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PURPOSE: Adjuvant endocrine therapy (AET) is a life-saving medication for patients with hormone-sensitive breast cancer, yet many struggle with adherence, warranting behavioral intervention. In our recent trial, participation in a group cognitive behavioral intervention (STRIDE) for symptom management and adherence was associated with improvements in symptom distress, coping, quality of life, and mood. We now explore whether baseline patient- and medication-specific factors-which may be modifiable by clinician-led discussions-moderated the effect of STRIDE on adherence rates. METHODS: From October 2019 to June 2021, 100 patients with early-stage breast cancer reporting AET-related distress were enrolled and randomly assigned to STRIDE or a medication monitoring (MM) control group. All patients stored their AET in electronic pill bottles to track objective adherence. Patients also self-reported their adherence on the Medication Adherence Report Scale-5 and their perceptions of AET on the Cancer Therapy Satisfaction Questionnaire at baseline. We conducted hierarchical linear modeling to test moderators of intervention effects on objective adherence rates. We report the time × group × moderator effects. RESULTS: Among patients reporting greater perceived difficulties with AET adherence at baseline, STRIDE participants had higher adherence rates over time compared with MM (b = -13.80; SE = 4.56; P < .01). Patients with greater expectations of therapeutic benefit from AET also had improved adherence rates if they were assigned to STRIDE, versus MM (b = 0.25; SE = 0.10; P = .01). Patients who perceived taking AET as convenient and had been taking their AET for less time had higher adherence rates in STRIDE, versus MM. CONCLUSION: The current study identified patient- and medication-specific factors that may augment AET adherence interventions and may be modifiable through clinician-led discussions, such as perceptions of adherence problems, therapeutic efficacy, and convenience of AET.
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Gut-microbiota modulation shows promise in improving immune-checkpoint blockade (ICB) response; however, precision biomarker-driven, placebo-controlled trials are lacking. We performed a multicenter, randomized placebo-controlled, biomarker-stratified phase I trial in patients with ICB-naïve metastatic melanoma using SER-401, an orally delivered Firmicutesenriched spore formulation. Fecal microbiota signatures were characterized at baseline; patients were stratified by high versus low Ruminococcaceae abundance prior to randomization to the SER-401 arm (oral vancomycin-preconditioning/SER-401 alone/nivolumab + SER-401), versus the placebo arm [placebo antibiotic/placebo microbiome modulation (PMM)/nivolumab + PMM (NCT03817125)]. Analysis of 14 accrued patients demonstrated that treatment with SER-401 + nivolumab was safe, with an overall response rate of 25% in the SER-401 arm and 67% in the placebo arm (though the study was underpowered related to poor accrual during the COVID-19 pandemic). Translational analyses demonstrated that vancomycin preconditioning was associated with the disruption of the gut microbiota and impaired immunity, with incomplete recovery at ICB administration (particularly in patients with high baseline Ruminococcaceae). These results have important implications for future microbiome modulation trials. Significance: This first-of-its-kind, placebo-controlled, randomized biomarker-driven microbiome modulation trial demonstrated that vancomycin + SER-401 and anti-PD-1 are safe in melanoma patients. Although limited by poor accrual during the pandemic, important insights were gained via translational analyses, suggesting that antibiotic preconditioning and interventional drug dosing regimens should be carefully considered when designing such trials.
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Antibacterianos , Microbioma Gastrointestinal , Melanoma , Humanos , Melanoma/tratamento farmacológico , Microbioma Gastrointestinal/efeitos dos fármacos , Antibacterianos/uso terapêutico , Antibacterianos/farmacologia , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Inibidores de Checkpoint Imunológico/uso terapêutico , Nivolumabe/uso terapêutico , Nivolumabe/administração & dosagem , Biomarcadores Tumorais , Vancomicina/uso terapêutico , Adulto , COVID-19/imunologia , Neoplasias Cutâneas/tratamento farmacológico , Neoplasias Cutâneas/imunologiaRESUMO
BACKGROUND: Familism, the cultural value that emphasizes feelings of loyalty and dedication to one's family, has been related to both positive and negative outcomes in Hispanic cancer survivors. One potential source of observed inconsistencies may be limited attention to the family environment, as familism may be protective in a cohesive family whereas it can exacerbate distress in a conflictive family. PURPOSE: The current study explored the associations of familism with general and disease-specific health-related quality of life (HRQoL) in Hispanic men who completed prostate cancer (PC) treatment, and whether family cohesion may help explain these relationships. METHODS: Hispanic men treated for localized PC (e.g., radiation, surgery) were enrolled in a randomized controlled stress management trial and assessed prior to randomization. Familism (familial obligation) was assessed using Sabogal's Familism Scale and family cohesion was measured using the Family Environment Scale (ranging from high to low). The sexual, urinary incontinence, and urinary obstructive/irritative domains of the Expanded Prostate Cancer Index Composite - Short Form measured disease-specific HRQoL. The physical, emotional, and functional well-being subscales of the Functional Assessment of Cancer Therapy - General captured general HRQoL. Hierarchical linear regression and the SPSS PROCESS macro were used to conduct moderation analyses, while controlling for relevant covariates. RESULTS: Participants were 202 older men on average 65.7 years of age (SD = 8.0) who had been diagnosed with PC an average of 22 months prior to enrollment. Familism was not directly associated with general and disease-specific HRQoL. Moderation analyses revealed that greater familism was related to poorer urinary functioning in the incontinence (p = .03) and irritative/obstructive domains (p = .01), and lower emotional well-being (p = .02), particularly when family cohesion was low. CONCLUSIONS: These findings underscore the importance of considering contextual factors, such as family cohesion, in understanding the influence of familism on general and disease-specific HRQoL among Hispanic PC patients. The combined influence of familism and family cohesion predicts clinically meaningful differences in urinary functioning and emotional well-being during the posttreatment phase. Culturally sensitive psychosocial interventions to boost family cohesion and leverage the positive impact of familistic attitudes are needed to enhance HRQoL outcomes in this population.
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Sobreviventes de Câncer , Relações Familiares , Hispânico ou Latino , Neoplasias da Próstata , Qualidade de Vida , Humanos , Masculino , Qualidade de Vida/psicologia , Neoplasias da Próstata/psicologia , Neoplasias da Próstata/etnologia , Neoplasias da Próstata/terapia , Hispânico ou Latino/psicologia , Sobreviventes de Câncer/psicologia , Pessoa de Meia-Idade , Idoso , Relações Familiares/psicologia , Relações Familiares/etnologia , Família/psicologiaRESUMO
PURPOSE: Adjuvant endocrine therapy (AET) reduces breast cancer morbidity and mortality, yet women often report suboptimal adherence. Though correlates of AET adherence are well-documented, few studies examine the relative importance of multi-level factors associated with adherence. The aim of this study was to identify factors most strongly associated with AET adherence in women with breast cancer. METHODS: Between 10/2019 and 6/2021, women (N = 100) with non-metastatic, hormone receptor-positive breast cancer, taking AET who reported AET-related distress enrolled into a clinical trial. Participants completed baseline measures, including the Medication Adherence Rating Scale-5, sociodemographics, and validated measures of anxiety, depression, medication-taking self-efficacy, social support, and treatment satisfaction. We created a latent factor and tested associations between sociodemographic, medical, and psychosocial characteristics and adherence. Associated predictors (p < .10) were entered into a structural model, which was corroborated via multivariate regression modeling. RESULTS: A four-indicator latent adherence factor demonstrated good model fit. Participants (Mage = 56.1 years, 91% White) who were unemployed (B = 0.27, SE = 0.13, p = .046) and reported greater treatment convenience (B = 0.01, SE = 0.01, p = .046) reported greater adherence. Scores of participants who reported greater medication-taking self-efficacy (p = .097) and social support (p = .062) approached better adherence. Greater medication-taking self-efficacy (B = 0.08, SE = 0.02, p < .001) and being unemployed (B = 0.28, SE = .14, p = .042) were most strongly associated with greater adherence, independent of other predictors. Multivariate modeling confirmed similar findings. CONCLUSIONS: Medication-taking self-efficacy and employment status were associated with AET adherence above other related factors. IMPLICATIONS FOR CANCER SURVIVORS: Enhancing patients' confidence in their ability to take AET for breast cancer may represent an important intervention target to boost adherence.
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PURPOSE: Adjuvant endocrine therapy (AET) reduces breast cancer morbidity and mortality; however, adherence is suboptimal. Interventions exist, yet few have improved adherence. Patient characteristics may alter uptake of an intervention to boost adherence. We examined moderators of the effect of a virtual intervention (STRIDE; #NCT03837496) on AET adherence after breast cancer. METHODS: At a large academic medical center, patients taking AET (N = 100; Mage = 56.1, 91% White) were randomized to receive STRIDE versus medication monitoring. All stored their medication in digital pill bottles (MEMS Caps) which captured objective adherence. Participants self-reported adherence (Medication Adherence Report Scale) at 12 weeks post-baseline. Moderators included age, anxiety, and depressive symptoms (Hospital Anxiety and Depression Scale), AET-related symptom distress (Breast Cancer Prevention Trial Symptom Scale), and AET-specific concerns (Beliefs about Medications Questionnaire). We used hierarchical linear modeling (time × condition × moderator) and multiple regression (condition × moderator) to test the interaction effects on adherence. RESULTS: Age (B = 0.05, SE = 0.02, p = 0.003) and AET-related symptom distress (B = -0.04, SE = 0.02, p = 0.02) moderated condition effect on self-reported adherence while anxiety (B = -1.20, SE = 0.53, p = 0.03) and depressive symptoms (B = -1.65, SE = 0.65, p = 0.01) moderated objective adherence effects. AET-specific concerns approached significance (B = 0.91, SE = 0.57, p = 0.12). Participants who received STRIDE and were older or presented with lower anxiety and depressive symptoms or AET-related symptom distress exhibited improved adherence. Post hoc analyses revealed high correlations among most moderators. CONCLUSIONS: A subgroup of patients who received STRIDE exhibited improvements in AET adherence. The interrelatedness of moderators suggests an underlying profile of patients with lower symptom burden who benefitted most from the intervention. STUDY REGISTRATION: NCT03837496.
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Neoplasias da Mama , Humanos , Pessoa de Meia-Idade , Feminino , Quimioterapia Adjuvante/efeitos adversos , Antineoplásicos Hormonais/efeitos adversos , Adesão à Medicação , Inquéritos e QuestionáriosRESUMO
Burgeoning technologies and the COVID-19 pandemic resulted in a boom of telehealth for immunocompromised patients, such as those with cancer. Telehealth modalities overcome barriers and promote accessibility to care. Currently, efficacious psychosocial interventions exist to address negative aftereffects of a cancer diagnosis and treatment. Many of these interventions often incorporate asynchronous telehealth (e.g., web-based, smartphone mobile app) features. However, asynchronous platforms are limited by suboptimal engagement. Subjective indicators of perceived engagement in the forms of acceptability, feasibility, and adherence are often captured, yet prior research has found discrepancies between perceived and actual engagement. The FITT (frequency, intensity, time/duration, type of engagement) model, originally developed for use to quantify engagement within exercise trials, provides a framework to assess objective engagement of psychosocial interventions for breast cancer. Using 14 keywords and searching six databases through 11/2023, 56 studies that used asynchronous telehealth interventions in breast cancer were identified. All FITT domains were reported at least once across studies with intensity metrics most commonly reported. Nine metrics were described across FITT domains. Human-centered design principles to guide telehealth development and privacy considerations are discussed. Findings offer suggestions for how to represent and optimize objective engagement in asynchronous telehealth cancer care.
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Neoplasias da Mama , Sobreviventes de Câncer , Telemedicina , Humanos , Feminino , Neoplasias da Mama/terapia , Pandemias , Intervenção Psicossocial , Telemedicina/métodosRESUMO
Objective: Despite more women living with metastatic breast cancer (MBC), this population is underrepresented in cancer survivorship research. Few studies have assessed how women with MBC cope with their cancer experience. This qualitative study describes the coping strategies and psychosocial resources utilized by women living with MBC.Methods: Twenty-two women with MBC participated in four focus groups. Transcripts were analyzed using a general inductive approach. Codes derived from participants' responses were subsequently condensed into themes.Results: We identified 12 coping strategies and psychosocial resources and grouped them into five themes: Behavioral Coping Strategies (i.e. stress management, active coping and planning); Cognitive Coping Strategies and Psychological Resources (i.e. cognitive reappraisal, optimism, mindfulness, positive thinking, and religious coping); Existential Approach-Oriented Coping (i.e. acceptance, values-based living, and identity integration); Avoidance (i.e. avoidant coping); and Interpersonal Resources and Seeking Social Support (i.e. social support).Conclusions: Women living with MBC utilize several engagement and disengagement coping strategies, as well as intrapersonal and interpersonal resources. This study provides useful perspectives of women living with MBC that may inform the development of psychosocial interventions. Further research is needed to assess coping strategies and psychosocial resources across different subgroups of MBC patients and determine their impact on cancer outcomes.
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PURPOSE: Digital interventions, like websites, offer greater access to psychosocial treatments; however, engagement is often suboptimal. Initial use may be a target to "hook" participants. Few studies examine engagement with cognitive behavioral stress management (CBSM). We tested predictors of engagement in the first week of using a CBSM website among women with breast cancer (BC). METHODS: Older women (≥ 50 years) with nonmetastatic BC enrolled in an on-going trial (8/2016-4/2022, #NCT03955991) and were randomized to receive 10 synchronous, virtual CBSM group sessions immediately (n = 41) or after a 6-month waitlist (n = 34). All received simultaneous access to an asynchronous website, where supplemental videos and resources were released weekly. Engagement was tracked via breadth (features used) and depth (clicks within content). Multilevel modeling tested predictors of engagement (i.e., time, condition, age, daily stress, depression, race, ethnicity, disease stage). RESULTS: Breadth decreased over the first week of CBSM (b = -0.93, p < .01), and women with more advanced stage disease engaged with more breadth (b = 0.52, p < .01) and depth (b = 14.06, p < .01) than women with earlier stage disease. Non-Hispanic (b = -0.59, p = .03) and White (b = -0.97, p < .01) women engaged with more features. Cancer stage and intervention timing interacted. Women with more advanced cancer stage who received CBSM later engaged with the most depth (b = -11.73, p = .04). All other characteristics did not predict engagement. CONCLUSIONS: Disease stage, race, ethnicity, and intervention timing predicted engagement with a CBSM website in older BC patients. IMPLICATIONS FOR CANCER SURVIVORS: Delivering CBSM later in cancer treatment may mitigate competing demands. Fostering greater engagement in racial/ethnic minorities is needed.
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Neoplasias da Mama , Terapia Cognitivo-Comportamental , Humanos , Feminino , Idoso , Neoplasias da Mama/terapia , Neoplasias da Mama/psicologia , Estresse Psicológico/etiologia , Estresse Psicológico/terapia , Estresse Psicológico/psicologia , Psicoterapia , CogniçãoRESUMO
PURPOSE: Identifying clinically relevant comorbidities and their effect on health-related quality of life (HRQoL) outcomes among men with advanced prostate cancer (APC) can inform patient care and improve outcomes; however, this is poorly understood. The aim of this observational study was to examine the prevalence of comorbidities, and the relationship of comorbidity burden to HRQoL and other patient-reported outcomes (PROs) among men with APC. METHODS: Participants were 192 men (average age 68.8) with APC (stage III or IV) who completed a psychosocial battery including measures of sociodemographic factors, HRQoL and other PROs, and the Charlson Comorbidity Index (CCI). Hierarchical multiple regression analysis was used to examine the relationships between CCI, HRQOL, and PROs. RESULTS: The vast majority (82%) of participants had at least one comorbidity, with the most common being: hypertension (59%), connective tissue disease or arthritis (31%), diabetes (24%), and problems with kidneys, vision, or another organ (24%). After controlling for covariates, regressions showed that a higher CCI score was significantly associated with worse HRQoL (p < 0.001), lower levels of positive affect (p < 0.05), and higher levels of depression (p < 0.05), fatigue (p < 0.001), pain (p < 0.01), stress (p < 0.01), and cancer-specific distress (p < 0.05). CONCLUSIONS: Comorbidities were common among men with APC, and a greater CCI score was associated with detriments in several domains of HRQoL and other PROs. Our findings show the need to address comorbidities in the presence of a cancer diagnosis and subsequent treatment. TRIAL REGISTRATION CLINICALTRIALS. GOV IDENTIFIER: NCT03149185.
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Diabetes Mellitus , Hipertensão , Neoplasias da Próstata , Masculino , Humanos , Idoso , Qualidade de Vida , Comorbidade , Neoplasias da Próstata/terapia , Diabetes Mellitus/epidemiologiaRESUMO
Evidence suggests social media use is strongly linked to disordered eating (e.g., binge eating and dietary restraint) among adolescent and young adult women, in part because it promotes engagement in social comparison (the tendency to evaluate one's own standing or ability by comparing it to another's). Yet no study has examined the impact of social media use and comparison on disordered eating among middle-aged women. Participants (N = 347), ages 40-63, completed an online survey about their social media use, social comparison, and disordered eating (bulimic symptoms, dietary restraint, and broad eating pathology). Results indicated that 89 % (n = 310) of middle-aged women used social media in the past year. Most participants (n = 260; 75 %) used Facebook, and at least a quarter used Instagram or Pinterest. Approximately 65 % (n = 225) used social media at least daily. Controlling for age and body mass index, social media-specific social comparison was positively associated with bulimic symptoms, dietary restriction, and broad eating pathology (all ps < 0.001). Multiple regression models evaluating frequency of social media use and social media-specific social comparison together revealed that social comparison explained a significant amount of unique variance in bulimic symptoms, dietary restriction, and broad eating pathology (all ps < 0.001) above and beyond frequency of social media use. Instagram explained a significant proportion of variance of dietary restraint compared to other social media platforms (p = .001). Findings suggest a large percentage of middle-aged women frequently engage with some type of social media. Further, social media-specific social comparison, rather than frequency of social media use, may be driving disordered eating in this age group of women.
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Imagem Corporal , Dieta Redutora , Transtornos da Alimentação e da Ingestão de Alimentos , Mídias Sociais , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Índice de Massa Corporal , Bulimia/epidemiologia , Dieta Redutora/estatística & dados numéricos , Transtornos da Alimentação e da Ingestão de Alimentos/epidemiologia , Transtornos da Alimentação e da Ingestão de Alimentos/etiologia , Mães , Estimulação Luminosa , Mídias Sociais/estatística & dados numéricos , Valores Sociais , Inquéritos e Questionários , Saúde da Mulher/estatística & dados numéricosRESUMO
Objective. This study aimed to confirm the multidimensionality of benefit finding (BF), or silver linings within the cancer experience, assess the effects of Cognitive Behavioral Stress Management (CBSM) on those dimensions, and test the mediating role of perceived stress management skills targeted by CBSM.Methods. This secondary analysis used data from 240 women with stage 0-III breast cancer who completed measures of BF (Benefit Finding Scale) and perceived stress management skills (PSMS) at baseline, 6-months, and 12-months post-randomization into CBSM or a psycho-education condition. We tested a six-factor BF model using Confirmatory Factor Analysis and assessed CBSM-related changes in BF and PSMS using Hierarchical Linear Models. We included significantly affected BF dimensions in mediation models.Results. A six-factor model of BF had good fit [χ2(212) = 391.5, p < .001; CFI = 0.94; RMSEA = 0.06; SRMR = 0.04]. CBSM positively affected changes in personal growth (ß = 0.06, p = .01), social relations (ß = 0.05, p = .05), and worldview (ß = 0.05, p = .02) BF. Perceived relaxation skill increases significantly mediated changes in personal growth (ß = 0.03, p = .04) and social relations (ß = 0.03, p = .04).Conclusion. Some aspects of perceived stress management skills appear to account for specific BF dimensions and should be considered in future efforts to develop interventions to modulate BF.
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Purpose: Identifying clinically relevant comorbidities and their effect on health-related quality of life (HRQoL) outcomes among men with advanced prostate cancer (APC) can inform patient care and improve outcomes; however, this is poorly understood. The aim of this observational study was to examine the prevalence of comorbidities, and the relationship of comorbidity burden to HRQoL and other patient-reported outcomes (PROs) among men with APC. Methods: Participants were 192 men (average age 68.8) with APC (stage III or IV) who completed a psychosocial battery including measures of sociodemographic factors, HRQoL and other PROs, and the Charlson Comorbidity Index (CCI). Hierarchical multiple regression analysis was used to examine the relationships between CCI, HRQOL, and PROs. Results: The vast majority (82%) of participants had at least one comorbidity, with the most common being: hypertension (59%), connective tissue disease or arthritis (31%), diabetes (24%), and problems with kidneys, vision, or another organ (24%). After controlling for covariates, regressions showed that a higher CCI score was significantly associated with worse HRQoL ( p < 0.001), lower levels of positive affect ( p < 0.05), and higher levels of depression ( p < 0.05), fatigue ( p < 0.001), pain ( p < 0.01), stress ( p < 0.01), and cancer-specific distress ( p < 0.05). Conclusions: Comorbidities were common among men with APC, and a greater CCI score was associated with detriments in several domains of HRQoL and other PROs. Our findings show the need to address comorbidities in the presence of a cancer diagnosis and subsequent treatment.
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OBJECTIVE: Relationship status predicts numerous outcomes among medical populations. Few interventions evaluate the role of marital status on response to psychosocial treatment, and no such studies exist within advanced prostate cancer (APC). This study examined whether marital status modified the effect of a cognitive behavioral stress management (CBSM) intervention on perceived stress. METHODS: Men with APC (N = 190) were randomized to 10-week CBSM or a health promotion (HP) intervention (#NCT03149185). The Perceived Stress Scale assessed perceived stress at baseline and 12-month follow-up. Medical status and sociodemographics were captured at enrollment. RESULTS: Participants were mostly White (59.5%), non-Hispanic (97.4%), heterosexual (97.4%) men, 66.8% of whom were partnered. Neither condition nor marital status predicted perceived stress change at follow-up. However, a significant interaction was found between condition and marital status (p = 0.014; Cohen's f = 0.07), such that partnered men who received CBSM and unpartnered men who received HP reported greater reductions in perceived stress. CONCLUSION: This is the first study to assess the impact of marital status on psychosocial intervention effects among men with APC. Partnered men derived greater benefit from a cognitive-behavioral intervention and unpartnered men equally benefitted from a HP intervention. Further research is necessary to understand the mechanisms underlying these relationships.
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Neoplasias da Próstata , Estresse Psicológico , Masculino , Humanos , Estresse Psicológico/psicologia , Psicoterapia , Estado Civil , CogniçãoRESUMO
Sleep facilitates memory storage and even brief periods of sleep loss lead to impairments in memory, particularly memories that are hippocampus dependent. In previous studies, we have shown that the deficit in memory seen after sleep loss is accompanied by deficits in synaptic plasticity. Our previous work has also found that sleep deprivation (SD) is associated with reduced levels of cyclic adenosine monophosphate (cAMP) in the hippocampus and that the reduction of cAMP mediates the diminished memory observed in sleep-deprived animals. Based on these findings, we hypothesized that cAMP acts as a mediator for not only the cognitive deficits caused by sleep deprivation, but also the observed deficits in synaptic plasticity. In this study, we expressed the heterologous Drosophila melanogaster Gαs-protein-coupled octopamine receptor (DmOctß1R) in mouse hippocampal neurons. This receptor is selectively activated by the systemically injected ligand (octopamine), thus allowing us to increase cAMP levels in hippocampal neurons during a 5-h sleep deprivation period. Our results show that chemogenetic enhancement of cAMP during the period of sleep deprivation prevents deficits in a persistent form of long-term potentiation (LTP) that is induced at the Schaffer collateral synapses in the hippocampal CA1 region. We also found that elevating cAMP levels in either the first or second half of sleep deprivation successfully prevented LTP deficits. These findings reveal that cAMP-dependent signaling pathways are key mediators of sleep deprivation at the synaptic level. Targeting these pathways could be useful in designing strategies to prevent the impact of sleep loss.
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Drosophila melanogaster , Privação do Sono , Camundongos , Animais , Privação do Sono/metabolismo , Drosophila melanogaster/metabolismo , Hipocampo/metabolismo , Plasticidade Neuronal/fisiologia , AMP Cíclico/metabolismo , Potenciação de Longa Duração/fisiologiaRESUMO
PURPOSE: Men with advanced prostate cancer (APC) experience high levels of pain, which contribute to poor psychosocial and functional outcomes. Cancer-related distress explains the relationship between pain severity and interference, yet specificity of distress characteristics (e.g., hyperarousal, intrusive, or avoidant symptoms) in explaining associations between pain experiences and well-being has not been explored within APC. This study examined men with APC entering a clinical trial and tested associations of baseline pain, cancer-related distress, and physical and functional well-being. METHODS: One hundred ninety men with APC enrolled in a randomized-controlled trial and were assessed prior to randomization. The McGill Pain Questionnaire assessed pain severity, and the Functional Assessment of Cancer Therapy-General captures physical and functional well-being. The Impact of Events Scale-Revised measured cancer-specific distress symptoms, including hyperarousal, avoidance, and intrusion symptoms. Controlling for age, cancer stage at diagnosis, income, education, and race/ethnicity, mediation models (SPSS PROCESS, model 4) tested whether cancer-specific distress accounted for the associations between pain severity and physical and functional well-being. RESULTS: Men were on average 68 years of age, White non-Hispanic, with stage IV cancer. Pain severity was related to poorer physical (p < .001) and functional well-being (p < .001). Associations between pain severity and physical and functional well-being were partially mediated by greater intrusive and hyperarousal symptoms but not avoidant symptoms. CONCLUSION: For men with APC, intrusive and hyperarousal symptoms may partially explain the relationship between pain severity and decrements in physical and functional well-being. APC pain management should attend to such distress symptoms, which may contribute to interference if left unaddressed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03149185.
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Dor do Câncer , Neoplasias da Próstata , Masculino , Humanos , Dor do Câncer/etiologia , Neoplasias da Próstata/psicologia , Estadiamento de Neoplasias , Medição da DorRESUMO
OBJECTIVE: Targets of intervention in cognitive behavioral stress management (CBSM), such as benefit finding (BF) and perceived stress management skills (PSMS), may counteract stress-related changes that impact the immune system. This study tested whether BF, PSMS, and optimism influence the effects of CBSM on immune status in men with prostate cancer. METHODS: Men with prostate cancer were randomized to receive CBSM or a psychoeducation (PE) control comparison (NCT05486754). Life Orientation Test-Revised assessed baseline optimism. The Benefit Finding Scale and Measure of Current Status measured BF and PSMS after CBSM. T-cells and T-helper cells captured immune status change at baseline and 6-months post-CBSM. MPlus and SPSS (PROCESS) tested condition effects and moderated mediation, controlling for covariates. RESULTS: 256 primarily middle-aged, White Non-Hispanic or Hispanic men enrolled. PSMS mediated CBSM effects on T-cell and T-helper cell percentage, such that T-cell and T-helper cell percentages were reduced in men in CBSM versus PE via PSMS. Optimism moderated this mediation with the mediating effect of PSMS only observed among men with average optimism versus those with low or high optimism. CONCLUSION: Baseline psychological characteristics, as well as limited specificity of immune measurement, could explain the conditional effects in this sample. TRIAL REGISTRATION: NCT05486754.
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Terapia Cognitivo-Comportamental , Neoplasias da Próstata , Pessoa de Meia-Idade , Masculino , Humanos , Estresse Psicológico/terapia , Estresse Psicológico/psicologia , Qualidade de Vida/psicologia , Neoplasias da Próstata/terapia , Neoplasias da Próstata/psicologia , CogniçãoRESUMO
OBJECTIVES: Most patients report pain while taking adjuvant endocrine therapy (AET) for the treatment of breast cancer. While studies have examined patients' experiences with side effects, none solely capture patients' experiences with AET-related pain, a troubling symptom that reduces quality of life and impairs treatment adherence. This study explored themes of AET-related pain to inform future intervention development. METHODS: Between November 2017 and November 2018, female patients (n = 30) with early-stage breast cancer enrolled between 3 and 36 months post-initiation of AET. Purposeful sampling was stratified by adherence level, age, distress level and time taking AET. Study staff conducted, transcribed and coded semi-structured interviews via inductive thematic coding to identify pain-related themes and achieved high inter-coded reliability (Kappa = 0.96). RESULTS: Several pain-related themes were observed. Attitudes around pain are generally negative, and management needs are largely unmet. Patients reported preferences for non-pharmacological management strategies and cited AET pain as a reason for medication breaks but not discontinuation. Patients within 19 months of starting AET and low adherers reported more intense and disruptive pain. CONCLUSIONS: Patients' experiences varied by patient attributes and revealed modifiable factors that may be targeted through behavioural interventions. AET-related pain is a complex side effect for which psychosocial support may be beneficial.
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Neoplasias da Mama , Feminino , Humanos , Antineoplásicos Hormonais/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/psicologia , Quimioterapia Adjuvante/efeitos adversos , Adesão à Medicação , Dor/induzido quimicamente , Dor/tratamento farmacológico , Qualidade de Vida , Reprodutibilidade dos TestesRESUMO
BACKGROUND: Patients taking adjuvant endocrine therapy (AET) after breast cancer face adherence challenges and symptom-related distress. We conducted a randomized trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth intervention (Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy [STRIDE]) for patients taking AET. METHODS: From October 2019 to June 2021, 100 patients reporting difficulty with AET were randomly assigned to either STRIDE or a medication monitoring (MedMon) control group. STRIDE included six weekly small-group videoconferencing sessions and two individual calls. We defined feasibility as having >50% of eligible patients enroll, >70% complete the 12-week assessment, and > 70% of STRIDE patients complete ≥4/6 sessions. We monitored adherence with the Medication Event Monitoring System Caps (MEMS Caps). At baseline and 12- and 24-weeks after baseline, patients self-reported adherence (Medication Adherence Report Scale), AET satisfaction (Cancer Therapy Satisfaction Questionnaire), symptom distress (Breast Cancer Prevention Trial-Symptom Checklist), self-management of symptoms (Self-efficacy for Symptom Management-AET), coping (Measure of Current Status), quality of life (QOL; Functional Assessment of Cancer Therapy-Breast), and mood (Hospital Anxiety and Depression Scale). We used linear mixed effects models to assess the effect of STRIDE on longitudinal outcomes. RESULTS: We enrolled 70.9% (100/141) of eligible patients; 92% completed the 12-week assessment, and 86% completed ≥4/6 STRIDE sessions. Compared with MedMon, STRIDE patients reported less symptom distress (B[difference] = -1.91; 95% CI, -3.29 to -0.52; p = .007) and better self-management of AET symptoms, coping, QOL, and mood. We did not observe significant differences in AET satisfaction or adherence. CONCLUSIONS: STRIDE is feasible and acceptable, showing promise for improving outcomes in patients taking AET after breast cancer. LAY SUMMARY: Patients taking adjuvant endocrine therapy (AET) after breast cancer may face challenges while following their treatment regimen. In this randomized controlled trial of 100 patients taking AET, a brief, small-group virtual intervention (STRIDE) was well-received by patients and led to improvements in how upset patients were due to symptoms, how confident they were in managing symptoms, and how well they could cope with stress. Thus, STRIDE is a promising intervention and should be tested in future multi-site trials.
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Neoplasias da Mama , Telemedicina , Feminino , Humanos , Adjuvantes Imunológicos , Neoplasias da Mama/tratamento farmacológico , Quimioterapia Adjuvante , Terapia Combinada , Adesão à Medicação , Qualidade de VidaRESUMO
BACKGROUND: The emotional health of adolescent and young adult (AYA) cancer survivors is compromised both during and after cancer treatment. Targeted programs designed to support AYAs' ability to cope with stress in the years following treatment completion are lacking. Mind-body programs may ameliorate the negative psychological and emotional effects of stress and assist AYAs with managing the psychosocial challenges of early survivorship. OBJECTIVE: Our randomized waitlist-control trial aims to assess the feasibility, acceptability, and preliminary efficacy of a virtual group program (Bounce Back) to promote stress management and resiliency among posttreatment AYAs. METHODS: Bounce Back is a stress management and resiliency program delivered via videoconference by a trained mental health clinician. Sessions were adapted from an evidence-based mind-body program (Stress Management and Resiliency Training - Relaxation Response Resiliency Program [SMART-3RP]) grounded in relaxation response elicitation, mindfulness, cognitive behavioral therapy, and positive psychology. Seventy-two AYAs (diagnosed with cancer between ages 14 years and 29 years and had completed cancer treatment within the last 5 years) were randomly assigned to the Bounce Back program or waitlist-control group and completed assessments at baseline, 3 months postbaseline, and 6 months postbaseline. The primary aim of the study is to determine the feasibility and acceptability of the Bounce Back program. Descriptive statistics, including means, frequencies, and ranges supplemented by qualitative exit interview feedback will be used to characterize the sample and to summarize feasibility and acceptability. The exploratory aims are to evaluate the preliminary effects of the program on stress coping and psychosocial outcome measures (ie, anxiety, depression) collected across the 3 time points. RESULTS: This study was funded by the National Cancer Institute in July 2017. Study procedures were approved by the Dana-Farber Harvard Cancer Center Institutional Review Board in October 2018 (Protocol 18-428). The randomized trial was conducted from July 2019 to March 2021. Quantitative data collection is complete, and qualitative exit interview data collection is ongoing. Results are expected to be published in peer-reviewed journals and presented at local, national, or international meetings in the coming years. CONCLUSIONS: Few evidence-based programs exist that tackle the key transitional issues faced by AYA cancer survivors. Future analyses will help us determine the feasibility and acceptability of the Bounce Back program and its impact on AYA stress coping and psychological well-being. TRIAL REGISTRATION: ClinicalTrials.gov NCT03768336; https://clinicaltrials.gov/ct2/show/NCT03768336. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34033.
RESUMO
PURPOSE: Despite life-saving potential, many women struggle to adhere to adjuvant endocrine therapy (AET) for their breast cancer (BCa). Prior research has demonstrated that emotional distress is a barrier to AET adherence. We followed women from a trial to test the long-term effects of two 5-week post-surgical group-based stress management interventions, cognitive behavioral therapy (CBT), and relaxation training versus an attention-matched health education control, on AET adherence. METHODS: We conducted a long-term follow-up (median = 8 years) of women randomized to CBT, relaxation training, or health education after surgery for stage 0-3 BCa. We measured adherence with the Endocrine Therapy Medication Usage Questionnaire (ETMUQ). First, we established factors on the ETMUQ via confirmatory factor analysis. We then used Bayesian structural equation modeling to regress these factors on study arm, controlling for age and treatments received. RESULTS: Of those who completed long-term follow-up (n = 59, 44.7%), over half (n = 33; 55.9%) reported problems with adherence generally. Women receiving relaxation training (n = 15) had better adherence than those receiving health education (n = 24) on the Forgetfulness/Inconsistency [B(SE) = 0.25(0.14), p = 0.049] and Intentional Nonadherence [B(SE) = 0.31(0.14), p = 0.018] factors of the ETMUQ. Similar results were observed for those receiving relaxation training compared to CBT (n = 20): Forgetfulness/Inconsistency [B(SE) = - 0.47(0.25), p = 0.031]; Intentional Nonadherence [B(SE) = - 0.31(0.15), p = 0.027]. CONCLUSION: Women receiving relaxation training were less likely to (1) forget to take their AET and (2) intentionally miss doses of AET in the long term compared to women receiving health education or CBT. This is evidence for the need of randomized trials that aim to improve adherence by incorporating theoretically based behavioral change techniques. TRIAL REGISTRATION AND DATES: Trial 2R01-CA-064710 was registered March 26, 2006.