal approach. Results with a p-value of ≤ 0.05 were considered significant and marked with an asterisk (*). All analyses were performed using SPSS Statistics version 27.0 software (IBM, New York, USA).

During the study period, 30 questionnaires were randomly distributed each week (n = 775) and 534 questionnaires were returned, resulting in a response rate of 68.9%. Out of these, 446 patients met the inclusion criteria (83.5%) and were included in the following analysis.

Patient Characteristics

Table (1) presents the characteristics of all patients included. Among the 446 patients (mean age 62.4 years, SD 11.9), 120 were women (26.9%; mean age 61.5 years, SD 13.5) and 326 were men (73.1%; mean age 62.8 years, SD 11.2). Only 12.6% of patients were single, while the majority were currently or had been in a partnership. Two-thirds of them were married (68.3%; n = 298) or living in a permanent partnership (3.0%; n = 13). 70 patients were either widowed (8.0%; n = 35) or divorced (8.0%; n = 35). 357 patients (86.9%) lived independently at home, and only a minority were living in a care facility (1.2%; n = 5) or at home with support (11.9%; n = 49). Most patients (79%; n = 351) had at least one comorbidity and had to take medication on a regular basis (64.3%; n = 287). 46.7% of patients had a UICC stage III or higher and the most frequent cancer sites were the oropharynx (24.7%; n = 110) and the larynx (21.3%; n = 95). The mean time since diagnosis was 45.6 months (SD 44.5; median = 32). Eighteen patients (4.2%) were diagnosed with synchronous and 54 patients (12.5%) with metachronous secondary malignancies. 38.3% of patients had undergone surgical treatment alone, while another 44.4% had received additional adjuvant therapy, i.e., radiotherapy (RT) or radiochemotherapy (RCT). Primary definitive concurrent radiochemotherapy (pRCT) was given in 15.9% of cases. Only 1.3% underwent salvage surgery. A locoregional recurrence of cancer occurred in 39 cases (8.9%) and distant metastasis in 3 cases (0.7%). The mean interval between initial diagnosis and survey period was 45.6 months (SD 44.5). 94% of patients surveyed had an ECOG status of 0 or 1.

Frequency and factors influencing the presence of ADs

Out of the 446 patients included, 207 patients (46.4%) had at least one AD. These included 16 patients with a DPAHC (3.6%), 75 patients (16.8%) with an LW, and 116 patients with a CD (26.0%). Thirty-five patients (7.8%) did not know whether they had an AD, while 204 patients (45.7%) certainly did not have one. Considering DPAHCs and LWs separately – since CDs always contain both – DPAHCs existed in 29.6% (n = 132) and LWs in 42.8% (n = 181) of the cases. The results are shown in Figures (1) and (2).

Univariate analysis revealed six significant predictors (including age, marital status, and pre-existing comorbidities) with a significantly higher likelihood of having at least one AD. As age increased, so did the likelihood of having an AD. No patient younger than or equal to 30 years had any AD at all. Patients between 31 and 45 years of age were 18.2 times less likely to have ADs than patients over 75 (odds ratio [OR] = 0.055, 95% confidence interval [95% CI] 0.014–0.213; p < 0.001). Compared with patients over 75 years of age, patients aged 46–65 years and 66–75 years were 4.2 times (OR = 0.236, 95% CI 0.124–0.448; p < 0.001) and 2.5 times (OR = 0.407, 95% CI 0.204–0.812; p = 0.011) less likely to have ADs, respectively. Patients who were still working were 1.8 times less likely to have an AD than those who were retired (OR = 0.549, 95% CI 0.371–0.814; p = 0.003).

Family status also had an impact on the existence of ADs, as patients living in a partnership had significantly more ADs than those living alone. Married patients were 4.2 times more likely to have an AD than singles (OR = 4.221, 95% CI 2.099–8.488; p < 0.001). Patients living in a permanent partnership were also significantly more likely to have an AD compared with single patients (OR = 6.400, 95% CI 1.748–23.438; p = 0.005). Divorced (OR = 3.000, 95% CI 1.171–7.684; p = 0.022) and widowed patients (OR = 3.778, 95% CI 1.482–9.631; p = 0.005) also had ADs more often than singles.

Patients with “at least one current comorbidity” (OR = 2.136, 95% CI 1.319–3.461; p = 0.002) or a “cardiovascular comorbidity” (OR = 1.572, 95% CI 1.072–2.306; p = 0.020) were significantly more likely to have ADs. Patients on “regular medication” (OR = 2.372, 95% CI 1.501–3.750; p < 0.001) had created ADs significantly more often.

In the multinomial approach, the factors “regular medication” (OR = 1.862, 95% CI 1.048–3.308; p = 0.034), “marital status” (“married”: OR = 2.395, 95% CI 1.074–5.337; p = 0.033 or “permanent partnership”: OR = 4.526, 95% CI 1.100-18.625; p = 0.036) and “higher age” correlated significantly with the presence of an AD. The older the patient, the more likely they were to have an advance directive. Accordingly, the chances of a patient over 75 years of age having an AD were higher than for a patient aged between 31 and 45 (OR = 0.047, 95% CI 0.008–0.265; p < 0.001), 46 and 65 (OR = 0.193, 95% CI 0.081–0.457; p < 0.001), or over 65-year-olds (OR = 0.231, 95% CI 0.097–0.548; p < 0.001). Table 2 shows the results of univariate and multinominal regression analyses.

Table 2

Factors influencing Advance Directives - Logistic Regression Analysis
Variable	Univariate			Multinominal
Variable	OR	95% CI	Result of statistical Analysis (p-Value)	OR	95% CI	Result of statistical Analysis (p-Value)
Age Group (> 75)
≤ 30	0.000	[0.000–0.000]	0.999	0.000	[0.000–0.000]	.
31–45*	0.055	[0.014–0.213]	< 0.001*	0.047	[0.008–0.265]	< 0.001*
46–65*	0.236	[0.124–0.448]	< 0.001*	0.193	[0.081–0.457]	< 0.001*
66–75*	0.407	[0.204–0.812]	0.011*	0.231	[0.097–0.548]	< 0.001*
Marital Status (Single)
Married*	4.221	[2.099–8.488]	< 0.001*	2.395	[1.074–5.337]	0.033*
Divorced*	3.000	[1.171–7.684]	0.022*	2.252	[0.760–6.674]	0.134
Widowed*	3.778	[1.482–9.631]	0.005*	1.516	[0.489–4.703]	0.471
Permanent partnership*	6.400	[1.748–23.438]	0.005*	4.526	[1.100-18.625]	0.036*
At least one comorbidity (yes)	2.136	[1.319–3.461]	0.002*	1.601	[0.847–3.025]	0.147
Cardiovascular comorbidity (yes)	1.572	[1.072–2.306]	0.020*	0.857	[0.512–1.435]	0.558
Regular medication (yes)*	2.372	[1.501–3.750]	< 0.001*	1.862	[1.048–3.308]	0.034*
Employment at the time of survey (yes)	0.549	[0.371–0.814]	0.003*	0.935	[0.554–1.578]	0.801
• Reference Categories: Age Group (> 75 years), Marital Status (Single), At least one Comorbidity (yes), Cardiovascular Comorbidity (yes), Regular medication (yes), Employment (yes). • Rows marked with an asterisk (*) indicate the influencing factors that were found to be statistically relevant. • Lines marked in bold indicate the influential factors that had proved to be statistically relevant in both univariate and multinominal analyses. • N = number of patients; OR = odds ratio; 95% CI = 95% confidence interval; p = Value of Significance;
Model goodness of fit: -2 Log-likelihood: 172.052; Cox & Snell: 0.153; Nagelkerke: 0.205; McFadden: 0.120

Our survey shows that less than half of the head and neck cancer patients studied had created an AD. DPAHCs alone were present in only 3.6% of these patients, LWs alone in 16.8% and CDs in 26.0%. The presence of a comorbidity or regular medication increased the chances of having an AD twofold in each case, whereas the severity of the head and neck cancer or another cancer diagnosis did not play a relevant role. As the age of the patients increased, so did the prevalence of ADs in our cohort. In addition, the social situation played a decisive role, because married patients and patients living in a permanent relationship were four times more likely to have an AD than single patients.

The frequencies of ADs described in the literature vary widely and show large regional and interdisciplinary differences. In studies of non-cancer patients from the United States, 7% of patients admitted for acute cerebral hemorrhage had an appropriate document [14]. In Japan, 44% of patients with various cancers reported having an AD [19]. Kirkpatrick et al. compared 112 cardiology patients with cancer patients from the same hospital and found no significant differences in the frequency of LWs [16]. In a study of 753 cancer patients from China, not a single patient had an AD [17]. Of 75 American patients referred to an oncology center for therapy, 44% had an LW [20]. Another study showed that only 15% of critically ill patients with non-resectable pancreatic cancer had an LW [18].

In Germany, the situation is similarly variable. A retrospective study of intensive care patients found that out of 658 patients who died, 12% had an LW. Among the deceased, 105 were tumor patients. A DPAHC was present in only 8% of cases [24]. In 2009, a study on surgical patients showed that LWs existed in 16.7% of cases. Compared with 2004, however, the authors found that the number of written LWs possessed by critically ill cancer patients had significantly increased from 11% and 8.5% in two large university hospitals [25]. In a survey of 503 patients from a haemato-oncology outpatient clinic, the prevalence of LWs was 31% in 2011/2012. More than half of the documents were written after 2009, i.e., after changes had been made to the law on advance healthcare directives [26]. These changes led to an overall increase in the frequency of ADs in Germany, also evident from two representative surveys conducted by the German Hospice and Palliative Association in 2012 and 2017 that show a strong upward trend in available documents from 26–43% [12].

In a recent study from 2017, de Heer et al. reported that 51.3% patients in an interdisciplinary intensive care unit possessed ADs [15]. Within the entire patient collective 41.3% were cancer patients. None of the above studies specifically addressed head and neck cancer patients, so there is no robust evidence on the situation in head and neck oncology to date.

The results presented here show that the frequency of 46.4% for ADs in head and neck cancer patients is comparable to international and interdisciplinary figures. Using multinomial regression analysis, we demonstrated “marital status”, “regular medication”, and “increasing age” to be influential factors for ADs in head and neck cancer patients.

Zheng et al. investigated factors influencing the preparation of ADs in cancer patients, including 23.2% with head and neck cancer. Increasing age, female gender, higher education level, religious affiliation, and higher ECOG status turned out to be significant variables in univariate analysis [15, 17, 18, 23]. While age was a significant factor in our analysis, the other variables were not found to determine the presence of an AD, which may be attributed to differences in the patient populations studied.

Tan et al. also demonstrated increasing age and, contrary to our findings, unmarried marital status as relevant factors influencing the prevalence of ADs in patients with non-resectable pancreatic cancer. In addition, patients who had previously received anticancer therapy had more frequently created ADs [18]. The association between increasing age and the presence of ADs was also shown in a study of veterans without underlying malignancy from a rural area in Alabama and another study of patients with haemato-oncologic disease. Mahaney-Price et al. found religiosity to be a relevant influencing factor in addition to the influence of age [27]. In contrast, religiosity or a specific religion had no significant effect on the decision to create ADs in our patient population.

Given that the survey was conducted in the outpatient setting, data from patients whose general condition did not allow them to attend for follow-up are inevitably missing, and the results presented here should be interpreted accordingly. Data were also missing from patients who did not attend after completion of the 5-year follow-up period. Furthermore, the study setting means that the prevalence of patients with locoregional recurrence and distant metastatic cancer is somewhat reduced. On the other hand, the number of patients from one of Germany’s leading head and neck cancer centers represents the largest cohort studied in this field to date. It covers the entire spectrum of head and neck cancer, allowing for a representative and meaningful analysis.

Regarding the practicality of ADs in everyday practice, it is important to note that our results are based on patient data from the questionnaires. The actual availability and applicability of ADs were beyond the scope of this study. In this context, de Heer et al. were able to show that there was a large discrepancy between the information given by the patient and the actual availability of the AD, as less than one third of the documents had been handed in at the clinic [15]. The existence of ADs in physical and electronic patient records, combined with their quality (e.g., form of the document, timing and support in drafting, signature, and applicability: situation description, desired actions, etc.), are subjects for future investigation.

Further research on this topic is therefore desirable, both to raise awareness of this important issue among treating clinicians through evidence-based data and to assist head and neck cancer patients in creating ADs and improving their availability and applicability in clinical practice. Our data offer the potential to identify patients who need additional attention in this regard.

The results show that less than half of head and neck cancer patients have an AD: similar to patients with other cancers, they are mainly older patients with comorbidities living in a regulated social setting. Given the increasing incidence of head and neck cancer, a higher rate of ADs is desirable. Our findings highlight the current situation in head and neck oncology and provide a basis for future meaningful efforts to identify critical patients in order to increase the frequency and applicability of advance directives.

• Ethics approval and consent to participate: The Ethics Committee of the University of

Erlangen-Nuremberg has approved the presented work (approval number: 76_19 B).

The need for informed consent was waived off by the Ethics Committee of the Friedrich-

Alexander University of Erlangen-Nuremberg, because this was a retrospective study.

This study was carried out according to the Declaration of Helsinki (in accordance with the

relevant guidelines and regulations).

• Consent for publication: Not applicable.

• Availability of data and materials: The datasets used and/or analysed during the current study

available from the corresponding author on reasonable request.

• Competing interests: Not applicable.

• Funding: Not applicable.

• Authors' contributions:

Moritz Allner: conception and design, acquisition of data, analysis and interpretation of data, wrote the main manuscript, final approval of the version to be published.
Magdalena Gostian: conception and design, analysis and interpretation of data, final approval of the version to be published.
Matthias Balk: critical revision of the article.
Robin Rupp: critical revision of the article.
Clarissa Allner: critical revision of the article.
Konstantin Mantsopoulos: critical revision of the article.
Christoph Ostgathe: critical revision of the article, final approval of the version to be published.
Heinrich Iro: critical revision of the article, final approval of the version to be published.
Markus Hecht: acquisition of data, critical revision of the article, final approval of the version to be published.
Antoniu-Oreste Gostian: conception and design, acquisition of data, analysis and interpretation of data, drafting and critical revision of the article, final approval of the version to be published.

• Acknowledgements: None.

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No competing interests reported.

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Advance Directives in Patients With Head and Neck Cancer - Status Quo and Factors Influencing Their Creation

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Patient Characteristics

Frequency and factors influencing the presence of ADs

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