Dataset Information

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.

ABSTRACT: 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.

SUBMITTER: Graboyes EM

PROVIDER: S-EPMC10441452 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Graboyes Evan M EM Kistner-Griffin Emily E Hill Elizabeth G EG Maurer Stacey S Balliet Wendy W Williams Amy M AM Padgett Lynne L Yan Flora F Rush Angie A Johnson Brad B McLeod Taylor T Dahne Jennifer J Ruggiero Kenneth J KJ Sterba Katherine R KR

Research square 20230807

<b>Purpose:</b> 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. <b>Methods:</b> In this pilot randomized trial, HNC survivors with clinically signi ...[more]

PMID: 37609318

Similar Datasets

Project description:ImportanceAlthough 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.ObjectiveTo 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 participantsThis 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.InterventionsBRIGHT 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 measuresChange 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.ResultsOf 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 relevanceIn 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 registrationClinicalTrials.gov Identifier: NCT03831100.

Project description:BackgroundThe majority of breast cancer survivors (BCSs) experience body image concerns following treatment. Body Image distress (BID) is associated with psychological distress and diminished quality of life. A web-based self-compassion focused writing activity (My Changed Body - MyCB) reduces BID in BCSs, yet limited research exists on participant characteristics associated with such intervention adherence. Self-compassion-based meditations are also efficacious in reducing BID in non-BCS populations. This parallel, double-blind pilot randomised controlled trial aimed to assess the feasibility and acceptability of MyCB, with and without an additional meditation component, on BID and related psychological outcomes in BCSs. The trial was registered with the Australian and New Zealand Clinical Trials Registry (#ACTRN12619001693112).MethodsBCSs were randomly allocated to MyCB (n = 39), MyCB + Meditation (MyCB + M) (n = 17) or an expressive writing (EW) active control arm (n = 23). The primary outcome was BID. Secondary outcomes were body appreciation, affect (positive and negative), psychological distress (depression, anxiety and stress) and self-compassion (state and trait). Assessments were completed online at baseline, post-intervention and 1-month.ResultsAdherence to the MyCB writing (45%) and meditation (50%) was modest, and acceptability was high for both MyCB and MyCB + M. Intent to treat linear mixed model analyses indicated: Post-intervention - state self-compassion and positive affect increased for MyCB compared to EW; 1-month: BID scores decreased across all conditions; trait self-compassion increased and anxiety decreased for MyCB + M compared to MyCB and EW.ConclusionThese findings provide preliminary evidence for the efficacy and potential clinical use of the MyCB brief web-based self-compassion intervention alone and with the addition of meditation, to increase self-compassion and psychological wellbeing in BCSs.

Project description:ImportanceSocioeconomic deprivation is associated with increased risk of poor health and quality-of-life (QOL) outcomes in head and neck cancer (HNC) survivors. However, there are few data on how neighborhood deprivation affects patient-reported outcome measures (PROMs) in HNC survivors.ObjectiveTo investigate whether neighborhood socioeconomic deprivation is associated with symptom burden, psychological distress, and QOL among HNC survivors.Design, setting, and participantsThis cross-sectional study used prospectively collected data from patients seen in a university-affiliated multidisciplinary HNC survivorship clinic between September 2018 and September 2021 who received radiotherapy for squamous cell carcinoma of the oral cavity, oropharynx, and larynx or hypopharynx.ExposureNeighborhood socioeconomic deprivation, measured using the Area Deprivation Index (ADI).Main outcomes and measuresThe PROMs pertaining to symptom burden and severity of psychological distress were measured using the Neck Disability Index, Insomnia Severity Index, the 10-item Eating Assessment Tool, the Generalized Anxiety Disorder 7-item scale, and the 8-item Patient Health Questionnaire. Physical and social-emotional QOL were obtained using the University of Washington QOL questionnaire. Multivariable linear regression analysis adjusting for individual-level sociodemographic, comorbidity, and treatment characteristics investigated the association between ADI and PROMs. A subgroup analysis was performed to compare the lowest (most affluent areas: ADI, 0%-20%) and highest (most deprived areas: ADI, 80%-100%) ADI quintiles.ResultsA total of 277 patients were included in the final analysis (mean [SD] age, 64.18 [9.60] years; 215 [77.6%] male). Cancer sites were the oral cavity (52 [18.8%]), oropharyngeal area (171 [61.7%]), and larynx or hypopharynx (54 [19.5%]). Multivariable analysis showed that for every 1-point increase in ADI, social-emotional QOL changed by -0.14 points (95% CI, -0.24 to -0.05 points), anxiety increased by 0.03 points (95% CI, 0.01-0.06 points), and neck disability worsened by 0.05 points (95% CI, 0.01-0.10 points). Compared with patients in the most affluent areas, those in the most deprived areas had significantly lower physical (-15.89 points; 95% CI, -25.96 to -2.31 points; Cohen d = -0.83) and social-emotional (-13.57 points; 95% CI, -22.79 to -3.49 points; Cohen d = -0.69) QOL and higher depression (2.60 points; 95% CI, 0.21-4.40 points; Cohen d = 0.52), anxiety (3.12 points; 95% CI, 1.56-4.66 points; Cohen d = 0.61), insomnia (3.55 points; 95% CI, 0.33-6.41 points; Cohen d = 0.54), and neck disability (5.65 points; 95% CI, 1.66-9.55 points; Cohen d = 0.66) scores.Conclusions and relevanceIn this cross-sectional study, a higher ADI score was associated with higher risk of increased psychological distress, higher symptom burden, and decreased QOL after treatment among HNC survivors. These findings suggest that proactive, patient-centered interventions are needed to address these disparities.

Dataset Information

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.

Publications

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets