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How Do Head and Neck Cancer Patients Prioritize Treatment Outcomes Before Initiating Treatment?

From the Departments of Medicine and Radiation and Cellular Oncology, and the Cancer Research Center, University of Chicago; Chicago Oral Cancer Center; Lurie Cancer Center Biostatistics Section, Health Services Research and Policy Studies, and Northwestern University Medical School, Northwestern University, Chicago, IL; and University of Miami, Miami, FL.

Address reprint requests to Marcy A. List, PhD, Associate Director, Cancer Control and Community Research, University of Chicago Cancer Research Center, 5841 S Maryland MC 1140, Chicago, IL 60637; email mlist{at}medicine.bsd.uchicago.edu

	ABSTRACT

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PURPOSE: To determine, pretreatment, how head and neck cancer (HNC) patients prioritize potential treatment effects in relationship to each other and to survival and to ascertain whether patients’ preferences are related to demographic or disease characteristics, performance status, or quality of life (QOL).

PATIENTS AND METHODS: One hundred thirty-one patients were assessed pretreatment using standardized measures of QOL (Functional Assessment of Cancer Therapy-Head and Neck) and performance (Performance Status Scale for Head and Neck Cancer). Patients were also asked to rank a series of 12 potential HNC treatment effects.

RESULTS: Being cured was ranked top priority by 75% of patients; another 18% ranked it second or third. Living as long as possible and having no pain were placed in the top three by 56% and 35% of patients, respectively. Items that were ranked in the top three by 10% to 24% of patients included those related to energy, swallowing, voice, and appearance. Items related to chewing, being understood, tasting, and dry mouth were placed in the top three by less than 10% of patients. Excluding the top three rankings, there was considerable variability in ratings. Rankings were generally unrelated to patient or disease characteristics, with the exception that cure and living were of slightly lower priority and pain of higher priority to older patients compared with younger patients.

CONCLUSION: The data suggest that, at least pretreatment, survival is of primary importance to patients, supporting the development of aggressive treatment strategies. In addition, results highlight individual variability and warn against making assumptions about patients’ attitudes vis-à-vis potential outcomes. Whether patients’ priorities will change as they experience late effects is currently under investigation.

	INTRODUCTION

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OVER THE PAST two decades there has been a growing and sustained interest in quality of life (QOL) and functional outcomes as secondary end points in head and neck cancer (HNC) treatment. Numerous disease specific assessment instruments have been developed and validated, and treatment toxicities and late effects have been described. Over the same time period, in an effort to improve survival and QOL, investigators have explored various combinations of chemotherapy and radiation therapy as alternatives to aggressive surgical resection. As a result, many HNC patients now have access to a broader range of treatment options that may differ in terms of survival, acute morbidity, organ preservation, and severity and nature of long-term symptoms or impairments. How patients prioritize these considerations is not known. For example, if presented with the choice, would patients value increased chances of speech preservation over swallowing? How important is survival relative to potential long-term impairment?

The few studies exploring these issues raise additional questions. For example, in a frequently quoted study from the early 1980s, ¹ approximately 20% of a sample of healthy volunteers indicated that, if diagnosed with laryngeal cancer, they would choose radiation rather than surgery. Radiation was described as resulting in lower rates of 5-year survival but preserving normal or near normal speech. Whether actual patients would choose similarly is unknown. In a more recent study examining perceptions of postlaryngectomy late effects, patients’ views differed from those of their health care providers. Patients ranked the physical consequences of surgery (eg, tracheal mucous production) and interference with social activities as the QOL dimensions most important to them. In contrast, providers ranked impaired communication and self-esteem as the two dimensions they believed were most significant.²

QOL studies describe patients’ sense of the nature and severity of late effects. Most QOL instruments, however, do not include assessment of the relative importance of these outcomes or QOL dimensions. Rather, they consist of multiple items summarized into subscales, each of which represents functioning in a specific QOL domain, such as emotional or physical well-being (eg, Functional Assessment of Cancer Therapy-General),³ or more specific HNC domains, such as appearance or swallowing (eg, University of Washington QOL scale).⁴ Although clearly informative in describing outcomes and comparing treatment arms, these data provide no indication of the value that patients place on specific domains or, alternatively, the negative appraisal attached to specific impairments. Furthermore, although limited, available data suggest that providers’ assumptions may not reflect patients’ attitudes.^5,2 Given the current climate of treatment development and treatment choice, understanding what is important to patients is essential. In addition to informing treatment advances, such data might help to direct QOL research and focus on the areas most important to patients.

The current study examined patients’ pretreatment priorities concerning potential treatment effects. It focused on patients with newly diagnosed stages II to IV HNC, a group who, in addition to the acute effects of treatment, will likely face residual impairments and problems, regardless of treatment modality. These late effects are well-documented and include voice loss or change in voice quality; disfigurement; skin irritation; dry mouth; pain; sticky saliva; fatigue; and difficulty chewing, swallowing, and tasting.^6-16 The aim was to determine how patients prioritize these potential consequences in relationship to each other as well as in relation to survival. A second goal was to ascertain whether patients’ preferences were related to individual demographic characteristics, performance or functional status, or patients’ QOL.

	PATIENTS AND METHODS

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Eligibility
Participants were drawn from the following nine institutions: University of Chicago, Northwestern University, and Weiss Hospital (Chicago, IL); University of Miami, Miami Veteran’s Affairs (Miami), and H. Lee Moffit Cancer Center (Tampa, FL); University of Tennessee at Memphis (Memphis, TN); Zablocki Veteran’s Affairs Medical Center (Milwaukee, WI); and University of Pittsburgh (Pittsburgh, PA). Eligibility included newly diagnosed, stage II to IV HNC (larynx, oral cavity, oropharynx, pharynx, and nasopharynx); no prior chemotherapy or radiotherapy; and treatment that must include primary surgery ± radiation or primary chemoradiotherapy. A contact physician served as the principal investigator at each institution. This individual was responsible for obtaining institutional human subjects approval and, working with the designated speech language pathologist, identifying eligible patients. It was determined that, given medical centers’ procedures, accessing patients after definitive diagnosis but before treatment decisions would be difficult. To ensure consistency across patients, it was required that staging be complete and a treatment plan established before patient registration and assessment.

Assessment Procedures
Each institution named a project coordinator/interviewer (PC) and all PCs attended a training session in Chicago. After informed consent had been obtained, the PC administered forms and interviewed patients in the outpatient clinic or hospital room. Self-administered forms were given to the patients to complete with the PC’s assistance as needed. Disease and treatment data were retrieved from patients’ medical charts and protocol records. Patients were assessed before treatment (either surgery or chemoradiotherapy) and at 3, 6, and 12 months after treatment. This paper presents pretreatment data only.

Assessment included the Performance Status Scale for Head and Neck Cancer (PSS-HN)¹⁷ and the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N). The PSS-HN is a clinician-rated instrument consisting of three subscales: normalcy of diet, eating in public, and understandability of speech. Scales are scored from 0 to 100, with higher scores representing better performance, defined as better day-to-day functioning in the specified area. The PSS-HN has been demonstrated to be reliable and valid in head and neck cancer patients.^17,18

The FACT-H&N^3,19 is a multidimensional, self-report QOL instrument specifically designed for use with cancer patients. The core scale (FACT-General) consists of 33 items to which disease-specific extensions are added; the version three head and neck module used here consists of 11 items. The measure assesses patient satisfaction and functioning in six areas: physical well-being, social well-being, relationship with doctor, emotional well-being, functional well-being, and head and neck concerns. Higher scores represent better QOL. The FACT is one of a select number of QOL instruments in cancer patients that has extensive reliability and validity data as well as careful attention to test construction and evaluation. Test-retest correlation coefficients for subscales and total score ranged from 0.82 to 0.92, and the scale proved sensitive to group differences based on stage of disease, performance status, and change in performance status. In addition, FACT-H&N subscales and total score have been demonstrated as valid and sensitive to HNC-patient groups on the basis of treatment status, global performance status as measured by the Karnofsky performance status,¹⁸ and observed changes over time.¹¹

Assessment of Patients’ Priorities
This task involves the rank ordering of potential disease and treatment effects. Patients are presented with a magnetic board and 12 positively phrased statements printed on magnetic index-like cards. They are asked to arrange the cards on the board into three categories: highest priority, medium priority, and lower priority. Patients are then instructed to rank order statements within each category. The interviewer records the order of statements assigning numbers 1 to 12, with 1 representing the top priority and 12 the lowest. Cards present the following statements: (1) keeping my natural voice; (2) being able to chew normally; (3) being able to swallow all foods and liquids; (4) being cured of my cancer; (5) having no pain; (6) keeping my appearance unchanged; (7) returning to my regular activities as soon as possible; (8) having a normal amount of energy for me; (9) keeping my normal sense of taste and smell; (10) being understood easily; (11) living as long as possible; and (12) having a comfortably moist mouth.

As described in detail elsewhere, these items were devised and selected with input from HNC patients and their health care providers. To maximize inclusion of all items that might be important to patients, instrument development included HNC patients of all disease sites, treatment modalities, and stages of treatment and recovery. In addition, scale items were validated with regard to content through the use of semi-structured interviews with HNC patients. Further pilot testing demonstrated the task to be feasible and provided evidence for test-retest reliability of rankings in HNC patients with stable conditions.²⁰

Statistical Methods
Patient and disease characteristics are presented using percentages, medians, and ranges. Performance status (PSS-HN) was summarized by the percentage of patients scoring above (or below) 50, with scores 50 generally indicative of moderate to severe dysfunction.¹⁸ Because there are no standard or easily interpretable cutoff scores for the FACT, these data are reported in terms of means and SDs.

Priority rankings were summarized by calculating the percentage of patients placing an item among the top three priorities, ie, assigning it 1, 2, or 3. Calculations were performed separately for each item. Mean rankings and SDs were also calculated for use in correlational analyses.

Spearman rank correlation coefficients (using individual scores), ² tests (using scores categorized by cutoffs), and analysis of variance were applied to examine the relationship between preferences (ie, priority rankings) and patient characteristics, disease variables, performance status, and QOL.

	RESULTS

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Patient Characteristics
A total of 137 patients were enrolled onto the study. Six had invalid or missing priority scale scores and were, therefore, excluded from the analyses. The final study sample of 131 patients included 87 men and 44 women. Median age was 59 years (range, 29 to 87 years). Eighty-one percent of patients had at least a high school education, 56% were married, 37% had incomes less than $20,000, and 31% reported that they were working at least part-time at the time of interview, with an additional 33% retired. The majority of patients (70%) had locoregionally advanced (stage IV) disease. For two thirds of the sample, some form of combined chemoradiotherapy was to be the primary treatment approach. Patients represented a range of disease sites, with oropharynx (35%), larynx (27%), and oral cavity (17%) the three most frequent sites. Patient and disease characteristics are listed in Table 1.

Priority Rankings
Table 2 lists patients’ rankings of priority scale items. Column 1 presents the percentage (and number) of patients who placed the item among their top three priorities. Column 2 presents the percentage (and number) of patients who ranked the item as their top priority. Column 3 presents mean rankings for each item, with 1 representing top priority and 12 representing lowest priority.

Variability in Patient Preferences
Although some items were consistently ranked high or low, as presented in Fig 1, there was an enormous amount of variability in how patients ranked individual items. For each item shown on the x-axis, the portion of circle above represents the percentage of patients giving that item the corresponding rank on the y-axis. For example, a three-quarter circle illustrates that approximately 75% of patients ranked being cured of my cancer as number 1 priority. Another 14% (< one-sixth circle) ranked it number 2 in importance, and the remaining 11% were scattered across different levels, illustrated by the individual lines. On the other hand, for keeping my natural voice, there were similar numbers of patients placing it at each level of importance.

View larger version (23K): [in this window] [in a new window]   Fig 1. Patients’ priority rankings by item.

Relationship Between Rankings and Performance Status and QOL
Overall, there was a suggestion that patients rank down (ie, assign less importance to) items related to areas in which they are functioning relatively well. For instance, patients with less restricted diets placed a lower priority on outcomes related to eating. More specifically, patients scoring above 50 on normalcy of diet compared with those scoring 50 were less likely to rank being able to swallow (14% v 39%, respectively; P = .002) and having no pain (31% v 50%, respectively; P = .06) in the top three and more likely to rank normal energy (28% v 7%, respectively; P = .02) in the top three. Similarly, higher scores on the diet scale (better functioning) were positively and statistically significantly correlated with swallow (r = .22, P = .01), no pain (r = .23, P = .008), taste (r = .22, P = .01) and negatively correlated with energy (r = -.19, P = .03) and being understood (r = -.26, P = .003); higher scores on rankings indicate lower priority. There was virtually no relationship between scores on eating in public or understandability of speech and rankings of any of the 12 outcomes on the priority scale.

In terms of QOL dimensions, there was a tendency for patients with better QOL to place greater importance on being cured and having energy and less importance on having no pain. Higher scores on social well-being, relationship with doctor, and overall QOL (FACT-G) were significantly correlated with lower rank scores (higher priority) for being cured of cancer (r = -.19, P = .03; r = -.17, P = .06; and r = -.17, P = .06, respectively). Similarly, better social well-being and higher scores on head and neck subscale were related to placing higher priority on having energy (r = -.19, P = .03; and r = -.21, P = .02, respectively). Conversely, higher scores on physical, social, emotional, and functional well-being, head and neck subscale, and overall QOL were correlated with higher rank scores (lower priority) for having no pain (r = .23, P = .01; r = .26, P = .004; r = .20, P = .02; r = .26, P = .004; r = .19, P = .03; and r = .32, P < .001, respectively). Although the magnitude of these correlation coefficients is modest at best, the pattern and direction of correlations is consistent and suggests a pattern of association.

	DISCUSSION

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
Deciding among treatment options, weighing possible differences in immediate toxicity as well as late effects, and preparing for these potential outcomes is a complex task for both HNC patients and their health care providers. The growing availability of descriptive QOL data is valuable and provides for a better understanding of the impact of various treatment regimens on patients’ physical, functional, and psychosocial well-being. What is less clear, however, is how important specific sequelae are to patients and how patients evaluate one against the other or against survival.

The current study examined patients’ preferences pretreatment. A group of newly diagnosed, advanced-stage HNC patients were asked to prioritize, by rank ordering, a series of possible late effects of HNC treatment. The study was open to all eligible patients at multiple institutions across the United States, thus avoiding single-institution biases. Results indicated that, at least at this point in time, survival was of primary importance. Eighty-three percent of patients placed either being cured of my cancer (98 patients) or living as long as possible (11 patients) as their top priority, with an additional 10 patients placing cured as number 2.

These data are consistent with other reports in the literature suggesting that patients may be willing to accept rather severe acute toxicity as well as the possibility of chronic dysfunction for any chance of benefit. At the same time, however, there is some indication that health care providers may not fully appreciate this perspective. For example, in a study of attitudes toward chemotherapy, a group of newly diagnosed cancer patients, when presented with various scenarios, expressed the willingness to undergo extremely aggressive chemotherapy for the possibility of an extremely limited survival advantage. In contrast, nonpatients, oncology nurses, and oncologists were much less likely to opt for such treatment with the expectation of minimal gain.⁵ Analogously, data from studies of elderly patients found, that in contrast to the assumptions of their surrogate decision makers, the majority of the patients were not willing to give up survival time in their current health state for a shorter life in a better health state.²¹ The few studies of HNC patients interviewed after treatment similarly advise against presumptions about patients’ preferences. For instance, although 20% of one cohort of postlaryngectomy patients expressed the willingness to compromise anticipated life expectancy to preserve voice, almost half (46%) of their health care providers thought that their patients would make such a decision.²² These observations highlight the importance of ascertaining patients’ values and priorities. The fact that the majority of patients seem willing to accept a high degree of treatment toxicity to maximize life expectancy requires further confirmation and follow-up of patients over time.

Patients in this study were assessed before treatment initiation but after the treatment had been selected and the treatment plan established. Treatment decisions likely reflected some weighted combination of institutional policy, provider bias, and patient preference. The degree to which patient rankings were influenced by the timing of assessment (ie, treatment regimen already decided) is unknown. There was, however, little difference between patients whose primary treatment was to be surgery when compared with those for whom it was to be chemoradiotherapy.

Examinations of the nonmedical outcomes of HNC treatment have frequently focused on speech and swallowing, functions that are obviously affected. This emphasis may, in part, also reflect the biases of researchers and clinicians who believe these functions to be of priority to patients.^2,22 Disfigurement is similarly cited as one of the prominent negative sequelae of HNC treatment.^23,24,7 Current findings do not entirely support these suppositions. Items related to energy and normal activities were more often ranked among the top three priorities than were items related to appearance, chewing, and being understood, irrespective of anticipated treatment. Although these data reflect pretreatment preferences, a study of postlaryngectomy patients similarly found them to place greater importance on interference with social activities, whereas their providers believed impaired communication and self-esteem were most important.² At the same time, however, with the exception of the top three items, there was considerable variability in patients’ rankings. Whether this variability reflects real differences in preference or, alternatively, a real indifference among outcomes other than survival is being further explored. In addition, patients have not yet experienced the outcomes in question and, therefore, may not be able to evaluate them adequately.

A series of planned analyses examined the basic relationships between priority rankings and patient, disease, QOL, and functional parameters. Although representing a large number of comparisons, these planned analyses yielded a greater number of statistically significant results than would be expected by chance. Observed variability in ranking was not strongly attributable to, nor explained by, disease or most demographic characteristics. On the other hand, rankings were related to age, performance, and overall QOL.

Older patients were less likely to rank cured or living among their top three priorities. Because patients were not queried about the reasons for item placements, the feelings underlying these preferences remain unknown. The authors speculate that potential contributing factors might include feelings of already having lived a full life and/or experiences with elderly friends or relatives with progressive disability. Both of these situations might lead the older patient to place less value on living as long as possible and a somewhat higher value on comfort, as exemplified by the value placed on having no pain.

With respect to QOL and performance status, there was a trend for patients to place a higher priority on areas of functioning in which they were experiencing problems. For example, patients who had more restricted diets ranked swallowing significantly higher than those who had few restrictions. Similarly, patients who reported better QOL and fewer head and neck symptoms tended to place greater importance on cure and having energy and less on having no pain. At the time of interview, patients were functioning reasonably well overall. Whether one might observe stronger associations if greater numbers of patients were showing performance deficits is unknown.

The significance of study results is not to diminish the importance of collecting good QOL data or to understate the importance of minimizing long-term dysfunction. Rather, the data support the continued development of aggressive treatment strategies that maximize survival. In addition, they highlight the degree to which patients have differing priorities with respect to the functional outcomes of treatment. This paper reports on patients’ attitudes before beginning treatment when they had not experienced many of the items on the priority scale. Whether patients’ priorities and the value they place on specific functions will change with experience and degree of impairment is under investigation. The current cohort of patients is being observed for a 12-month period after treatment, with reassessment at 6 and 12 months. In addition, data on a group of non–cancer patients matched with the HNC group on demographics are being compiled and will be compared with the patients’ preferences.

	ACKNOWLEDGMENTS

 
Supported in part by National Cancer Institute Cancer Control Science Program grant no. PO1 CA-40007 and National Cancer Institute Oral Cancer Center "Carcinogenesis and Novel Therapeutics in Oral Cancer" grant no. DE/CA11921.

	REFERENCES

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
1. McNeil BJ, Weichselbaum R, Pauker SG: Speech and survival: Tradeoffs between quality and quantity of life in laryngeal cancer. N Engl J Med 305:982-987, 1982[Abstract]

2. Mohide EA, Archibald SD, Tew M, et al: Postlaryngectomy quality of life dimensions identified by patients and health care professionals. Am J Surg 164:619-622, 1992[Medline]

3. Cella DF, Tulsky DS, Gray G, et al: The functional assessment of cancer therapy scale: Development and validation of the general measure. J Clin Oncol 11:570-579, 1993[Abstract/Free Full Text]

4. Hassan SJ, Weymuller EA Jr: Assessment of quality of life in head and neck cancer patients. Head Neck 15:485-496, 1993[Medline]

5. Slevin ML, Stubbs L, Plant HJ: Attitudes to chemotherapy: Comparing views of patients with cancer with those of doctors, nurses, and general public. BMJ 300:1458-1460, 1990

6. de Andres L, Brunet J, Lopez Pousa A, et al: Function preservation in stage III squamous laryngeal carcinoma: results with an induction chemotherapy protocol. Laryngoscope 10:822-826, 1995

7. De Boer MF, Pruyn JFA, van den Borne B, et al: Rehabilitation outcomes of long-term survivors treated for head and neck cancer. Head Neck 17:503-515, 1995[Medline]

8. Harrison LB, Zelefsky MJ, Pfister DG, et al: Detailed quality of life assessment in patients treated with primary radiotherapy for squamous cell cancer of the base of the tongue. Head Neck 9:169-175, 1997

9. List MA, Ritter-Sterr CA, Baker TM, et al: Longitudinal assessment of quality of life in laryngeal cancer patients. Head Neck 18:1-10, 1996[Medline]

10. List MA, Mumby P, Haraf D, et al: Performance and quality of life outcome in patients completing concomitant chemoradiotherapy protocols for head and neck cancer. Qual Life Res 6:274-284, 1997[Medline]

11. List MA, Siston A, Haraf D, et al: Quality of life and performance in advanced head and neck cancer patients on concomitant chemoradiotherapy: A prospective examination. J Clin Oncol 17:1020-1028, 1999[Abstract/Free Full Text]

12. Lazarus CL, Logemann JA, Pauloski BR, et al: Swallowing disorders in head and neck cancer patients treated with radiotherapy and adjuvant chemotherapy. Laryngoscope 160:1157-1166, 1996

13. Logemann JA, Pauloski BR, Rademaker AW, et al: Speech and swallow function after tonsil/base of tongue resection with primary closure. J Speech Hearing 36:918-926, 1993

14. McConnel FMS, Pauloski BR, Logemann JA, et al: The functional results of primary closure versus flaps in oropharyngeal reconstruction: A prospective study of speech and swallowing. Arch Otolaryngol Head Neck Surg 124:625-630, 1998

15. Pauloski BR, Logemann JA, Rademaker AW, et al: Speech and swallowing function after oral and oropharyngeal resections: One year follow-up. Head Neck 16:313-322, 1994[Medline]

16. Rademaker AW, Logemann JA, Pauloski BR, et al: Recovery of postoperative swallowing in patients undergoing partial laryngectomy. Neck 15:325-334, 1993

17. List MA, Ritter-Sterr C, Lansky SB: A performance status scale for head and neck cancer. Cancer 66:564-569, 1990[Medline]

18. List MA, D’Antonio LL, Cella DF, et al: The Performance Status Scale for Head and Neck Cancer Patients and the Functional Assessment of Cancer Therapy-Head and Neck Scale: A study of utility and validity. Cancer 77:2294-2301, 1996[Medline]

19. Cella DF: Manual for the Functional Assessment of Cancer Therapy (FACT) Measurement System (version 3). Chicago, IL,Rush Medical Center, 1994

20. Sharp HM, List MA, MacCracken E, et al: Patients’ priorities in treatment for head and neck cancer: Evaluation of a new assessment tool. Head Neck 21:538-546, 1999[Medline]

21. Tsevat J, Dawson NV, Wu AW, et al: Health values of hospitalized patients 80 years or older: HELP Investigators—Hospitalized Elderly Longitudinal Project. JAMA 279:371-375, 1998[Abstract/Free Full Text]

22. Otto RA, Dobie RA, Lawrence V, et al: Impact of laryngectomy on quality of life: Perspective of the patient versus that of the health care provider. Laryngol 106:693-699, 1997

23. Deleyiannis FW, Weymuller EA Jr, Coltrera MD: Quality of life of disease-free survivors of advanced (stage III or IV) oropharyngeal cancer. Head Neck 19:466-473, 1997[Medline]

24. Dropkin MJ: Coping with disfigurement/dysfunction and length of hospital stay after head and neck cancer surgery. Head Neck Nurs 15:22-26, 1997

Submitted March 15, 1999; accepted October 19, 1999.

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