Initial psychometric testing of the Head and Neck Cancer Patient Self-Management Inventory (HNC-PSMI).

PURPOSE: Head and neck cancer (HNC) and its treatment are associated with significant symptom burden and functional impairment. HNC patients must engage in intensive and complex self-management protocols to minimize acute and late treatment effects. Self-management among HNC patients is understudied due to the limited availability of disease-specific self-management measures. This article describes the initial psychometric testing of the HNC Patient Self-Management Inventory (HNC-PSMI), an instrument that characterizes self-management tasks in the HNC population. METHOD: A cross-sectional survey design was used. One hundred HNC patients completed the HNC-PSMI, the Vanderbilt Head and Neck Cancer Symptom Survey plus General Symptom Survey, and the Profile of Mood States-Short Form. To evaluate the psychometric properties of the HNC-PSMI, the relevance of items, internal consistency of domain item responses, and the direction and strength of associations between domain scores and other measures were examined. RESULTS: There was variability both in the number of self-management tasks performed overall and in each domain as well as in the reported difficulty completing those tasks. Kuder-Richardson values for domains with > 3 items ranged from 0.61 to 0.86. Hypothesized associations were supported. CONCLUSIONS: Overall, the psychometric properties for the HNC-PSMI were acceptable. The HNC-PSMI can be used to advance an understanding of self-management requirements and challenges in HNC patients.

A Comparison of the Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC) and Pain Assessment in Advanced Dementia Scale (PAINAD).

BACKGROUND: There is currently no gold standard instrument for assessing pain in severely cognitively impaired adults who are unable to provide self-report. AIMS: To determine interrater reliability of the PACSLAC and PAINAD in assessing pain behaviors in patients with the same pain stimulus, determine the consistency of the reliable changes between and within the instruments and assess nurse preference for either instrument. DESIGN: A single-group, within-subjects repeated-measures design was implemented. SETTING: The study took place in a small suburban hospital. PARTICIPANTS/SUBJECTS: Pain levels were observed at 24, 48, and 72 hours postsurgery using two instruments: Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC) and Pain Assessment in Advanced Dementia Scale (PAINAD). These instruments were selected because they are among the most commonly recommended tools for clinical use. Interrater reliability was analyzed along with reliable changes in pain for each period, and the study concluded with the nurse raters completing a preference survey. METHODS: A convenience sample of 30 patients was used with a diagnosis of severe dementia rendering the patient unable to reliably express pain, 60+ years of age, recovering from hip fracture surgery. RESULTS: Greater interrater reliability was found for the PACSLAC, with reliable change potentially affected by the type and level of pain medication. The nurses' preference for the tool was split. CONCLUSIONS: The results of this study indicate that the PACSLAC may be the more reliable tool over the PAINAD; however, rater training and familiarity with the tool is critical.

Impact of patient symptoms and caregiving tasks on psychological distress in caregivers for head and neck cancer (HNC).

OBJECTIVE: To determine the association of caregiving task burden and patient symptom burden with psychological distress among caregivers of head and neck cancer (HNC) patients. METHODS: Adults with HNC and their primary caregivers were included. Patient symptom burden was assessed with the Vanderbilt Head and Neck Symptom Survey-2.0. Caregiving task burden was quantified as task number and task difficulty/distress using the HNC Caregiving Task Inventory. Psychological distress was measured with the Profile of Mood States-Short Form. Two-step clustering analysis was conducted for patient symptom burden, caregiving task burden, and psychological distress. Associations of the resultant clusters of task burden and patient symptoms with caregiver distress were tested using logistic regressions. RESULTS: Eighty-nine HNC caregivers and 84 patients were included. Among patients, two clusters of symptom burden were found (51% mod-high, 49% low). Among caregivers, two clusters of caregiving task burden (40% mod-high, 60% low) and caregiver psychological distress (40% mod-high, 60% low) were found. Caregivers with mod-high task numbers and task difficulty/distress reported higher levels of psychological distress. After controlling for caregiver number of tasks, respective difficulty/distress, and patient symptom burden, caregiver perceived task difficulty/distress had the strongest association with caregiver psychological distress (adjusted OR = 3.83; 95% CI, 1.0-14.64; P = 0.049). CONCLUSIONS: Psychological distress in HNC caregivers is associated with caregiving task burden, with caregivers experiencing high task difficulty/distress at greatest risk. Further study of the caregiver and task characteristics leading to psychological distress should inform supportive interventions for HNC patients and caregivers.

Nurse-Delivered Symptom Assessment for Individuals With Advanced Lung Cancer.

OBJECTIVES: To assess an intervention derived from self-regulation theory (SRT) to promote well-being for individuals with advanced lung cancer. SAMPLE & SETTING: 45 adults with advanced lung cancer who were receiving chemotherapy at an ambulatory cancer center. METHODS & VARIABLES: Participants were randomized to the intervention group or usual care control group. Feasibility assessment focused on recruitment, retention, design, methods, and fidelity. Outcome measures of quality of life, symptoms, and distress were collected at four time points. The main research variables were symptoms, quality of life, and distress. RESULTS: The participation rate was 79%, and the retention rate was 62%. Participant loss was most often because of progressive disease and occurred early in the study. High fidelity was noted for delivery of the intervention as planned and outcome data collection by telephone. The mean number of interventions delivered was 5.5 of a planned 8. A high level of acceptability was reported for participants completing the intervention. IMPLICATIONS FOR NURSING: Although delivering the SRT-derived intervention with fidelity was possible, feasibility findings do not warrant intervention replication in this population.

Development of the Head and Neck Cancer Caregiving Task Inventory.

PURPOSE: Family caregivers provide vital support for patients with head and neck cancer (HNC), yet few studies have focused on HNC caregiving. Our objective was to develop and conduct initial validation of the HNC Caregiving Task Inventory, an instrument to characterize caregiving task burden in the HNC population. METHODS: This 5-phase instrument development project involved the conceptualization of caregiving task burden (Phase 1), initial instrument development (Phase 2), assessment of content validity through expert panel review (Phase 3), assessment of face validity through family caregiver review (Phase 4), and preliminary validation in a sample of 106 family caregivers (Phase 5). RESULTS: We identified 11 domains of the HNC caregiving role and caregiving tasks for each domain. In Phase 3, the experts deemed all tasks relevant to HNC family caregiving. No tasks were eliminated and 19 were added. In Phase 4, family caregiver feedback indicated that the tasks were comprehensive and relevant. Wording and formatting changes were made and one task was added. In Phase 5, we evaluated discrimination of responses to derive a final version comprised of 58 tasks in 11 domains. Kuder-Richardson values for domains with ≥3 items ranged from 0.65 to 0.94. Associations were generally high with the Caregiving Burden Scale, moderate with the Caregiver Reaction Assessment and Profile of Mood States-Short Form, and low or non-existent with the Preparedness Scale. CONCLUSION: Convergent and divergent validity were supported. The HNC Caregiving Task Inventory can be used to evaluate caregiving task burden across the treatment trajectory and identify targets for intervention.

Measuring Clinical Decision Support Influence on Evidence-Based Nursing Practice.

PURPOSE/OBJECTIVES: To measure the effect of clinical decision support (CDS) on oncology nurse evidence-based practice (EBP).
. DESIGN: Longitudinal cluster-randomized design.
. SETTING: Four distinctly separate oncology clinics associated with an academic medical center.
. SAMPLE: The study sample was comprised of randomly selected data elements from the nursing documentation software. The data elements were patient-reported symptoms and the associated nurse interventions. The total sample observations were 600, derived from a baseline, posteducation, and postintervention sample of 200 each (100 in the intervention group and 100 in the control group for each sample).
. METHODS: The cluster design was used to support randomization of the study intervention at the clinic level rather than the individual participant level to reduce possible diffusion of the study intervention. An elongated data collection cycle (11 weeks) controlled for temporary increases in nurse EBP related to the education or CDS intervention.
. MAIN RESEARCH VARIABLES: The dependent variable was the nurse evidence-based documentation rate, calculated from the nurse-documented interventions. The independent variable was the CDS added to the nursing documentation software.
. FINDINGS: The average EBP rate at baseline for the control and intervention groups was 27%. After education, the average EBP rate increased to 37%, and then decreased to 26% in the postintervention sample. Mixed-model linear statistical analysis revealed no significant interaction of group by sample. The CDS intervention did not result in an increase in nurse EBP.
. CONCLUSIONS: EBP education increased nurse EBP documentation rates significantly but only temporarily. Nurses may have used evidence in practice but may not have documented their interventions.
. IMPLICATIONS FOR NURSING: More research is needed to understand the complex relationship between CDS, nursing practice, and nursing EBP intervention documentation. CDS may have a different effect on nurse EBP, physician EBP, and other medical professional EBP.

Preliminary evaluation of reliability and validity of head and neck external lymphedema and fibrosis assessment criteria.

PURPOSE: Measurement of head and neck external lymphedema and fibrosis (LEF) is challenging. To address this gap, we developed the Head and Neck External Lymphedema and Fibrosis (HN-LEF) Assessment Criteria. This article aimed to report preliminary data on reliability and validity of the HN-LEF Assessment Criteria. METHODS: Sixty head and neck cancer (HNC) patients who were ≥3-month post cancer therapy were recruited. Study measures included 1) demographic/medical data; 2) LEF physical examination completed independently by two staff members for interrater reliability (intrarater reliability completed by one of them); and 3) grayscale ultrasound examination of the head and neck skin. Reliability estimates used percent agreement and Kappa statistic. Validity was assessed via Spearman correlations of physical examination findings with ultrasound measurements. RESULTS: Fifty-one out of 60 HNC patients completed both physical examination and ultrasound assessments. Interrater reliability: 91.0% agreement (Kappa = 0.81, p < 0.001) on the presence of types of LEF; 84.9% agreement regarding the grade of LEF (Kappa = 0.70, p < 0.001) across all anatomic sites. Intrarater reliability: 96.1% agreement for type of LEF; and 91.4% agreement for grade across all sites. Ultrasound examination demonstrates characteristics and patterns for different types of LEF (particularly in the cheek, submental, and neck regions). CONCLUSIONS: The study provided initial reliability and validity data for a clinician-reported tool evaluating external LEF in the HNC population. These preliminary findings demonstrate that the tool had good reliability. Associations with the ultrasound examination results demonstrate that the tool validly captures soft tissue changes at select sites. Further validation of the tool is warranted.

Art to Heart: The Effects of Staff- Created Art on the Postoperative Rehabilitation of Cardiovascular Surgery Patients.

Postoperative ambulation is important for reducing complications following surgery. The type of art patients view on the ambulation route may influence the distance patients walk. In this study, patients ambulated greater distances when staff-created art was placed on hallway walls.

Rural middle school nutrition and physical activity environments and the change in body mass index during adolescence.

BACKGROUND: For rural adolescents, schools are among the few places where environmental interventions can promote health outside of the home. The goal of this study was to assess the nutrition and physical activity (N&PA) environments of schools attended by a birth cohort and examine the association with change in body mass index (BMI) from sixth to eighth grade. METHODS: Using data from adolescents of a rural New York State birth cohort (N = 281), we used linear mixed models to identify N&PA environments associated with change in BMI. We also examined family income trajectory as a potential modifier to consider how the association between school environment and change in BMI might differ depending on income. RESULTS: We found considerable heterogeneity in environments within and between schools. Among students with low-income trajectories, reductions in BMI z-scores were associated with school environments that promote better physical education (PE) and general (non-PE, non-sport) physical activity. Schools with better sports environments were associated with reductions in BMI for some students, but not lower-income students. CONCLUSIONS: School environments may have differing effects on students depending on their socioeconomic status. Strategies are needed to identify and address barriers that impair low-income students' access to health-promoting school resources.

Outcomes toolbox for head and neck cancer research.

BACKGROUND: Clinical research in head and neck cancer traditionally focused on tumor control. As survival improves, it is increasingly recognized that the side-effects of multimodality treatment can be profound and enduring. Thus, clinical trials require patient-reported and functional outcomes. METHODS: A subcommittee of the Previously Untreated, Locally Advanced (PULA) Task Force of the Head and Neck Steering Committee of the Coordinating Centre for Clinical Trials at the National Cancer Institute (NCI) was convened to identify a set of instruments suitable for widespread application in the conduct of clinical trials for head and neck cancer. RESULTS: Based on existing literature and expert opinion, 18 main areas of concern were identified. For each, measures suitable for use in multicenter clinical trials were recommended on the basis of validity, feasibility, and clinical acceptance. CONCLUSION: Suitable instruments exist for most head and neck cancer concerns, but gaps require further development. Future efforts should be made to harmonize measurement across trials.

Development and preliminary testing of head and neck cancer related external lymphedema and fibrosis assessment criteria.

PURPOSE: To develop assessment criteria for evaluating and documenting status of external lymphedema and fibrosis in patients with head and neck cancer (HNC). METHODS: This was a two-phase instrument development study. In Phase I, initial assessment criteria for head and neck external lymphedema and fibrosis were generated based on a conceptual framework developed to describe the continuum of lymphedema - fibrosis in HNC patients. The initial Head and Neck External Lymphedema and Fibrosis (HN-ELAF) Assessment Criteria with three components were revised based on expert feedback. In Phase II, a pilot study was conducted to evaluate the revised assessment criteria through direct physical examination of 30 HNC patients with facial swelling and/or scar-like tissue >3 months post-treatment. The following statistical methods were used to evaluate interrater reliability in Phase II: simple percent agreement, the Kappa statistic, and the concordance correlation coefficient. Then, a post-test revision was made to further modify the tool based on the results of the pilot test. RESULTS: In Phase I, the initial HN-ELAF was revised including deleting Grade 0 (subclinical disease) and two components (i.e., symptoms and functional impairments). The revised HN-ELAF Assessment Criteria demonstrated good content/face validity. In Phase II, the assessment criteria had an acceptable interrater reliability, e.g., 83% exact agreement on grading lymphedema and fibrosis severity; and kappa = 0.75 (p < .001). The assessment criteria were further modified including three dimensions: type, severity, and anatomical sites of lymphedema and fibrosis. CONCLUSIONS: Validation of the modified HN-ELAF Assessment Criteria in larger sample sizes is ongoing.

Study protocol: effects of school gardens on children's physical activity.

BACKGROUND: Childhood obesity is an epidemic. Strategies are needed to promote children's healthy habits related to diet and physical activity. School gardens have the potential to bolster children's physical activity and reduce time spent in sedentary activity; however little research has examined the effect of gardens on children's physical activity. This randomized controlled trial (RCT) examines the effect of school gardens on children's overall physical activity and sedentary behavior; and on children's physical activity during the school day. In addition, physical activity levels and postures are compared using direct observation, outdoors, in the garden and indoors, in the classroom. METHODS/DESIGN: Twelve New York State schools are randomly assigned to receive the school garden intervention or to serve in the wait-list control group that receives gardens and lessons at the end of the study. The intervention consists of a raised bed garden; access to a curriculum focused on nutrition, horticulture, and plant science and including activities and snack suggestions; resources for the school including information about food safety in the garden and related topics; a garden implementation guide provided guidance regarding planning, planting and maintaining the garden throughout the year; gardening during the summer; engaging volunteers; building community capacity, and sustaining the program. Data are collected at baseline and 3 post-intervention follow-up waves at 6, 12, and 18 months. Physical activity (PA) "usually" and "yesterday" is measured using surveys at each wave. In addition, at-school PA is measured using accelerometry for 3 days at each wave. Direct observation (PARAGON) is used to compare PA during an indoor classroom lesson versus outdoor, garden-based lesson. DISCUSSION: Results of this study will provide insight regarding the potential for school gardens to increase children's physical activity and decrease sedentary behaviors. TRIAL REGISTRATION: Clinicaltrial.gov # NCT02148315.

A randomized placebo-controlled pilot study of the impact of healing touch on fatigue in breast cancer patients undergoing radiation therapy.

PURPOSE: This is a pilot study investigating the effect of healing touch (HT) on fatigue in breast cancer patients undergoing radiation therapy (RT). METHODS/DESIGN: This study presents the results of a within-subjects design randomized clinical trial where the treatment group was treated with HT, whereas the control group experienced sham therapy. The setting was a university RT clinic. The participants were breast cancer patients treated with lumpectomy or mastectomy, 21 to 75 years old with an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2. The intervention was a 45-minute session of HT or sham therapy once a week during RT. Outcome measures included fatigue, quality of life (QOL), and anxiety/depression. RESULT: A total of 70 patients were approached, with 41 completing the study. At completion, the HT participants tended to report higher levels of fatigue, statistically significant for interference ( : = .010) and usual fatigue ( : = .024). The control group tended to report greater reductions in fatigue relative to their own means than the HT group (Cohen's : = 0.30 to 0.49 vs 0.06 to 0.18, respectively). There were no statistically significant differences between the groups for QOL. CONCLUSION: Our enrollment and retention indicate that HT is feasible for women during RT. Our pilot findings do not support a beneficial effect of HT on fatigue or QOL. Future research may explore increasing dose and teasing out therapist effect.

Assessment of external lymphedema in patients with head and neck cancer: a comparison of four scales.

PURPOSE/OBJECTIVES: To compare available grading and staging scales that measure external lymphedema in patients with head and neck cancer (HNC) and to assess problems and gaps related to these tools. DESIGN: Cross-sectional. SETTING: A comprehensive cancer center in Tennessee. SAMPLE: 103 participants post-HNC treatment. METHODS: Four scales were used to evaluate study participant external lymphedema status, including the Common Terminology Criteria for Adverse Events (CTCAE) Lymphedema Scale (version 3.0), American Cancer Society Lymphedema Scale, Stages of Lymphedema (Földi's Scale), and the CTCAE Fibrosis Scale (version 3.0). MAIN RESEARCH VARIABLES: Occurrence rate, severity of lymphedema, and components and descriptors of each scale. FINDINGS: The prevalence and severity of external lymphedema differed based on the tools. Each tool had an identified limitation. Current theory postulates a continuum between lymphedema and fibrosis, but only the Földi's Scale adequately reflected that concept. CONCLUSIONS: None of the available scales clearly captured all the important characteristics of external lymphedema in patients with HNC. A need exists to develop a clearly defined and validated scale of external lymphedema in the HNC population. IMPLICATIONS FOR NURSING: Oncology nurses should take an active role in addressing issues related to lymphedema assessment in patients post-HNC treatment; however, new assessment tools need to be developed for clinical use. KNOWLEDGE TRANSLATION: Early identification and accurate documentation of head and neck lymphedema are critically important to prevent lymphedema progress. However, existing grading criteria failed to capture important characteristics of external head and neck lymphedema. More research efforts need to be made to address this under-recognized issue.

Impact of secondary lymphedema after head and neck cancer treatment on symptoms, functional status, and quality of life.

BACKGROUND: Lymphedema may disrupt local function and affect quality of life (QOL) in patients with head and neck cancer. The purpose of this study was to examine the associations among severity of internal and external lymphedema, symptoms, functional status, and QOL in patients with head and neck cancer. METHODS: The sample included 103 patients who were ≥ 3 months after head and neck cancer treatment. Variables assessed included severity of internal and external lymphedema, physical/psychological symptoms, functional status, and QOL. RESULTS: Severity of internal and external lymphedema was associated with physical symptoms and psychological symptoms. Patients with more severe external lymphedema were more likely to have a decrease in neck left/right rotation. The combined effects of external and internal lymphedema severity were associated with hearing impairment and decreased QOL. CONCLUSIONS: Lymphedema severity correlates with symptom burden, functional status, and QOL in patients after head and neck cancer treatment.

Factors associated with external and internal lymphedema in patients with head-and-neck cancer.

PURPOSE: The purpose of this study was to examine factors associated with the presence of secondary external and internal lymphedema in patients with head-and-neck cancer (HNC). METHODS AND MATERIALS: The sample included 81 patients ≥3 months after HNC treatment. Physical and endoscopic examinations were conducted to determine if participants had external, internal, and/or combined head-and-neck lymphedema. Logistic regression analysis was used to examine the factors associated with the presence of lymphedema. RESULTS: The following factors were statistically significantly associated with presence of lymphedema: (1) location of tumor associated with presence of external (P=.009) and combined lymphedema (P=.032); (2) time since end of HNC treatment associated with presence of external (P=.004) and combined lymphedema (P=.005); (3) total dosage of radiation therapy (P=.010) and days of radiation (P=.017) associated with the presence of combined lymphedema; (4) radiation status of surgical bed was associated with the presence of internal lymphedema, including surgery with postoperative radiation (P=.030) and (salvage) surgery in the irradiated field (P=.008); and (5) number of treatment modalities associated with external (P=.002), internal (P=.039), and combined lymphedema (P=.004). No demographic, health behavior-related, or comorbidity factors were associated with the presence of lymphedema in the sample. CONCLUSIONS: Select tumor and treatment parameters are associated with increased occurrence of lymphedema in patients with HNC. Larger and longitudinal studies are needed to identify adjusted effects and causative risk factors contributing to the development of lymphedema in patients with HNC.

Expectations of pain and accompanying symptoms during cancer treatment.

Patients' experience of cancer pain varies throughout the course of the disease. It is important to recognize that patients may experience more than one type of pain, and pain often occurs in the presence of other symptoms. Controlling pain requires a multi-faceted approach to assessing and treating the underlying mechanisms. This article reviews the pain mechanisms responsible for pain during cancer treatment and how expectations of pain and associated symptoms contribute to the pain experience.

Vanderbilt Head and Neck Symptom Survey version 2.0: report of the development and initial testing of a subscale for assessment of oral health.

BACKGROUND: The prevalence, severity, and functional implications of adverse oral health outcomes attributed to head and neck cancer therapy are largely undefined. We report development of an oral health outcome subscale for the Vanderbilt Head and Neck Symptom Survey (VHNSS). METHODS: Oral health outcome questions were formulated through literature review and consultation with an expert panel. Questions were incorporated into the VHNSS resulting in a 50-item survey, scored 0 (none) to 10 (severe). The tool was administered to 70 subjects who completed radiation to assess for feasibility. RESULTS: Patient acceptance was high with a completion time <10 minutes. A full range of scores was noted for 46 of 50 questions. Oral health symptom burden was high early and late posttreatment. CONCLUSIONS: The VHNSS version 2.0 was feasible and could be completed in a timely manner. Validation studies are ongoing. The high prevalence of adverse oral health outcomes warrants further study.

Prevalence of secondary lymphedema in patients with head and neck cancer.

CONTEXT: Because surgery, radiation, and/or chemotherapy disrupt lymphatic structures, damage soft tissue leading to scar tissue formation and fibrosis, and further affect lymphatic function, patients with head and neck cancer may be at high risk for developing secondary lymphedema. Yet, no published data are available regarding the prevalence of secondary lymphedema after head and neck cancer treatment. OBJECTIVES: The aim of this study was to examine prevalence of secondary lymphedema in patients with head and neck cancer. METHODS: The study included 81 patients with head and neck cancer who were three months or more post-treatment. External lymphedema was staged using Foldi's lymphedema scale. Internal lymphedema was identified through a flexible fiber-optic endoscopic or mirror examination. Patterson's scale was used to grade degrees of internal lymphedema. RESULTS: Of the 81 patients, 75.3% (61 of 81) had some form of late-effect lymphedema. Of those, 9.8% (6 of 61) only had external, 39.4% (24 of 61) only had internal, and 50.8% (31 of 61) had both types. CONCLUSION: Lymphedema is a common late effect in patients with head and neck cancer, and it develops in multiple external and internal anatomical locations. During physical examination and endoscopic procedures, clinicians should assess patients with head and neck cancer for late-effect lymphedema. Referral for treatment should be considered when lymphedema is noted. Research is needed to examine risk factors of lymphedema in patients with head and neck cancer and its effects on patients' symptoms, function, and quality of life.