Evaluation of a novel telemedicine-based intervention to manage body image disturbance in head and neck cancer survivors.

OBJECTIVES: The study aimed to evaluate the feasibility, acceptability, and preliminary clinical impact of BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment), a novel telemedicine-based cognitive-behavioral intervention to manage body image disturbance (BID) in head and neck cancer (HNC) survivors. METHODS: Head and neck cancer survivors with BID were enrolled into a single-arm pilot trial. Participants completed study measures at baseline, 1- and 3-months post-BRIGHT to assess its acceptability and clinical impact. Participants completed semi-structured interviews to evaluate the feasibility and acceptability of BRIGHT and refine the intervention. RESULTS: Ten HNC survivors with BID were enrolled into the trial of tablet-based BRIGHT. BRIGHT was feasible, as judged by low dropout (n = 1), high session completion rates (100%; 45/45) and low rates of technical issues with the tablet-based delivery (11% minor; 0% major). Ninety percent of participants were highly likely to recommend BRIGHT, reflecting its acceptability. BRIGHT was associated with a 34.5% reduction in mean Body Image Scale scores at 1-month post-BRIGHT (mean difference from baseline = 4.56; 95% CI 1.55, 7.56), an effect that was durable at 3-months post-BRIGHT (mean decrease from baseline = 3.56; 95% CI 1.15-5.96). Program evaluation revealed high levels of satisfaction with BRIGHT, particularly the delivery platform. During the qualitative evaluation, participants highlighted that BRIGHT improved image-related coping behavior. CONCLUSIONS: BRIGHT is feasible, acceptable to HNC survivors, and has significant potential as a novel approach to manage BID in HNC survivors. Additional research is necessary to refine BRIGHT and evaluate its clinical efficacy and scalability.

Race and Prevalence of Large Bowel Polyps Among the Low-Income and Uninsured in South Carolina.

BACKGROUND: Compared to whites, blacks have higher colorectal cancer incidence and mortality rates and are at greater risk for early-onset disease. The reasons for this racial disparity are poorly understood, but one contributing factor could be differences in access to high-quality screening and medical care. AIMS: The present study was carried out to assess whether a racial difference in prevalence of large bowel polyps persists within a poor and uninsured population (n = 233, 124 blacks, 91 whites, 18 other) undergoing screening colonoscopy. METHODS: Eligible patients were uninsured, asymptomatic, had no personal history of colorectal neoplasia, and were between the ages 45-64 years (blacks) or 50-64 years (whites, other). We examined the prevalence of any adenoma (conventional, serrated) and then difference in adenoma/polyp type by race and age categories. RESULTS: Prevalence for ≥1 adenoma was 37 % (95 % CI 31-43 %) for all races combined and 36 % in blacks <50 years, 38 % in blacks ≥50 years, and 35 % in whites. When stratified by race, blacks had a higher prevalence of large conventional proximal neoplasia (8 %) compared to whites (2 %) (p value = 0.06) but a lower prevalence of any serrated-like (blacks 18 %, whites 32 %; p value = 0.02) and sessile serrated adenomas/polyps (blacks 2 %, whites 8 % Chi-square p value; p = 0.05). CONCLUSIONS: Within this uninsured population, the overall prevalence of adenomas was high and nearly equal by race, but the racial differences observed between serrated and conventional polyp types emphasize the importance of taking polyp type into account in future research on this topic.

Factors Associated With Risk of Body Image-Related Distress in Patients With Head and Neck Cancer.

Importance: Body image-related distress (BID) is common among head and neck cancer (HNC) survivors and associated with significant morbidity. Risk factors for HNC-related BID remain poorly characterized because prior research has used outcome measures that fail to fully capture BID as experienced by HNC survivors. Objective: To assess the association of demographic and oncologic characteristics with HNC-related BID using the Inventory to Measure and Assess imaGe disturbancE-Head & Neck (IMAGE-HN), a validated, multidomain, patient-reported outcome measure of HNC-related BID. Design, Setting, and Participants: This cross-sectional study assessed 301 adult survivors of surgically managed HNC at 4 academic medical centers. Main Outcomes and Measures: The primary outcome measure was IMAGE-HN scores, for which higher scores reflect more severe HNC-related BID. Multivariable linear regression analyses were performed to evaluate the association of patient characteristics with IMAGE-HN global and 4 subdomain (other-oriented appearance concerns, personal dissatisfaction with appearance, distress with functional impairments, and social avoidance) scores. Results: Of the 301 participants (212 [70.4%] male; mean [SD] age, 65.3 [11.7] years), 181 (60.1%) underwent free flap reconstruction. Graduation from college (ß = -9.6; 95% CI, -17.5 to -1.7) or graduate school (ß = -12.6; 95% CI, -21.2 to -3.8) was associated with lower IMAGE-HN social avoidance scores compared with less than a high school education. Compared with paid work, unemployment was associated with higher IMAGE-HN other-oriented appearance (ß = 10.7; 95% CI, 2.0-19.3), personal dissatisfaction with appearance (ß = 12.5; 95% CI, 1.2-23.7), and global (ß = 8.0; 95% CI, 0.6-15.4) scores. Compared with no reconstruction, free flap reconstruction was associated with higher IMAGE-HN global scores (ß = 11.5; 95% CI, 7.9-15.0) and all subdomain scores (other-oriented appearance: ß = 13.1; 95% CI, 8.6-17.6; personal dissatisfaction with appearance: ß = 15.4; 95% CI, 10.0-20.7; distress with functional impairment: ß = 12.8; 95% CI, 8.1-17.4; and social avoidance and isolation: ß = 10.2; 95% CI, 5.8-14.6). Higher IMAGE-HN distress with functional impairment scores were found in those who received surgery and adjuvant radiation (ß = 7.8; 95% CI, 2.9-12.7) or chemoradiotherapy (ß = 6.5; 95% CI, 1.8-11.3) compared with surgery alone. The multivariable regression model accounted for a modest proportion of variance in IMAGE-HN global (R2 = 0.18) and subdomain scores (R2 = 0.20 for other-oriented appearance, 0.14 for personal dissatisfaction with appearance, 0.21 for distress with functional impairment, and 0.13 for social avoidance and isolation). Conclusions and Relevance: In this cross-sectional study, factors associated with risk of HNC-related BID included free flap reconstruction, lower educational attainment, unemployment, and multiple treatment modalities. These characteristics explain a modest proportion of variance in IMAGE-HN scores, suggesting that other characteristics may be the major risk factors for HNC-related BID and should be explored in future studies.

Development and Evaluation of a Navigation-Based, Multilevel Intervention to Improve the Delivery of Timely, Guideline-Adherent Adjuvant Therapy for Patients With Head and Neck Cancer.

PURPOSE: More than half of patients with head and neck squamous cell carcinoma (HNSCC) experience a delay initiating guideline-adherent postoperative radiation therapy (PORT), contributing to excess mortality and racial disparities in survival. However, interventions to improve the delivery of timely, equitable PORT among patients with HNSCC are lacking. This study (1) describes the development of NDURE (Navigation for Disparities and Untimely Radiation thErapy), a navigation-based multilevel intervention (MLI) to improve guideline-adherent PORT and (2) evaluates its feasibility, acceptability, and preliminary efficacy. METHODS: NDURE was developed using the six steps of intervention mapping (IM). Subsequently, NDURE was evaluated by enrolling consecutive patients with locally advanced HNSCC undergoing surgery and PORT (n = 15) into a single-arm clinical trial with a mixed-methods approach to process evaluation. RESULTS: NDURE is a navigation-based MLI targeting barriers to timely, guideline-adherent PORT at the patient, healthcare team, and organizational levels. NDURE is delivered via three in-person navigation sessions anchored to case identification and surgical care transitions. Intervention components include the following: (1) patient education, (2) travel support, (3) a standardized process for initiating the discussion of expectations for PORT, (4) PORT care plans, (5) referral tracking and follow-up, and (6) organizational restructuring. NDURE was feasible, as judged by accrual (88% of eligible patients [100% Blacks] enrolled) and dropout (n = 0). One hundred percent of patients reported moderate or strong agreement that NDURE helped solve challenges starting PORT; 86% were highly likely to recommend NDURE. The rate of timely, guideline-adherent PORT was 86% overall and 100% for Black patients. CONCLUSION: NDURE is a navigation-based MLI that is feasible, is acceptable, and has the potential to improve the timely, equitable, guideline-adherent PORT.

Validation of a Novel, Multidomain Head and Neck Cancer Appearance- and Function-Distress Patient-Reported Outcome Measure.

OBJECTIVES: Distress with self-perceived changes in appearance and function can result in body image disturbance (BID), which is common in head and neck cancer (HNC) survivors and a major source of psychosocial morbidity. To address the lack of psychometrically sound patient-reported outcome measures (PROMs) of HNC-related BID, we aim to create and validate the Inventory to Measure and Assess imaGe disturbancE-Head & Neck (IMAGE-HN). STUDY DESIGN: Survey study. SETTING: Multiple academic centers. SUBJECTS AND METHODS: Following item development, HNC survivors from 4 academic centers completed the IMAGE-HN. Item responses were psychometrically analyzed using confirmatory factor analysis (CFA) and Rasch analysis. RESULTS: Item development resulted in a 31-item PROM consisting of 5 individual domains and a global domain. In total, 305 HNC survivors of diverse ages, HNC subsites, and reconstructive paradigms completed the initial items. After removal of 3 items for local dependence, CFA confirmed the unidimensionality and local independence (item residual correlations <|0.20|) for each domain. Rasch analysis indicated acceptable fit (infit and outfit mean squares <2.0), monotonicity of all rating scale categories, and low person misfit (<4%). Person separation indices and person reliability were adequate for each domain except appearance concealment, which was removed (4 items). This resulted in the IMAGE-HN, a psychometrically acceptable 24-item PROM of HNC-related BID consisting of a global scale and 4 subscales measuring unique constructs and comprised independent items. CONCLUSIONS: IMAGE-HN is a novel, psychometrically sound, multidomain PROM of HNC-related BID for use in clinical and research settings.

Temporal Trajectory of Body Image Disturbance in Patients with Surgically Treated Head and Neck Cancer.

OBJECTIVES: To characterize the temporal trajectory of body image disturbance (BID) in patients with surgically treated head and neck cancer (HNC). STUDY DESIGN: Prospective cohort study. SETTING: Academic medical center. SUBJECTS AND METHODS: Patients with HNC who were undergoing surgery completed the Body Image Scale (BIS), a validated patient-reported outcome measure of BID, pretreatment and 1, 3, 6, 9, and 12 months posttreatment. Changes in BIS scores (ΔBIS) relative to pretreatment (primary endpoint) were analyzed with a linear mixed model. Associations between demographics, clinical characteristics, psychosocial attributes, and persistently elevated BIS scores and increases in BIS scores ≥5 points relative to pretreatment (secondary endpoints) were analyzed through logistic regression. RESULTS: Of the 68 patients, most were male (n = 43), had oral cavity cancer (n = 37), and underwent microvascular reconstruction (n = 45). Relative to baseline, mean ΔBIS scores were elevated at 1 month postoperatively (2.9; 95% CI, 1.3-4.4) and 3 (3.2; 95% CI, 1.5-4.9) and 6 (1.8; 95% CI, 0.02-3.6) months posttreatment before returning to baseline at 9 months posttreatment (0.9; 95% CI, -0.8 to 2.5). Forty-three percent of patients (19 of 44) had persistently elevated BIS scores at 9 months posttreatment relative to baseline, and 51% (31 of 61) experienced an increase in BIS scores ≥5 relative to baseline. CONCLUSIONS: In this cohort of patients surgically treated for HNC, BID worsens posttreatment before returning to pretreatment (baseline) levels at 9 months posttreatment. However, 4 in 10 patients will experience a protracted course with persistent posttreatment body image concerns, and half will experience a significant increase in BIS scores relative to pretreatment levels.

Barriers to the Delivery of Timely, Guideline-Adherent Adjuvant Therapy Among Patients With Head and Neck Cancer.

PURPOSE: Delays initiating guideline-adherent postoperative radiation therapy (PORT) in head and neck squamous cell carcinoma (HNSCC) are common, contribute to excess mortality, and are a modifiable target for improving survival. However, the barriers that prevent the delivery of timely, guideline-adherent PORT remain unknown. This study aims to identify the multilevel barriers to timely, guideline-adherent PORT and organize them into a conceptual model. MATERIALS AND METHODS: Semi-structured interviews with key informants were conducted with a purposive sample of patients with HNSCC and oncology providers across diverse practice settings until thematic saturation (n = 45). Thematic analysis was performed to identify the themes that explain barriers to timely PORT and to develop a conceptual model. RESULTS: In all, 27 patients with HNSCC undergoing surgery and PORT were included, of whom 41% were African American, and 37% had surgery and PORT at different facilities. Eighteen clinicians representing a diverse mix of provider types from 7 oncology practices participated in key informant interviews. Five key themes representing barriers to timely PORT were identified across 5 health care delivery levels: (1) inadequate education about timely PORT, (2) postsurgical sequelae that interrupt the tight treatment timeline (both intrapersonal level), (3) insufficient coordination and communication during care transitions (interpersonal and health care team levels), (4) fragmentation of care across health care organizations (organizational level), and (5) travel burden for socioeconomically disadvantaged patients (community level). CONCLUSION: This study provides a novel description of the multilevel barriers that contribute to delayed PORT. Interventions targeting these multilevel barriers could improve the delivery of timely, guideline-adherent PORT and decrease mortality for patients with HNSCC.

Body Image Disturbance in Surgically Treated Head and Neck Cancer Patients: A Patient-Centered Approach.

OBJECTIVE: To promote patient-centered oncology care through an in-depth analysis of the patient experience of body image disturbance (BID) following surgery for head and neck cancer (HNC). STUDY DESIGN: Qualitative methods approach using semistructured key informant interviews. SETTING: Academic medical center. SUBJECTS AND METHODS: Participants with surgically treated HNC underwent semistructured key informant interviews and completed a sociodemographic survey. Recorded interviews were transcribed, coded, and analyzed using template analysis to inform creation of a conceptual model. RESULTS: Twenty-two participants with surgically treated HNC were included, of whom 16 had advanced stage disease and 15 underwent free tissue transfer. Five key themes emerged characterizing the participants' lived experiences with BID following HNC treatment: personal dissatisfaction with appearance, other-oriented appearance concerns, appearance concealment, distress with functional impairments, and social avoidance. The participant's perceived BID severity was modified by preoperative patient expectations, social support, and positive rational acceptance. These 5 key themes and 3 experiential modifiers form the basis of a novel, patient-centered conceptual model for understanding BID in HNC survivors. CONCLUSION: A patient-centered approach to HNC care reveals that dissatisfaction with appearance, other-oriented appearance concerns, appearance concealment, distress with functional impairments, and social avoidance are key conceptual domains characterizing HNC-related BID. Recognition of these psychosocial dimensions of BID in HNC patients can inform development of HNC-specific BID patient-reported outcome measures to facilitate quantitative assessment of BID as well as the development of novel preventative and therapeutic strategies for those at risk for, or suffering from, BID.

Body Image Disturbance in Surgically Treated Head and Neck Cancer Patients: A Prospective Cohort Pilot Study.

This prospective cohort pilot study sought to characterize the short-term temporal trajectory of, and risk factors for, body image disturbance (BID) in patients with head and neck cancer (HNC). Most patients were male (35/56), had oral cavity cancer (33/56), and underwent microvascular reconstruction (37/56). Using the Body Image Scale (BIS), a validated patient-reported outcome measure of BID, the prevalence of BID (BIS ≥10) increased from 11% preoperatively to 25% at 1 month postoperatively and 27% at 3 months posttreatment (P < .001 and P = .0014 relative to baseline, respectively). Risk factors for BID included female sex (odds ratio [OR], 4.8; 95% confidence interval [CI], 1.3-19.8), pT 3 to 4 tumors (OR, 8.9; 95% CI, 2.0-63.7), and more severe baseline shame and stigma (OR, 1.06; 95% CI, 1.01-1.13), depression (OR, 1.25; 95% CI, 1.06-1.51), and social isolation (OR, 1.21; 95% CI, 1.01-1.49). The prevalence and severity of BID increase immediately posttreatment. Demographic, oncologic, and psychosocial characteristics identify high-risk patients for targeted interventions.