This planned analysis of secondary outcomes of a pilot RCT aimed to elucidate the effect of BRIGHT, a brief tailored CBT, on a broad array of psychosocial outcomes among HNC survivors with BID. Herein we report preliminary data suggesting that BRIGHT reduces depression, shame and stigma and social isolation, and improves satisfaction with social roles and activities among HNC survivors with BID relative to AC. For each psychosocial outcome measure improved by BRIGHT, we also show that the beneficial effects of BRIGHT are realized by most patients and that the responses are relatively durable, with sustained and even increased improvement at 3-months post-intervention. When considered in conjunction with the primary outcome data from this pilot RCT,20 the findings of this current study add to the growing evidence base supporting BRIGHT as a novel, evidence-based strategy to manage BID among HNC survivors.
Depression, although common among HNC survivors,1,15 is especially prevalent among HNC survivors with BID.34 One recent study reported that HNC survivors with clinically significant BID had a 6-fold increase in moderate to severe depressive symptoms relative to HNC survivors without BID.10 Among HNC survivors, depression is associated with reduced QOL,35 higher rates of suicide,36 and worse overall survival.37 When considering trials evaluating the effectiveness of interventions targeting BID among HNC survivors, the effect on depression is thus a critically important endpoint. In this pilot trial, BRIGHT resulted in a statistically significant reduction in depressive symptoms at 1- and 3-months post-intervention. The effect of BID-focused interventions on depression in other trials have had mixed results. For example, a self-compassion based intervention did not improve depression among HNC survivors with BID in a single-arm pre-post study,38 whereas a skin camouflage program did improve depression relative to control.39 In two other recent trials evaluating interventions to reduce BID among HNC survivors, depression was not evaluated as an endpoint.18,40 The reasons for the different observed effect of BID-focused interventions on depression amongst these trials is not known but may relate to the efficacy of the intervention on the targeted outcome (BID), with BRIGHT showing the largest improvement in BID in this population. Whatever the explanation, it is clear that (1) future studies should include depression as a secondary endpoint and (2) these preliminary data suggest that BRIGHT, in addition to reducing HNC-related BID, may also improve a key psychosocial outcome in these patients.
When interpreting the findings from the current trial, it is important to consider the unclear causal and temporal relationship between depression, BID, and QOL. CBT is an effective treatment for depression among cancer survivors and one of the recommended 1st line therapies for cancer survivors with moderate depression.41,42 Thus, one possible interpretation of our findings is that BRIGHT caused a reduction in depression primarily, and the observed improvement in BID is causally downstream of the improvement in depression. It is also possible that there is a bidirectional relationship between depression and BID in which reductions in one results in further reductions in the other. Finally, a third potential interpretation of these data is that BRIGHT improves BID primarily and the reduction in depression is downstream. Although the current study design precludes definitively evaluating the temporal relationship between changes in BID and changes in depression following BRIGHT, we believe this third interpretation is the most likely for two reasons. First, the content and psychotherapeutic techniques of the BRIGHT program focus exclusively on domains related to HNC BID-related and are thus unlikely to be sufficiently therapeutically active to see an improvement in depressive symptoms of this magnitude due to direct effects on depression. Second, limited data from two prospective cohort studies suggest that pre-treatment depression is not a risk factor for HNC-related BID, that BID develops temporally prior to depression in patients for whom the conditions co-occur.13,43 Additional research is therefore necessary to disentangle the temporal relationship between changes in depression and BID among HNC survivors following BRIGHT.
Shame, stigma, and social isolation are all important, if understudied, psychosocial outcomes for HNC survivors.12 Although common among all HNC survivors, shame and stigma-related concerns are especially prevalent among HNC survivors with disfigurement and other visible differences.6 Patients with facial disfigurement and BID limit social interaction and participation in social functions.44,45 BID among HNC survivors is also associated with unemployment.10 Outside the context of psychosocial oncology, shame and stigma have significant effects on social, family, and professional relationships. Although they are not universally included,18,38,40 shame, stigma, and social isolation are all key secondary endpoints for trials evaluating interventions to improve BID among HNC survivors. In this pilot trial, we provide preliminary evidence that BRIGHT reduces HNC-related shame and stigma, decreases social isolation, and improves satisfaction with social roles and activities among HNC survivors with BID. Our data align with other studies which have observed similar benefits of BID-focused interventions on outcomes of social avoidance and fear of social interactions.39 These preliminary data suggest that managing BID among HNC survivors with BID through interventions such as BRIGHT may thus contribute to improvements in performance in key social domains. As with depression, the inter-relationship and causal dependency of BID with each of these constructs (and with each of these constructs with one another) is complex. However, based on current conceptual models of HNC-related BID, it is likely that the effect of BRIGHT on shame and stigma, social isolation, and social activities is downstream of its effect on HNC-related BID.
Limitations
As discussed in the publication of the primary outcomes for this pilot RCT, findings should be interpreted within the context of several trial limitations. Consistent with its pilot objective, the trial had a single-site design, small sample size, and short follow-up.20 With regard to the limitations of the specific secondary outcomes analyzed herein, the study was not powered for these outcomes, nor was it powered for more complex analyses that examined the relative associations of BID and depression to quality of life. Therefore, these planned secondary analyses should be considered hypothesis-generating and require confirmation in a larger trial. In addition, the clinical significance of the statistically significant improvements in measures of shame and stigma, depression, social isolation, and satisfaction with social roles and activities is not known. Therefore, further psychometric work is necessary to understand clinically meaningful differences in these measures over time and between groups within this patient population. Finally, although the trial was designed prior to the COVID-19 pandemic, it was conducted primarily during the pandemic when masking and social isolation were recommended public health measures. As a result, the external validity of study findings about the effect of BRIGHT on depression, anxiety, social isolation, and satisfaction with social activities outside the context of COVID-19 related masking (which effectively conceals many facial disfigurements associated with HNC treatment) and social avoidance public health measures is unknown and thus requires further study.