Implementing Routine Screening for Distress, the Sixth Vital Sign, for Patients With Head and Neck and Neurologic Cancers

Authors: Barry D. Bultz PhDa, Amy Waller PhDa, Jodi Cullum PhDa, Paula Jones MAa, Johan Halland BAa, Shannon L. Groff BSca, Catriona Leckie RN, MN, NPa, Lisa Shirt RN, MNa, Scott Blanchard RN, BN, BAa, Harold Lau MDa, Jacob Easaw MD, PhDa, Konrad Fassbender PhDa, and Linda E. Carlson PhDa
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  • a From the Department of Psychosocial Resources, Tom Baker Cancer Centre; Department of Oncology, University of Calgary; Research and Evaluation Unit, Alberta Health Services, University of Calgary; and Department of Oncology, Tom Baker Cancer Center, University of Calgary, Calgary Alberta; and the Department of Oncology, Division of Palliative Care Medicine, University of Alberta, Edmonton, Alberta, Canada.

This study examined the benefits of incorporating screening for distress as a routine part of care for patients with head and neck and neurologic cancers in a tertiary cancer center. Using a comparative 2-cohort pre-post implementation sequential design, consecutive outpatients with head and neck and neurologic cancers were recruited into 2 separate cohorts. Cohort 1 included patients attending clinics during April 2010, before the implementation of the screening program. The program was then implemented and patients completed the Screening for Distress Minimum Dataset (the Edmonton Symptom Assessment System [ESAS] and the Canadian Problem Checklist [CPC]) at each clinic visit. Cohort 2 included patients attending clinics during March 2011. Consenting patients completed screening and outcome measures (ESAS, CPC, and either the Functional Assessment of Cancer Therapy-Brain or the Functional Assessment of Cancer Therapy-Head and Neck). A total of 146 patients (78 head and neck and 68 neurologic) provided data for Cohort 1, and 143 (81 head and neck and 62 neurologic) provided data for Cohort 2. Compared with Cohort 1, patients with neurologic cancers in Cohort 2 reported significantly higher scores on the Functional Assessment of Cancer Therapy: General total and emotional quality of life subscale; fewer high scores (≥4) on the ESAS breathlessness item; and fewer problems with fears/worries, frustration/anger, finding meaning in life, and worry about friends/family. Head and neck patients in Cohort 2 reported significantly higher emotional quality of life and fewer problems with eating and weight than those in Cohort 1. Although no definitive causal attributions can be made, patients exposed to routine screening for distress reported better well-being and fewer emotional, physical, and practical problems than historical controls.

NCCN: Continuing Education

Accreditation Statement

This activity has been designated to meet the educational needs of physicians and nurses involved in the management of patients with cancer. There is no fee for this article. No commercial support was received for this article. The National Comprehensive Cancer Network (NCCN) is accredited by the ACCME to provide continuing medical education for physicians.

NCCN designates this journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

NCCN is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center‘s Commission on Accreditation.

This activity is accredited for 1.0 contact hour. Accreditation as a provider refers to recognition of educational activities only; accredited status does not imply endorsement by NCCN or ANCC of any commercial products discussed/displayed in conjunction with the educational activity. Kristina M. Gregory, RN, MSN, OCN, is our nurse planner for this educational activity.

All clinicians completing this activity will be issued a certificate of participation. To participate in this journal CE activity: 1) review the learning objectives and author disclosures; 2) study the education content; 3) take the posttest with a 66% minimum passing score and complete the evaluation at http://education.nccn.org/node/30707; and 4) view/print certificate.

Release date: October 25, 2013; Expiration date: October 25, 2014

Learning Objectives

Upon completion of this activity, participants will be able to:

  • Discuss the benefits that implementing a routine distress screening program had on patient-reported outcomes

  • Describe strategies to successfully implement screening for distress and ensure that services are provided to patients in response to concerns

Cancer often presents a variety of physical, emotional, practical, and spiritual challenges for patients and their families. With an increasing number of studies reporting a high prevalence of distress in cancer patients,1,2 several national and international organizations have now endorsed distress as the sixth vital sign.3 Routine screening for distress has the potential to help practitioners identify and manage the psychosocial, practical, and physical concerns that may contribute to patient distress.4 Strategies to successfully implement screening for distress and ensure that services are provided to patients in response to these concerns are now being explored.5

Studies examining the impact of screening for distress report mixed results, partly because of differences in design, interventions, and outcomes.5 In this analysis, only 6 of 12 (50%) randomized trials, but 7 of 8 nonrandomized trials, showed a positive effect on psychological well-being. Improvements were also seen in communication, clinician behavior, and referrals, and in patient and staff satisfaction.6 Although they successfully demonstrated efficacy, many programs were not integrated within clinical settings, and in some cases required designated trials staff and funding.7 The crucial question now is whether a routine screening program would be effective and sustainable without these additional resources, and be acceptable to patients and frontline clinic staff.7

A desire exists on the part of staff for more evidence surrounding implementation of screening and advice on how to overcome some of the most common barriers to successful screening, including timing, cost, technology, and appropriate measurement tools.8 Few studies have fully explored the clinical implementation of programs for distress screening. Two Canadian studies reported on key barriers and facilitators to clinical implementation of screening for distress, concluding that programs were an important and feasible change in practice that improved team functioning and patient-centered care.9,10 However, neither of these studies described the impact of the program on patient-reported outcomes. Other studies are limited by the lack of a control group for comparison between the new and old screening procedure,11,12 a lack of power, and limited follow-up provided to patients with distress.13

Building on the authors’ own previous findings showing the efficacy of screening programs when conducted by specialized psychosocial oncology staff,14,15 a model of screening for distress was developed that could be integrated into regular clinical practice and run by frontline clinic staff. Screening was linked with follow-up care and services, including psychosocial resources, pain and fatigue clinics, nutrition services, and palliative care, using referral guidelines and triage algorithms. A staff training and feedback component was also included as an important part of the implementation process.7

The authors chose to evaluate this new program in the head and neck and neurologic outpatient clinics at Tom Baker Cancer Centre. Although these clinics are relatively small, patients often report high levels of symptom burden, needs, and concerns.16,17 Few studies have examined the benefits of psychosocial interventions in these tumor groups.16,17 The current study sought to examine the benefits of implementing a routine screening for distress program based on patient-reported outcomes.

Methods

Objective

The objective of this study was to compare quality of life, physical symptoms, and common psychological and practical problems in 2 cohorts of patients: those attending treatment clinics before and after the introduction of a comprehensive, routine screening for distress program.

Study Design

Although randomized controlled trials are accepted as the gold standard, the authors recognized the possible contamination of staff trained in making use of screening results. The knowledge and skills staff learn as part of the screening intervention may carry over to patients enrolled in the usual care arm,18 especially when seen by the same staff members, which is the case at the authors’ center. Given the focus on effectiveness, they decided to use a sequential cohort design; Cohort 1 represented patients assessed before the screening for distress program was implemented (usual care) and Cohort 2 represented those assessed after 10 months of program implementation and refinement.

Participants

Participants included all patients who had at least one prior visit at a participating clinic, were aged 18 years and older, and attended the neurologic and head and neck outpatient clinics at the Tom Baker Cancer Centre during April 2010 (Cohort 1) and March 2011 (Cohort 2). Patients were excluded if they were too ill to participate or were unable to read/speak English and did not have an interpreter.

Procedure

Cohort 1: Eligible patients were approached by a research staff member for consent in the waiting room of the outpatient clinic before their clinic appointment. Consenting patients completed a paper and pen questionnaire in the waiting room. Screening scores were not made available to the clinic staff and no triage was undertaken for these patients beyond the standard care provided by the clinic. This provided a picture of the clinic as it was operating before implementation of the program. Patients from both cohorts were required to have had at least one prior clinic visit before the assessment visit to be included in the study. This ensured that they all had prior exposure to the prevailing clinical environment before being assessed.

Screening for Distress Program Implementation: After the data collection for Cohort 1, the screening program was implemented in the head and neck and neuro-oncology clinics over a 10-month period. At the beginning of the implementation, staff presentations and education sessions were held and champions were identified in the clinics to assist with the implementation and mentor fellow staff members. Guidelines and training on how to have the conversation with patients and when and how to refer was provided to staff (Figure 1).

Throughout the implementation, particularly in the first 6 months after initiation of the program, quality improvement methodology was used to address challenges and increase the percentage of patients screened. Quality improvement is an ongoing process that involves continually identifying and addressing areas in which process change is required.19 Plan-Do-Study-Act cycles were used, in which clinical processes were reviewed and modified as required.

Cohort 2: Ten months after the implementation of the screening program, a second 4-week data collection phase occurred (Cohort 2). Eligible patients were approached by a staff member for consent in the waiting room of the outpatient clinic before their appointment. Consenting patients completed the same paper and pen questionnaire as patients in Cohort 1. However, as was by the clinical practice by then, the screening scores recorded on the questionnaire were made available to the clinic nurse. The nurse reviewed the screening scores with the patient at the same consultation and provided referrals as required at that time. Consistent with the training provided throughout implementation, the nurse managed any concerns within their scope of practice, directed additional concerns to the oncologist if appropriate, and made any necessary referrals to services. The nurse reviewed the screening scores and made referrals at the same consultation. All of these patients had been exposed to the clinic environment, incorporating screening at least once prior to the assessment of study outcome measures.

Screening Measures

The Canadian Partnership Against Cancer has recommended the Screening for Distress minimum data set, which includes the Edmonton Symptom Assessment System (ESAS) and the Canadian Problem Checklist (CPC).20

Figure 1
Figure 1

Triage and referral algorithms.

Abbreviation: TBCC, Tom Baker Cancer Centre.

Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 11, 10; 10.6004/jnccn.2013.0147

Edmonton Symptom Assessment System: The ESAS21 is a 10-item measure assessing symptoms on a visual analogue scale of 0 through 10 (10 = worst), including anxiety, appetite, depression, drowsiness, nausea, pain, shortness of breath, tiredness, and well-being. The validity and reliability have been established in palliative care and general cancer populations. Higher scores indicate worse symptom burden. A cutoff of 4 or more was used to indicate a high symptom burden, as recommended by the Canadian Partnership Against Cancer Screening for Distress Guidelines.20

The Canadian Problem Checklist: The CPC20 includes 6 emotional (frustration/anger, changes in appearance, fears and worries, change in who I am, intimacy/sexuality, sadness); 3 social/family (feeling alone, feeling a burden, worry about family/friends); 5 informational (treatment decisions, taking medications, knowing about resources, talking with health care team, understanding illness/treatment); 2 spiritual (faith, meaning/purpose); 5 practical (accommodation, finances, quitting smoking, getting to and from appointments, work/school concerns); and 9 physical concerns (bowels, eating or enjoying food, physical inactivity, concentration/memory, mobility, seizures, sleep, weight, wound care).

Outcome Measures

Patients in both cohorts completed the appropriate outcome measure for their type of cancer during the 4-week data collection phases.

Functional Assessment of Cancer Therapy - Brain, Version 4: The Functional Assessment of Cancer Therapy - Brain (FACT-Br), Version 4,22 is a 50-item validated measure of quality of life for patients diagnosed with brain cancer, composed of the Functional Assessment of Cancer Therapy: General (FACT-G) and brain tumor subscale. The total FACT-G score is calculated by summing all the subscale scores (physical well-being [PWB], functional well-being [FWB], social/family well-being [SWB], emotional well-being [EWB]). A total FACT-Br score is calculated by summing all the subscales and the brain tumor subscale. The Trial Outcome Index score is calculated by summing the PWB, FWB, and the brain tumor subscale. Higher scores indicate higher quality of life for all scores. Minimal important differences (MIDs) have been established for the FACT-G total score (3-7 points), the EWB subscale (≥2 points), and the PWB and FWB subscales (2-3 points).23

Functional Assessment of Cancer Therapy - Head and Neck, Version 4: The Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN), Version 424 is a 39-item validated measure of quality of life for patients diagnosed with head and neck cancer, composed of the FACT-G and head and neck subscale. Scoring follows the same format as for the FACT-Br. MIDs have been established for the FACT-HN total score (6-12 points).23

Statistical Analysis

Baseline demographic and disease characteristics were compared between the cohorts for each tumor group using independent t-test for continuous and χ2 tests for categorical variables. The percentage of participants in each cohort reporting ESAS symptom scores of 4 or more and individual problems on the CPC were compared using χ2 tests. Continuous FACT subscale and total scores were compared between Cohort 1 and Cohort 2 using independent t-tests.

Results

Participants

A total of 161 patients consented to participate in Cohort 1 (80.1% of eligible population); 55.9% were diagnosed with a head and neck tumor and 44.1% were diagnosed with a neurologic tumor. A total of 185 patients consented to participate in Cohort 2 (81.1% of eligible population). Only patients who had presented at the clinic at least once before the date they completed the outcome measures (to ensure exposure) were included in this analysis for both Cohorts. In Cohort 1, a total of 146 patients met this criterion; 53.4% with head and neck and 46.6% with neurologic tumors. In Cohort 2, a total of 143 patients met this criterion; 52.6% with head and neck and 47.4% with neurologic tumors (Table 1). Screening was adopted by clinics and routinely offered to more than 90% of all patients with the target tumor groups.

Edmonton Symptom Assessment System

Neurologic: Figure 2 presents the percentage of patients in each cohort reporting scores of 4 or more (4 being the cutoff for moderate distress) on the ESAS items. Fewer patients in Cohort 2 than in Cohort 1 reported high scores on the breathlessness item (indicating worst possible shortness of breath; χ 2=7.23; P=.007).

Table 1

Demographics and Medical Interventions for Participants in Cohorts 1 and 2 at Time of Screening

Table 1
Table 1
Figure 2
Figure 2

Percentage of patients with neurologic cancer in each cohort reporting scores of ≥ 4 on the Edmonton Symptom Assessment System.

*P<.05.

Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 11, 10; 10.6004/jnccn.2013.0147

Head and Neck: Figure 3 presents the percentage of patients in each cohort reporting scores of 4 or more on the ESAS. Fewer patients in Cohort 2 than in Cohort 1 reported high scores on the well-being item (indicating worst possible well-being; c=4.23; P=.04).

Canadian Problem Checklist

Neurologic: Figure 4 presents the percentage of patients endorsing each of the items on the CPC. Fewer patients in Cohort 2 than in Cohort 1 reported problems with frustration/anger (χ2=5.62; P=.018), worry about friends/family (χ2=3.65; P=.043), fears and worries (χ2=5.13; P=.024), and finding meaning in life (χ2=4.74; P=.036).

Figure 3
Figure 3

Percentage of patients with head and neck cancer in each cohort reporting scores of ≥ 4 on the Edmonton Symptom Assessment System

*P<.05.

Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 11, 10; 10.6004/jnccn.2013.0147

Head and Neck: Figure 5 presents the percentage of patients endorsing each of the items on the CPC. Fewer patients in Cohort 2 than in Cohort 1 reported problems with eating/food (χ2=4.86; P=.027) and weight (χ2=10.87; P=.001).

Figure 4
Figure 4

Percentage of patients with neurologic cancer in each cohort endorsing individual items on the Canadian Problem Checklist.

*P<.05.

Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 11, 10; 10.6004/jnccn.2013.0147

FACT

Neurologic: More patients in Cohort 2 than in Cohort 1 reported significantly higher FACT emotional (t = -13.97; P<.001) and FACT-G total (t = -3.50; P=.001) quality of life scores, indicating better overall quality of life (Figure 6). Patients in Cohort 2 reported a significantly higher trial outcomes index (M=134.6 vs M=106.6; t = -4.35; P<.001) than patients in Cohort 1, indicating higher PWB/FWB well-being, and a higher total FACT-Br score (M=93.3 vs M=77.9; t = -6.74; P<.001), again indicating better quality of life. The authors found MIDs between the cohorts in terms of the FACT-G total (between 3 and 7 points) and EWB subscale (>2 points) scores.

Figure 5
Figure 5

Percentage of patients with head and neck cancer in each cohort endorsing individual items on the Canadian Problem Checklist.

*P<.05.

Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 11, 10; 10.6004/jnccn.2013.0147

Head and Neck: Patients in Cohort 2 reported significantly higher FACT-G emotional quality of life compared with patients in Cohort 1 (t=85.87; P<.001; Figure 6). No significant differences were seen between the cohorts in the reported head and neck additional concerns subscale, the trial outcomes index, and the total score for the FACT-HN. MIDs were found in the FACT-G emotional (>2 points) scores.

Discussion

The objective in this study was to examine the changes accompanying incorporation of a screening for distress program as part of routine care for outpatients with head and neck and neurologic cancers in a tertiary cancer center. Changes were assessed by comparing differences in patient-reported quality of life, symptoms, and common psychosocial, practical, and physical problems between 2 patient cohorts recruited before and after the implementation of the program. Many improvements were seen in both tumor groups and across a range of symptoms, quality of life domains, and common problems after program implementation.

After implementation of the screening program, patients with neurologic cancers reported statistically and clinically significantly higher total and emotional quality of life and higher PWB and FWB as measured by the FACT-Br Trial Outcome Index. This difference is large and striking, especially given that patients with neurologic cancers often report high levels of depression, fatigue, distress, and existential concerns, often exacerbated by aggressive treatment regimens and poor prognosis.25 Patients with neurologic cancers typically report lower quality of life, irrespective of the time since diagnosis or treatment,26 so the potential for a screening for distress program to improve these outcomes is an important finding.

Figure 6
Figure 6

The mean scores on the Functional Assessment of Cancer Therapy: General for patients with neurologic and head and neck cancers in each cohort.

*P<.05.

Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 11, 10; 10.6004/jnccn.2013.0147

Patients with head and neck cancers in Cohort 2 also reported significantly and clinically higher emotional quality of life scores compared with those in Cohort 1. This finding also has important clinical implications, because reduced health-related quality of life has been associated with reduced survival in these patients. Head and neck cancer is often diagnosed in advanced stages.28 For many patients, survival rates have not improved considerably.27 In addition to pain and fatigue, patients with head and neck cancers report physical and social concerns related to eating, communication, and changes in appearance,17 and higher levels of distress, anxiety, and depression than patients in other tumor groups.28

In terms of ESAS outcomes, fewer patients with neurologic cancers in Cohort 2 had problems with breathlessness; and patients with head and neck cancers reported greater well-being than those assessed before implementation of screening for distress. These improvements may be related to the specific referrals patients received to help with these issues. For example, patients reporting scores of 4 or more on the breathlessness item were instructed to discuss this symptom with their health care team, whereas patients scoring 4 or more on the well-being item were referred to the Department of Psychosocial Resources.

Fewer specific problems were also reported in patients with neurologic cancer after screening for distress was implemented, including decreases in fears, worries, frustration, anger, and worry about friends and family, and improvements were seen in finding meaning in life. These problems are common, and along with physical problems, emotional issues are most frequently reported and consistently associated with high distress in studies of patients with mixed cancer29 and brain cancer.30 Notably, although patients with neurologic cancer in Cohort 2 improved on measures of fears and worries, frustration/anger, and worries about friends and family on the CPC, they did not report less overall anxiety and depression on the ESAS. This may be a result of adequate attention already being paid to anxiety and depression levels in the clinics. The addition of screening may have allowed for detection of lower levels of distress related to specific problems that may not previously have been detected by clinical acumen alone, and therefore they were more adequately addressed.

Fewer problems with eating, food, and weight were also reported by patients with head and neck cancers in Cohort 2. More than 50% of patients with head and neck cancer report weight loss and possible cachexia.31 Coupled with this susceptibility to weight loss, patients with head and neck cancer are also at higher risk for malnutrition compared with patients in other tumor groups.31 Weight and nutritional problems are linked to infection, anxiety, and depression, and reduced quality of life, resistance to treatment toxicity, longer time to recurrence, and survival,31 and therefore assessment of these concerns should begin at diagnosis. If this program helped to address these concerns, it represents an important contribution to the care of these patients. The CPC is an adaptation of the problem checklist recommended by the NCCN Clinical Practice Guidelines in Oncology for Distress Management (to view the most recent version of these guidelines, visit NCCN. org).32 As such, it has been used extensively in clinical research, but not formally psychometrically validated.

The main limitation of this study, which allows only speculation that screening for distress was the causal agent in the observed changes, is the use of nonrandomized cohorts separated by a period of 1 year. Rather than conducting a large and more expensive cluster randomized clinical trial initially, although this would have been a more rigorous design, the authors decided to first establish the feasibility of this approach in this study. Other factors could potentially account for the positive changes observed, including other changes in clinic procedures, different staffing, physical setup, changes to the health system, or historical societal changes. Although these factors cannot be ruled out, other changes were tracked where possible. No changes to clinic location, key staffing, or procedures were implemented, and assessments were conducted at the same time of year to account for predictable seasonal variability.

The use of patients who were newly diagnosed, on treatment, and in follow-up provides a realistic picture of the clinics as they operate on a daily basis. Although screening was adopted by clinics and routinely offered to more than 90% of all patients with the target tumor groups, they represent only a small proportion of all patients with cancer attending the Tom Baker Cancer Centre. Hence, the impact longitudinally with other, larger tumor groups needs to be explored to demonstrate the feasibility of routinely screening patients in the outpatient clinics using only existing clinical resources. This will also provide important information about the ability of the program to be flexible and adaptable to the differing needs of patients as they progress through their cancer trajectory. Service use data collected for the purpose of conducting an economic analysis will be reported in a future paper.

In summary, patients with neurologic and head and neck cancers reported improved well-being and fewer emotional, physical, and practical problems after exposure to routine screening for distress in clinical practice. A recurring call exists for sustainable programs that can be administered by existing staff members, and further work is needed to examine the benefits of screening programs over longer follow-up and in larger tumor groups.

This study was supported by a grant from the Advisory Committee of Research, Alberta Cancer Board and Alberta Cancer Foundation. Dr. Carlson holds the Enbridge Research Chair in Psychosocial Oncology, co-funded by the Alberta Cancer Foundation and the Canadian Cancer Society Alberta/NWT Division, and an Alberta Heritage Foundation for Medical Research Health Scholar Award. Dr. Waller and Ms. Groff hold the Psychosocial Oncology Research Training (PORT) fellowships. The authors have disclosed that they have no financial interests, arrangements, affiliations, or commercial interests with the manufacturers of any products discussed in this article or their competitors.

EDITOR

Kerrin M. Green, MA, Assistant Managing Editor, JNCCN—Journal of the National Comprehensive Cancer Network

Ms. Green has disclosed that she has no relevant financial relationships.

CE AUTHORS

Deborah J. Moonan, RN, BSN, Manager, CE Supporter Outreach

Ms. Moonan has disclosed the following relationship with commercial interests: AstraZeneca: Stockholder/Former Employee.

Kristina M. Gregory, RN, MSN, OCN, Vice President, Clinical Information Operations

Ms. Gregory has disclosed that she has no relevant financial relationships.

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    Holland JC, Andersen B, Breitbart WS et al.. NCCN Clinical Practice Guidelines in Oncology: Distress Management. Version 2, 2013. Available at: NCCN.org. Accessed September 6, 2013.

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Correspondence: Barry D. Bultz, PhD, Department of Psychosocial Oncology, Tom Baker Cancer Centre; Cancer Control Alberta; and Faculty of Medicine, University of Calgary, 1331 29th Street NW, Calgary, Alberta, Canada, T2N-4N2. E-mail: bdbultz@ucalgary.ca

Supplementary Materials

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    Triage and referral algorithms.

    Abbreviation: TBCC, Tom Baker Cancer Centre.

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    Percentage of patients with neurologic cancer in each cohort reporting scores of ≥ 4 on the Edmonton Symptom Assessment System.

    *P<.05.

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    Percentage of patients with head and neck cancer in each cohort reporting scores of ≥ 4 on the Edmonton Symptom Assessment System

    *P<.05.

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    Percentage of patients with neurologic cancer in each cohort endorsing individual items on the Canadian Problem Checklist.

    *P<.05.

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    Percentage of patients with head and neck cancer in each cohort endorsing individual items on the Canadian Problem Checklist.

    *P<.05.

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    The mean scores on the Functional Assessment of Cancer Therapy: General for patients with neurologic and head and neck cancers in each cohort.

    *P<.05.

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