Mechanism underlying a brief cognitive behavioral treatment for head and neck cancer survivors with body image distress.

PURPOSE: Body image distress (BID) among head and neck cancer (HNC) survivors is a debilitating toxicity associated with depression, anxiety, stigma, and poor quality of life. BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment) is a brief cognitive behavioral therapy (CBT) that reduces BID for these patients. This study examines the mechanism underlying BRIGHT. METHODS: In this randomized clinical trial, HNC survivors with clinically significant BID were randomized to receive five weekly psychologist-led video tele-CBT sessions (BRIGHT) or dose-and delivery matched survivorship education (attention control [AC]). Body image coping strategies, the hypothesized mediators, were assessed using the Body Image Coping Skills Inventory (BICSI). HNC-related BID was measured with the Inventory to Measure and Assess imaGe disturbancE-Head and Neck (IMAGE-HN). Causal mediation analyses were used to estimate the mediated effects of changes in BICSI scores on changes in IMAGE-HN scores. RESULTS: Among 44 HNC survivors with BID allocated to BRIGHT (n = 20) or AC (n = 24), mediation analyses showed that BRIGHT decreased avoidant body image coping (mean change in BICSI-Avoidance scale score) from baseline to 1-month post-intervention relative to AC (p = 0.039). Decreases in BICSI-Avoidance scores from baseline to 1-month resulted in decreases in IMAGE-HN scores from baseline to 3 months (p = 0.009). The effect of BRIGHT on IMAGE-HN scores at 3 months was partially mediated by a decrease in BICSI-Avoidance scores (p = 0.039). CONCLUSIONS: This randomized trial provides preliminary evidence that BRIGHT reduces BID among HNC survivors by decreasing avoidant body image coping. Further research is necessary to confirm these results and enhance the development of interventions targeting relevant pathways to reduce BID among HNC survivors. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03831100 .

Mechanism Underlying a Brief Cognitive Behavioral Treatment for Head and Neck Cancer Survivors with Body Image Distress.

Purpose: Body image distress (BID) among head and neck cancer (HNC) survivors is a debilitating toxicity associated with depression, anxiety, stigma, and poor quality of life. BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment) is a brief cognitive behavioral therapy (CBT) that reduces BID for these patients. This study examines the mechanism underlying BRIGHT. Methods: In this randomized clinical trial, HNC survivors with clinically significant BID were randomized to receive 5 weekly psychologist-led video tele-CBT sessions (BRIGHT) or dose-and delivery matched survivorship education (attention control [AC]). Body image coping strategies, the hypothesized mediators, were assessed using the Body Image Coping Skills Inventory (BICSI). HNC-related BID was measured with the IMAGE-HN. Causal mediation analyses were used to estimate the mediated effects of changes in BICSI scores on changes in IMAGE-HN scores. Results: Among 44 HNC survivors with BID, mediation analyses showed that BRIGHT decreased avoidant body image coping (mean change in BICSI-Avoidance scale score) from baseline to 1-month post-intervention relative to AC (p = 0.039). Decreases in BICSI-Avoidance scores from baseline to 1-month decreased IMAGE-HN scores from baseline to 3-months (p = 0.009). The effect of BRIGHT on IMAGE-HN scores at 3-months was partially mediated by a decrease in BICSI-Avoidance scores (p = 0.039). Conclusions: This randomized trial provides preliminary evidence that BRIGHT reduces BID among HNC survivors by decreasing avoidant body image coping. Further research is necessary to confirm these results and enhance the development of interventions targeting relevant pathways to reduce BID among HNC survivors. Trial Registration: This trial was registered on ClinicalTrials.gov identifier NCT03831100 on February 5, 2019.

Efficacy of a Brief Cognitive Behavioral Therapy for Head and Neck Cancer Survivors with Body Image Distress: Secondary Outcomes from the BRIGHT Pilot Randomized Clinical Trial.

Purpose: Body image distress (BID) among head and neck cancer (HNC) survivors leads to depression, social isolation, stigma, and poor quality of life. BRIGHT ( B uilding a R enewed I ma G e after H ead & neck cancer T reatment) is a brief, tailored cognitive behavioral therapy (CBT) that reduces HNC-related BID. This trial examines the effect of BRIGHT on psychosocial outcomes among HNC survivors with BID. Methods: In this pilot randomized trial, HNC survivors with clinically significant BID were randomized to 5 weekly psychologist-led tele-CBT sessions (BRIGHT) or dose-and delivery matched survivorship education (attention control [AC]). Secondary psychosocial outcomes were assessed using validated patient-reported outcomes at baseline and 1- and 3-months post-intervention. Results: Among 44 HNC survivors with BID, BRIGHT resulted in a greater reduction in depression relative to AC (mean model-based 1-month difference in Δ PROMIS SF v1.0-Depression 8a score, -3.4; 90% CI, -6.4 to -0.4; 3-month difference, -4.3; 90% CI, -7.8 to -0.8). BRIGHT also decreased shame and stigma relative to AC (mean model-based 3-month difference in Δ Shame and Stigma Scale score, -9.7; 90% CI, -15.2 to -4.2) and social isolation (mean model-based 3-month difference in Δ PROMIS SF v2.0 Social Isolation 8a score, -2.9; 90% CI, -5.8 to -0.1). Conclusions: In this planned secondary analysis of a pilot RCT, BRIGHT improved a broad array of psychosocial outcomes among HNC survivors with BID. Implications for Cancer Survivors: These promising preliminary data suggest the need for a large efficacy trial evaluating the effect of BRIGHT on psychosocial outcomes among HNC survivors with BID. Trial Registration: ClinicalTrials.gov identifier: NCT03831100.

Efficacy of a brief cognitive behavioral therapy for head and neck cancer survivors with body image distress: secondary outcomes from the BRIGHT pilot randomized clinical trial.

PURPOSE: Body image distress (BID) among head and neck cancer (HNC) survivors leads to depression, social isolation, stigma, and poor quality of life. BRIGHT (Building a Renewed ImaGe after Head and neck cancer Treatment) is a brief, tailored cognitive behavioral therapy (CBT) that reduces HNC-related BID. This trial examines the effect of BRIGHT on psychosocial outcomes among HNC survivors with BID. METHODS: In this pilot randomized trial, HNC survivors with clinically significant BID were randomized to 5 weekly psychologist-led tele-CBT sessions (BRIGHT) or dose and delivery-matched survivorship education (attention control [AC]). Secondary psychosocial outcomes were assessed using validated patient-reported outcomes at baseline and 1 and 3-month post-intervention. RESULTS: Among 44 HNC survivors with BID, BRIGHT resulted in a greater reduction in depression relative to AC (mean model-based 1-month difference in Δ PROMIS SF v1.0-Depression 8a score, -3.4; 90% CI, -6.4 to -0.4; 3-month difference, -4.3; 90% CI, -7.8 to -0.8). BRIGHT also decreased shame and stigma relative to AC (mean model-based 3-month difference in Δ Shame and Stigma Scale score, -9.7; 90% CI, -15.2 to -4.2) and social isolation (mean model-based 3-month difference in Δ PROMIS SF v2.0 Social Isolation 8a score, -2.9; 90% CI, -5.8 to -0.1). CONCLUSIONS: In this planned secondary analysis of a pilot RCT, BRIGHT improved a broad array of psychosocial outcomes among HNC survivors with BID. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03831100 . IMPLICATIONS FOR CANCER SURVIVORS: These promising preliminary data suggest the need for a large efficacy trial evaluating the effect of BRIGHT on psychosocial outcomes among HNC survivors with BID.

Efficacy of a Brief Tele-Cognitive Behavioral Treatment vs Attention Control for Head and Neck Cancer Survivors With Body Image Distress: A Pilot Randomized Clinical Trial.

Importance: Although 1 in 4 head and neck cancer (HNC) survivors experience clinically significant body image distress (BID), a psychosocial morbidity that adversely affects quality of life, effective interventions for these patients are lacking. Objective: To evaluate the acceptability and preliminary efficacy of BRIGHT (Building a Renewed ImaGe after Head and neck cancer Treatment), a brief tele-cognitive behavioral therapy, at reducing BID among HNC survivors. Design, Setting, and Participants: This parallel-group pilot randomized clinical trial recruited adult HNC survivors with BID between August 13, 2020, and December 9, 2021, from the Medical University of South Carolina HNC clinic during a routine survivorship encounter. Data were analyzed from May 3 to June 16, 2022. Interventions: BRIGHT consisted of 5 weekly psychologist-led video tele-cognitive behavioral therapy sessions. Attention control (AC) consisted of dose- and delivery-matched survivorship education. Main Outcomes and Measures: Change in HNC-related BID was assessed using IMAGE-HN (Inventory to Measure and Assess imaGe disturbancE-Head and Neck), a validated patient-reported outcome (score range, 0-84, with higher scores indicating greater HNC-related BID). Clinical response rate was measured as the proportion of patients with a clinically meaningful change in IMAGE-HN scores. Results: Of the 44 HNC survivors with BID allocated to BRIGHT (n = 20) or AC (n = 24), the median (range) age was 63 (41-80) years, and 27 patients (61%) were female. Patients rated BRIGHT's acceptability highly (all metrics had a mean rating of ≥4.5/5), and 19 of 20 patients (95%) receiving BRIGHT were likely or highly likely to recommend it to other HNC survivors with BID. BRIGHT decreased HNC-related BID from baseline to 1 month postintervention relative to AC (mean model-based difference in change in IMAGE-HN score, -7.9 points; 90% CI, -15.9 to 0.0 points) and from baseline to 3 months postintervention relative to AC (mean model-based difference in change in IMAGE-HN score, -17.1 points; 90% CI, -25.6 to -8.6 points). At 3 months postintervention, the clinical response rate of BRIGHT was 6.6-fold higher than AC (model-based odds ratio, 6.6; 90% CI, 2.0-21.8). The improvement in HNC-related BID for BRIGHT vs AC at 3 months was clinically significant, and the effect size was large (Cohen d, -0.9; 90% CI, -1.4 to -0.4). Conclusions and Relevance: In this pilot randomized clinical trial, BRIGHT was acceptable, may result in a clinically meaningful improvement in HNC-related BID, and showed a high clinical response rate. These promising preliminary data support conducting a large efficacy trial to establish BRIGHT as the first evidence-based treatment for HNC survivors with BID. Trial Registration: ClinicalTrials.gov Identifier: NCT03831100.

Association of Inventory to Measure and Assess imaGe Disturbance - Head and Neck Scores With Clinically Meaningful Body Image-Related Distress Among Head and Neck Cancer Survivors.

Objective: The Inventory to Measure and Assess imaGe disturbance - Head and Neck (IMAGE-HN) is a validated patient-reported outcome measure of head and neck cancer-related body image-related distress (BID). However, the IMAGE-HN score corresponding to clinically relevant BID is unknown. The study objective is to determine the IMAGE-HN cutoff score that identifies head and neck cancer patients with clinically relevant BID. Methods: We conducted a cross-sectional study at six academic medical centers. Individuals ≥18 years old with a history of head and neck cancer treated with definitive intent were included. The primary outcome measure was the IMAGE-HN. A Receiver Operating Characteristic curve analysis was performed to identify the IMAGE-HN score that maximized sensitivity and specificity relative to a Body Image Scale score of ≥10 (which indicates clinically relevant BID in a general oncology population). To confirm the validity of the IMAGE-HN cutoff score, we compared the severity of depressive [Patient Health Questionnaire-9 (PHQ-9)] and anxiety symptoms [Generalized Anxiety Disorder-7 (GAD-7)], and quality of life [University of Washington-QOL (UW-QOL)] in patients with IMAGE-HN scores above and below the cutoff. Results: Of the 250 patients, 70.4% were male and the mean age was 62.3 years. An IMAGE-HN score of ≥22 was the optimal cutoff score relative to a Body Image Scale score of ≥10 and represents a clinically relevant level of head and neck cancer-related BID. Relative to those with an IMAGE-HN score of <22, patients with IMAGE-HN scores of ≥22 had a clinically meaningful increase in symptoms of depression (mean PHQ-9 score difference = 5.8) and anxiety (mean GAD-7 score difference = 4.1) as well as worse physical (mean UW-QOL score difference = 18.9) and social-emotional QOL (mean UW-QOL score difference = 21.5). Using an IMAGE-HN cutoff score ≥22, 28% of patients had clinically relevant BID. Conclusion: An IMAGE-HN score of ≥22 identifies patients with clinically relevant head and neck cancer-related BID. This score may be used to detect patients who could benefit from strategies to manage their distress, select patients for studies evaluating interventions to manage head and neck cancer-related BID, and improve our understanding of the underlying epidemiology of the disorder.

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.

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.

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.

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.

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.

A Systematic Review of Patient-Reported Outcome Measures Assessing Body Image Disturbance in Patients with Head and Neck Cancer.

OBJECTIVE: To synthesize published literature describing the severity of body image disturbance (BID) in patients with head and neck cancer (HNC) over time, its psychosocial and functional associations, and treatment strategies as assessed by patient-reported outcome measures (PROMs). DATA SOURCE: PubMed/MEDLINE, Scopus, PsycINFO, Web of Science, and Google Scholar. REVIEW METHODS: A systematic review of the English-language literature was performed to identify studies of BID in patients with HNC using psychometrically validated PROMs to assess (1) severity of BID over time, (2) psychosocial and functional associations, and (3) management strategies. RESULTS: A total of 17 studies met inclusion criteria. BID was assessed via 10 different PROMs, none of which were HNC-specific measures of BID. Two of 2 longitudinal studies (100%) reported that BID improved from pretreatment to posttreatment, and 2 of 3 longitudinal studies (67%) showed that the severity of BID decreased over time as survivors got further out from treatment. Seven of 17 studies (41%) described negative functional and psychosocial associations with BID, although study methodology limited conclusions about cause and effect. None of the studies assessing interventions to manage BID (0/2, 0%) demonstrated an improvement in BID relative to control. CONCLUSION: BID in patients with HNC has negative functional and psychosocial associations and lacks evidence-based treatment. Research is limited by the lack of an HNC-specific BID PROM. Further research should address knowledge gaps related to the lack of an HNC-specific BID PROM, longitudinal course of BID in patients with HNC, confusion with regards to risk factors and outcomes, and lack of prevention and treatment strategies.