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BACKGROUND: Partner support is associated with better weight loss outcomes in observational studies, but randomized trials show mixed results for including partners. Unclear is whether teaching communication skills to couples will improve weight loss in a person attempting weight loss (index participant). PURPOSE: To compare the efficacy of a partner-assisted intervention versus participant-only weight management program on 24-month weight loss. METHODS: This community-based study took place in Madison, WI. Index participants were eligible if they met obesity guideline criteria to receive weight loss counseling, were aged 18-74 years, lived with a partner, and had no medical contraindications to weight loss; partners were aged 18-74 years and not underweight. Couples were randomized 1:1 to a partner-assisted or participant-only intervention. Index participants in both arms received an evidence-based weight management program. In the partner-assisted arm, partners attended half of the intervention sessions, and couples were trained in communication skills. The primary outcome was index participant weight at 24 months, assessed by masked personnel; secondary outcomes were 24-month self-reported caloric intake and average daily steps assessed by an activity tracker. General linear mixed models were used to compare group differences in these outcomes following intent-to-treat principles. RESULTS: Among couples assigned to partner-assisted (n = 115) or participant-only intervention (n = 116), most index participants identified as female (67%) and non-Hispanic White (87%). Average baseline age was 47.27 years (SD 11.51 years) and weight was 106.55 kg (SD 19.41 kg). The estimated mean 24-month weight loss was similar in the partner-assisted (2.66 kg) and participant-only arms (2.89 kg) (estimated mean difference, 0.23 kg [95% CI, -1.58, 2.04 kg], p=0.80). There were no differences in 24-month average daily caloric intake (estimated mean difference 50 cal [95% CI: -233, 132 cal], p=0.59) or steps (estimated mean difference 806 steps [95% CI: -1675, 64 steps], p=0.07). The percentage of participants reporting an adverse event with at least possible attribution to the intervention did not differ by arm (partner-assisted: 9%, participant-only, 3%, p = 0.11). CONCLUSIONS: Partner-assisted and individual weight management interventions led to similar outcomes in index participants. TRIAL REGISTRATION: Clinicaltrials.gov NCT03801174, January 11, 2019.
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Redução de Peso , Programas de Redução de Peso , Humanos , Pessoa de Meia-Idade , Masculino , Feminino , Adulto , Idoso , Programas de Redução de Peso/métodos , Cônjuges/psicologia , Adolescente , Obesidade/terapia , Adulto Jovem , Wisconsin , Resultado do TratamentoRESUMO
BACKGROUND: Psychological distress symptoms are present and persistent among many patients who survive a critical illness like COVID-19. RESEARCH QUESTION: Could a self-directed mobile app-delivered mindfulness intervention be feasibly and rapidly implemented within a clinical trials network to reduce distress symptoms? STUDY DESIGN AND METHODS: A randomized clinical trial was conducted between January 2021 and May 2022 at 29 US sites and included survivors of hospitalization due to COVID-19-related illness with elevated symptoms of depression at discharge. Participants were randomized to intervention or usual care control. The intervention consisted of four themed weeks of daily audio, video, and text content. All study procedures were virtual. The primary outcome was depression symptoms assessed with the Patient Health Questionnaire 9 at 3 months. Secondary outcomes included anxiety (Generalized Anxiety Disorder 7-item scale), quality of life (EQ-5D), and adherence. We used general linear models to estimate treatment arm differences in outcomes over time. RESULTS: Among 56 randomized participants (mean age ± SD, 51.0 ± 13.2 years; 38 female [67.9%]; 14 Black participants [25%]), 45 (intervention: n = 23 [79%]; control: n = 22 [81%]) were retained at 6 months. There was no difference in mean improvement between intervention and control participants at 3 months in Patient Health Questionnaire 9 (-0.5 vs 0.1), Generalized Anxiety Disorder 7-item scale (-0.3 vs 0.1), or EQ-5D (-0.03 vs 0.02) scores, respectively; 6-month results were similar. Only 15 participants (51.7%) initiated the intervention, whereas the mean number ± SD of the 56 prescribed intervention activities completed was 12.0 ± 15.2. Regulatory approvals delayed trial initiation by nearly a year. INTERPRETATION: Among survivors of COVID-19 hospitalization with elevated psychological distress symptoms, a self-directed mobile app-based mindfulness intervention had poor adherence. Future psychological distress interventions mobilized at broad scale should focus efforts on patient engagement and regulatory simplification to enhance success. TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT04581200; URL: www.clinicaltrials.gov.
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Given the bidirectional association between psychopathology and relationship distress, an in-depth understanding of couples' interaction processes that contribute to psychopathology is needed. This study examined the interpersonal dynamics of vocally-encoded emotional arousal (fundamental frequency, f0) during couple conversations and their associations with depressive symptoms, anxiety symptoms, and relationship distress. Data from eight samples were pooled (N = 404 couples) to examine (a) overall trajectories of f0 across the interaction and (b) moment-by-moment intraindividual changes in and interpersonal reactivity to partners' f0. Multilevel growth models and repeated-measures actor-partner interdependence models demonstrated that individuals with more severe depression showed more synchronizing reactivity to their partners' f0 on a moment-by-moment basis, and their overall baseline level of f0 was lower. More severe relationship distress was associated with more steeply increasing trajectories of f0 and with greater synchronizing reactivity to partners' f0. Relative differences in depressive symptoms between the two members of a couple were associated with interpersonal dynamics of f0 as well. There were no associations with anxiety symptoms. Thus, depressive symptoms were associated with characteristic interpersonal dynamics of vocally-encoded emotional arousal; yet, most consistent associations emerged for relationship distress, which future studies on individual psychopathology should take into account.
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Ansiedade , Depressão , Relações Interpessoais , Humanos , Feminino , Masculino , Depressão/psicologia , Ansiedade/psicologia , Adulto , Angústia Psicológica , Adulto Jovem , Pessoa de Meia-Idade , Nível de Alerta , EmoçõesRESUMO
This study develops a technology-based dyadic intervention to enhance symptom management and health equity in underserved patients with colorectal cancer and their caregivers. Leveraging generative artificial intelligence, the intervention provides tailored educational contents to meet individual unmet needs.
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Cuidadores , Neoplasias Colorretais , Humanos , Neoplasias Colorretais/terapia , Cuidadores/educação , Inteligência Artificial , Educação de Pacientes como Assunto/métodos , Área Carente de Assistência MédicaRESUMO
Objective: Existing behavioral weight management interventions produce clinically meaningful weight loss. The onset of the COVID-19 pandemic led to the quick transition of such interventions from in-person to virtual platforms. This provided a unique opportunity to compare engagement and outcomes for an in-person versus virtually delivered weight management intervention. Methods: A non-randomized comparison of engagement and weight outcomes was performed between two cohorts who participated in a weight management intervention in person (N = 97) versus three who participated virtually via videoconference (N = 134). Various metrics of engagement were examined, including group class and individual phone call attendance and duration, and retention for weight assessments. Behavioral targets of daily caloric intake and step-counts and the clinical weight outcome were explored. Results: Cohorts (mean [standard deviation] age 47.3 (11.5), 67.1% women: 86.8% White) that participated virtually attended more group sessions (p < 0.001) and had maintenance telephone calls that were of a longer duration (p < 0.001). No other engagement or weight outcomes significantly differed by delivery modality. Conclusions: Virtual weight management programs are promising and may generate similar outcomes to those delivered in-person. Future research should seek to understand how best to promote and sustain engagement in virtual interventions.
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Importance: Although psychological distress is common among survivors of critical illness, there are few tailored therapies. Objective: To determine the optimal method for delivering a mindfulness intervention via a mobile app for critical illness survivors. Design, Setting, and Participants: This randomized clinical trial used a 2 × 2 × 2 factorial design and was conducted at 3 sites among survivors of critical illness with elevated postdischarge symptoms of depression. The study was conducted between August 2019 and July 2023. Interventions: Participants were randomized to 1 of 8 different groups as determined by 3 two-level intervention component combinations: intervention introduction method (mobile app vs therapist call), mindfulness meditation dose (once daily vs twice daily), and management of increasing symptoms (mobile app vs therapist call). Main Outcomes and Measures: The primary outcome was the 9-item Patient Health Questionnaire (PHQ-9) depression scale score (range, 0-27) at 1 month. Secondary outcomes included anxiety (7-item Generalized Anxiety Disorder) and posttraumatic stress disorder (Posttraumatic Stress Scale) symptoms at 1 and 3 months, adherence, and feasibility. General linear models were used to compare main effects and interactions of the components among intervention groups. A formal decisional framework was used to determine an optimized intervention version. Results: A total of 247 participants (mean [SD] age, 50.2 [15.4] years; 104 [42.1%] women) were randomized. Twice-daily meditation compared with once-daily meditation was associated with a 1.2 (95% CI, 0.04-2.4)-unit lower mean estimated PHQ-9 score at 1 month and a 1.5 (95% CI, 0.1-2.8)-unit lower estimated mean score at 3 months. The other 2 intervention components had no main effects on the PHQ-9. Across-group adherence was high (217 participants [87.9%] using the intervention at trial conclusion) and retention was strong (191 [77.3%] and 182 [73.7%] at 1 and 3 months, respectively). Conclusions and Relevance: A mindfulness intervention for survivors of critical illness that included an app-based introduction, twice-daily guided meditation, and app-based management of increasing depression symptoms was optimal considering effects on psychological distress symptoms, adherence, and feasibility. Trial Registration: ClinicalTrials.gov Identifier: NCT04038567.
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Estado Terminal , Unidades de Terapia Intensiva , Atenção Plena , Angústia Psicológica , Sobreviventes , Humanos , Atenção Plena/métodos , Feminino , Masculino , Pessoa de Meia-Idade , Sobreviventes/psicologia , Estado Terminal/psicologia , Estado Terminal/terapia , Aplicativos Móveis , Adulto , Meditação/métodos , Idoso , Transtornos de Estresse Pós-Traumáticos/terapia , Transtornos de Estresse Pós-Traumáticos/psicologiaRESUMO
Psychological distress while coping with cancer is a highly prevalent and yet underrecognized and burdensome adverse effect of cancer diagnosis and treatment. Left unaddressed, psychological distress can further exacerbate poor mental health, negatively influence health management behaviors, and lead to a worsening quality of life. This multimethod study primarily focused on understanding veterans' psychological distress and personal experiences living with lung cancer (an underrepresented patient population). In a sample of 60 veterans diagnosed with either nonsmall cell lung cancer (NSCLC) or small cell lung cancer (SCLC), we found that distress is common across clinical psychology measures of depression (37% [using the Patient Health Questionnaire, PHQ-9 measure]), anxiety (35% [using the Generalized Anxiety Disorder, GAD-7 measure]), and cancer-related posttraumatic stress (13% [using the Posttraumatic Stress Symptom Checklist measure]). A total of 23% of the sample endorsed distress scores on two or more mental health screeners. Using a broader cancer-specific distress measure (National Comprehensive Cancer Network), 67% of our sample scored above the clinical cutoff (i.e., ≥ 3), and in the follow-up symptom checklist of the National Comprehensive Cancer Network measure, a majority endorsed feeling sadness (75%), worry (73%), and depression (60%). Qualitative analysis with a subset of 25 veterans highlighted that psychological distress is common, variable in nature, and quite bothersome. Future research should (a) identify veterans at risk for distress while living with lung cancer and (b) test supportive mental health interventions to target psychological distress among this vulnerable veteran population. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
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Reductions in physical activity (PA) are common among patients following hematopoietic cell transplantation, and a risk factor for poor physical functioning. PA among spouses/cohabiting partners, who frequently serve as the patient's primary caregiver, may also be reduced due to caregiving demands and limited bandwidth for self-care. In addition, the patient-caregiver relationship can be compromised, and communication patterns disrupted. All PA interventions in the hematopoietic cell transplantation setting have focused entirely on patients, ignoring an opportunity to synergistically engage and benefit the caregiver as well. We sought to test feasibility and acceptability of a couple-based intervention entitled Family-Focused Facilitated Fitness (FFFF), designed to improve PA as assessed by daily step counts among both patients undergoing hematopoietic cell transplantation and their caregivers. Guided by interdependence and communal coping perspectives, FFFF is an 8-week, remotely-delivered intervention that provides training in communication skills and joint problem-solving to help patients and caregivers support one another in PA. Participants are also given a Fitbit to track their steps and weekly individualized step prescription based on the 75th percentile ranked value of their last 7 recorded daily step counts. A priori benchmarks for feasibility and acceptability in this single-arm pilot were as follows: 50% of eligible couples would agree to participate, 70% of couples would attend all 8 sessions, 80% of participants would provide valid Fitbit wear data 4/7 days/ week, and among sessions reviewed for treatment fidelity, 85% of treatment protocol elements would be covered. Couples were recruited prior to transplant. Among 26 couples approached and deemed eligible, 17 enrolled (65% agreement) and completed baseline assessment. Three couples later withdrew after transplantation but prior to receiving the intervention, resulting in 14 couples commencing the intervention, on average 21 days post-transplant. Four couples subsequently discontinued due to medical complications (n = 3) or caregiver schedule (n = 1). Among the 10 couples who completed the intervention, the percentage of participants meeting our benchmark of valid Fitbit wear at least 4 days per week was 85% in week 1, 90% in weeks 2 to 7, and 80% in week 8. Treatment fidelity was 95% on average across 24 sessions reviewed (3 cases). Treatment satisfaction scores were uniformly high across multiple dimensions, with all means above 4 on the 1 to 5 scale. Daily step counts among those attending all 8 intervention sessions increased from 2249 ± 302 steps/day in week 1 to 4975 ± 1377 steps/day in week 8 among patients, and from 8676 ± 3760 steps/day in week 1 to 9838 ± 3723 steps/day in week 8 among caregivers. Qualitative feedback indicated perceived mental and physical health benefits of the program. Participants also offered suggestions for adaptations to accommodate medical setbacks and constraints. All a priori feasibility benchmarks were met or exceeded. Results offer promise for utility of the program to engage and leverage patient-caregiver dyads to increase PA following transplant. An investigation using a randomized controlled design will be necessary to adequately examine change over time relative to control and its possible impact on clinical and patient-reported outcomes.
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Transplante de Células-Tronco Hematopoéticas , Humanos , Transplantados , Estudos de Viabilidade , Exercício FísicoRESUMO
Cancer poses a set of physical and emotional challenges to the patient, spouse, and their relationship. One challenge for couples is discussing cancer-related concerns in a manner that facilitates intimacy. Current couple-based interventions have been shown to have mixed efficacy, and little is known about how they bring about improvements. This study aims to expand our understanding of dyadic communication and intimacy to adapt and/or develop more effective interventions for couples coping with cancer. To accomplish this goal, the present study examined affective and behavioral processes associated with intimacy using the valence-affective-connection (VAC) framework and observational coding methods. Participants were 134 couples in which a patient was diagnosed with breast, colorectal, or lung cancer. Couples completed a battery of questionnaires, including a self-report measure of intimacy. Couples also completed a 15-min videotaped interaction about a cancer topic of their choosing, which was observationally coded for communication behavior and affective expression. Couples coping with cancer who reported higher versus lower intimacy engaged in qualitatively different levels, types, and patterns of communication behavior and affective expression. Specifically, couples who reported lower relationship intimacy used negative approach behavior and hard negative affect more frequently and for longer periods of time and were more likely to use avoidance-based communication. Higher intimacy couples were less likely to sustain the use of negative behavior and affect and displayed more reciprocity of positive joining affect. The study highlights important considerations for couple-based interventions and research in the context of cancer. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
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Adaptação Psicológica , Neoplasias , Humanos , Relações Interpessoais , Comportamento Sexual/psicologia , ComunicaçãoRESUMO
OBJECTIVES: Limited evidence investigates how knowledge, misconceptions, and beliefs about palliative care vary across patients with cancerous versus non-cancerous chronic disease. We examined the knowledge of and misconceptions about palliative care among these groups. METHODS: We used weighted data from the National Cancer Institute Health Information National Trends Survey 5 (Cycle 2) for nationally representative estimates and logistic regression to adjust for respondent characteristics. We identified respondents who reported having (1) cancer ([n = 585]; breast, lung, and colorectal), (2) chronic conditions ([n = 543]; heart failure, lung disease, or chronic obstructive pulmonary disorder), or (3) neither cancer nor other chronic conditions (n = 2,376). RESULTS: Compared to cancer respondents, chronic condition respondents were more likely to report being Black or Hispanic, report a disability, and have lower socioeconomic status. In the sample, 65.6% of cancer respondents and 72.8% chronic conditions respondents reported they had never heard of palliative care. Chronic condition respondents were significantly (p < 0.05) less likely to report high palliative care knowledge than cancer respondents (9.1% vs. 16.6%, respectively). In adjusted analyses, cancer respondents had greater odds of high palliative care knowledge (odd ratio [OR] = 1.70; 95% confidence interval [CI] = 1.01, 2.86) compared to respondents with neither cancer nor chronic disease; chronic condition respondents did not have increased odds (OR = 0.96; CI = 0.59, 1.54). SIGNIFICANCE OF RESULTS: Disparities in palliative care knowledge exist among people with non-cancerous chronic disease compared to cancer. Supportive educational efforts to boost knowledge about palliative care remains urgent and is critical for promoting equity, particularly for underserved people with chronic illnesses.
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BACKGROUND: Patients with colorectal cancer (CRC) receiving chemotherapy often experience psychoneurological symptoms (PNS; ie, fatigue, depression, anxiety, sleep disturbance, pain, and cognitive dysfunction) that negatively impact both patients' and their caregivers' health outcomes. Limited information is available on PNS management for CRC patient and caregiver dyads. OBJECTIVE: The purposes of this study are to (1) develop a web-based dyadic intervention for patients with CRC receiving chemotherapy and their caregivers (CRCweb) and (2) evaluate the feasibility, acceptability, and preliminary effects of CRCweb among patient-caregiver dyads in a cancer clinic. METHODS: A mixed methods approach will be used. Semistructured interviews among 8 dyads will be conducted to develop CRCweb. A single-group pre- and posttest clinical trial will be used to examine the feasibility, acceptability, and preliminary effects of the intervention (CRCweb) among 20 dyads. Study assessments will be conducted before (T1) and after intervention (T2). Content analysis will be performed for semistructured interviews. Descriptive statistics will be calculated separately for patients and caregivers, and pre-post paired t tests will be used to evaluate treatment effects. RESULTS: This study was funded in November 2022. As of April 2023, we have obtained institutional review board approval and completed clinical trial registration and are currently recruiting patient-caregiver dyads in a cancer clinic. The study is expected to be completed in October 2024. CONCLUSIONS: Developing a web-based dyadic intervention holds great promise to reduce the PNS burden in patients with CRC receiving chemotherapy and their caregivers. The findings from this study will advance intervention development and implementation of symptom management and palliative care for patients with cancer and their caregivers. TRIAL REGISTRATION: ClinicalTrials.gov NCT05663203; https://clinicaltrials.gov/ct2/show/NCT05663203. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48499.
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Rationale: The coronavirus disease (COVID-19) pandemic exacerbated psychological distress and burnout in frontline healthcare workers. Interventions addressing psychological distress and burnout among these workers are lacking. Objectives: To determine the feasibility and explore the impact of mobile mindfulness to treat psychological distress and burnout among nurses in frontline COVID-19 units. Methods: We conducted a pilot randomized trial of 102 nurses working in COVID-19 units at a single hospital between May 2021 and January 2022. Participants were randomized to mobile mindfulness (intervention) or waiting list (control). The primary outcome was feasibility, assessed by comparing rates of randomization, retention, and intervention completion to predefined targets. Secondary outcomes were changes in psychological distress (Patient Health Questionnaire-9, General Anxiety Disorder-7, Perceived Stress Scale-4) and burnout symptoms (Maslach Burnout Inventory) after 1 month. Results: We randomized 102 of 113 consented individuals (90%, target 80%), and 88 completed follow-up (86%, target 80%). Among 69 intervention participants, 19 completed ⩾1 mindfulness session per week (28%, target 60%), and 13 completed ⩾75% of mindfulness sessions (19%, target 50%). Intervention participants had greater decreases in Patient Health Questionnaire-9 scores than control subjects (difference in differences, -2.21; 95% confidence interval, -3.99, -0.42; P = 0.016), but the Maslach Burnout Inventory depersonalization scores decreased more in the control arm than in the intervention arm (difference in differences, 1.60; 95% confidence interval, 0.18, 3.02; P = 0.027). There were no other changes in emotional distress or burnout symptoms. Conclusions: This trial of mobile mindfulness in frontline nurses met feasibility targets for randomization and retention, but participants had modest intervention use. Intervention participants had a reduction in depression symptoms, but not in burnout. Clinical trial registered with www.clinicaltrials.gov (NCT04816708).
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Esgotamento Profissional , COVID-19 , Atenção Plena , Angústia Psicológica , Humanos , Projetos Piloto , Esgotamento Profissional/psicologia , Esgotamento PsicológicoRESUMO
BACKGROUND: The experience of cancer can create considerable emotional distress for patients and their committed partners. How couples communicate about cancer-related concerns can have important implications for adjustment. However, past research has primarily utilized cross-sectional designs and retrospective self-reports of couple communication. While informative, little is known about how patients and partners express emotion during conversations about cancer, and how these emotional patterns predict individual and relational adjustment. PURPOSE: The current investigation examined how patterns of emotional arousal within couples' communication about cancer was associated with concurrent and prospective individual psychological and relational adjustment. METHODS: At baseline, 133 patients with stage II- breast, lung, or colorectal cancer and their partners completed a conversation about a cancer-related concern. Vocally expressed emotional arousal (f0) was extracted from recorded conversations. Couples completed self-report measures of individual psychological and relational adjustment at baseline and at 4, 8, and 12 months later. RESULTS: Couples who started the conversation higher in f0 (i.e., greater emotional arousal) reported better individual and relational adjustment at baseline. If the non-cancer partner had lower f0 relative to patients, this predicted worse individual adjustment across follow-up. Additionally, couples who maintained their level of f0 rather than decreasing later in the conversation reported improvements in individual adjustment across follow-up. CONCLUSIONS: Elevated emotional arousal within a cancer-related conversation may be adaptive for adjustment, as it may reflect greater emotional engagement and processing of an important topic. These results may suggest ways for therapists to guide emotional engagement to enhance resilience in couples experiencing cancer.
Cancer is a stressful experience for patients and their partners. We know that how couples communicate about cancer is important, but we do not know much about how couples express emotion during cancer conversations and how those emotional expressions affect well-being. Our study looked at how couples' emotional arousal within cancer conversations relate to individual and relationship well-being. At the beginning of the study, cancer patients and their partners had a conversation about cancer. Within these conversations, we tracked the emotional arousal expressed in their voices. Couples also completed surveys about their well-being at the beginning of the study and later in time (4, 8, and 12 months later). We found that couples who started the conversation with higher emotional arousal had better initial well-being. Couples who remained higher in arousal later in the conversation improved in their individual well-being over time. We also found that if the non-cancer partner was low in arousal compared with patients, this predicted worse well-being over time. More research is needed, but these findings suggest that being emotionally aroused during conversations about important topics like cancer might be helpful for well-being, potentially because couples are discussing concerns and not backing off when it feels challenging.
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Nível de Alerta , Comunicação , Ajustamento Emocional , Emoções Manifestas , Características da Família , Relações Familiares , Neoplasias , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Relações Familiares/psicologia , Seguimentos , Neoplasias/psicologia , Resiliência Psicológica , Gravação de Som , Voz , Apoio Familiar/psicologiaRESUMO
OBJECTIVE: For patients with advanced cancer, pain is a common and debilitating symptom that can negatively impact physical, emotional, and spiritual well-being. This trial examined the feasibility and initial effects of Meaning-Centered Pain Coping Skills Training (MCPC), a cognitive-behavioral pain management intervention with an emphasis on enhancing meaning (i.e., a personal sense of purpose, worth, and significance) and peace. METHODS: We enrolled 60 adults with stage IV solid tumor cancers and moderate-severe pain between February 2021 and February 2022. Participants were randomized 1:1 to MCPC + usual care or usual care alone. Meaning-Centered Pain Coping Skills Training consisted of four weekly 60-min individual sessions via videoconference or telephone, delivered by a trained therapist using a manualized protocol. Participants completed validated measures of pain severity, pain interference, pain self-efficacy, spiritual well-being (i.e., meaning, peace, and faith), and psychological distress at baseline and 5-week and 10-week follow-ups. RESULTS: All feasibility metrics exceeded prespecified benchmarks. Fifty-eight percent of screened patients were eligible, and 69% of eligible patients consented. Of those assigned to MCPC, 93% completed all sessions and 100% of those who completed follow-ups reported using coping skills weekly. Retention was strong at 5-week (85%) and 10-week (78%) follow-ups. Meaning-Centered Pain Coping Skills Training participants reported better scores than control participants across outcome measures, including moderate-to-large sized differences at 10-week follow-up in pain severity (Cohen's d = -0.75 [95% confidence interval: -1.36, -0.14]), pain interference (d = -0.82 [-1.45, -0.20]), and pain self-efficacy (d = 0.74 [0.13, 1.35]). CONCLUSIONS: MCPC is a highly feasible, engaging, and promising approach for improving pain management in advanced cancer. Future efficacy testing is warranted. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04431830, registered 16 June 2020.
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Segunda Neoplasia Primária , Neoplasias , Adulto , Humanos , Projetos Piloto , Neoplasias/terapia , Neoplasias/psicologia , Dor , Adaptação Psicológica , EmoçõesRESUMO
Cancer poses a threat to well-being that may activate the attachment system and influence interpersonal dynamics, such as communication. Research indicates that avoidant and anxious attachment, as well as communication, are independently associated with poorer psychosocial well-being, yet studies examining links between attachment, communication, and long-term physical well-being are lacking. We examined (a) associations between patient and partner attachment (measured with the adult attachment scale [AAS-Revised]) and observed communication (across affect [the Relational Affective Topography System (RATS) coding system] and behavior [the Asymmetric Behavior Coding System (ABCS) coding system]) and (b) the extent to which attachment and communication independently predicted long-term physical well-being (measured by the Functional Assessment of Cancer Therapy-General Population [FACT-GP]). Participants were 134 couples [mean age 53.9 (SD = 13.4), 86.2% Caucasian, 66% of patients, 36% of partners female]. Patient participants had either breast, colorectal, or lung cancer. Couples individually completed self-report measures of attachment (baseline) and physical well-being (baseline and 4, 8, and 12 months later). At baseline, couples engaged in a 15 min videorecorded cancer-related conversation coded for communication behavior and affective expression. Patients and partners with higher anxious and avoidant attachment exhibited more negative affect and negative approach behaviors. A greater avoidant attachment was associated with less positive affective expression. Attachment insecurity and affective expression were prospectively linked with physical well-being. Findings indicate that attachment is associated with overt communication behaviors and that insecure attachment and affective expression may be risk factors for poorer health outcomes.
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Neoplasias , Comportamento Sexual , Humanos , Feminino , Comportamento Sexual/psicologia , Ansiedade , Adaptação Psicológica , Comunicação , Relações Interpessoais , Apego ao Objeto , Parceiros Sexuais/psicologiaRESUMO
Rationale: Psychological distress symptoms are common among patients recently hospitalized with cardiorespiratory failure, yet there are few effective postdischarge therapies that are relevant to their experiences. Objectives: To determine the feasibility and clinical impact of two different versions of a month-long self-guided mobile app-based coping skills program called Blueprint in comparison to usual care (UC) control. Methods: Patients hospitalized with a serious cardiopulmonary diagnoses were recruited from adult intensive care units and stepdown units at a large academic medical center. Participants with elevated psychological distress symptoms just after discharge were randomized in a 1:1:1 ratio to Blueprint with a therapist (BP/therapist), Blueprint without a therapist (BP/no therapist), or UC control. All study procedures were conducted remotely. Blueprint is a self-guided, symptom-responsive, mobile app-based adaptive coping skills program with 4 themed weeks with different daily audio, video, and text content. Participants completed surveys via the app platform at baseline and 1 and 3 months later. The primary outcome was feasibility. Additional outcomes included the HADS (Hospital Anxiety and Depression Scale) total score, the PTSS (Post-Traumatic Stress Scale), and a 100-point quality of life visual analog scale. Results: Of 63 patients who consented, 45 (71%) with elevated distress were randomized to BP/therapist (n = 16 [36%]), BP/no therapist (n = 14 [31%]), and UC (n = 15 [33%]). Observed rates were similar to target feasibility benchmarks, including consented patients who were randomized (71.4%), retention (75.6%), and intervention adherence (97% with weekly use). Estimated mean differences (95% confidence intervals) at 1 month compared with baseline included: HADS total (BP/therapist, -3.8 [-6.7 to -0.6]; BP/no therapist, -4.2 [-7.6 to -0.0]; UC, -3.4 [-6.6 to 0.2]); PTSS (BP/therapist, -6.7 [-11.3 to -2.1]; BP/no therapist, -9.1 [-14.4 to -3.9]; UC, -4.2 [-10.8 to 2.3]); and quality of life (BP/therapist, -4.5 [-14.3 to 4.6]; BP/no therapist, 14.0 [-0.9 to 29.0]; UC, 8.7 [-3.5 to 20.9]). Conclusions: Among survivors of cardiorespiratory failure, a mobile app-based postdischarge coping skills training intervention demonstrated evidence of feasibility and clinical impact compared with UC control. A larger trial is warranted to test the efficacy of this approach. Clinical trial registered with ClinicalTrials.gov (NCT04329702).
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Aplicativos Móveis , Adulto , Humanos , Assistência ao Convalescente , Qualidade de Vida , Estudos de Viabilidade , Projetos Piloto , Alta do Paciente , Adaptação Psicológica , Sobreviventes/psicologiaRESUMO
Seriously ill patients often experience persistent pain. As a part of a comprehensive repertoire of pain interventions, palliative care clinicians can help by using behavioral pain management. Behavioral pain management refers to evidence-based psychosocial interventions to reduce pain intensity and enhance functional outcomes and quality of life. Conceptualized using the biopsychosocial model, techniques involve promoting helpful behaviors (e.g., activity pacing, stretching, and relaxation exercises) and modifying underlying patterns of thinking, feeling, and communicating that can exacerbate pain. The authors have expertise in pain management, clinical health psychology, geropsychology, behavioral science, and palliative medicine. The article reviews the current evidence for behavioral interventions for persistent pain and provides 10 recommendations for behavioral pain management.
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Enfermagem de Cuidados Paliativos na Terminalidade da Vida , Cuidados Paliativos , Humanos , Manejo da Dor , Qualidade de Vida , DorRESUMO
BACKGROUND: Purposes were to identify subgroups of patients with gastrointestinal cancers with distinct morning and evening fatigue severity profiles and evaluate for differences among these subgroups in demographic and clinical characteristics, co-occurring symptoms and quality of life (QOL) outcomes. METHODS: Patients with gastrointestinal cancers (n=405) completed questionnaires six times over two cycles of chemotherapy. Latent profile analysis was used to identify distinct morning and evening fatigue profiles. Differences in demographic and clinical characteristics, co-occurring symptoms and QOL outcomes among the subgroups were evaluated using parametric and nonparametric tests. RESULTS: Two distinct mornings (ie, low and very high) and three distinct evenings (ie, low, moderate and very high) fatigue classes were identified. Common risk factors for both morning and evening fatigue included younger age, lower performance status, higher comorbidity burden and self-reported depression. Higher levels of morning fatigue were associated with being unmarried, living alone, being unemployed, having a lower income, lack of regular exercise and a self-reported diagnosis of anaemia. Higher levels of evening fatigue were associated with being women, white and having childcare responsibilities. Patients in the very high morning and evening fatigue classes reported higher levels of anxiety, depressive symptoms, sleep disturbance and pain and lower levels of attentional function and poorer QOL. CONCLUSION: Findings provide new insights into risk factors for and deleterious effects of morning and evening fatigue in patients with gastrointestinal cancers. Clinicians can use this information to identify high-risk patients and develop individualised interventions for morning and evening fatigue and other co-occurring symptoms.
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Fadiga , Neoplasias Gastrointestinais , Feminino , Humanos , Masculino , Antineoplásicos/uso terapêutico , Fadiga/etiologia , Neoplasias Gastrointestinais/complicações , Neoplasias Gastrointestinais/tratamento farmacológico , Qualidade de VidaRESUMO
BACKGROUND: The use of digital technologies and software allows for new opportunities to communicate and engage with research participants over time. When software is coupled with automation, we can engage with research participants in a reliable and affordable manner. Research Electronic Data Capture (REDCap), a browser-based software, has the capability to send automated text messages. This feature can be used to automate delivery of tailored intervention content to research participants in interventions, offering the potential to reduce costs and improve accessibility and scalability. OBJECTIVE: This study aimed to describe the development and use of 2 REDCap databases to deliver automated intervention content and communication to index participants and their partners (dyads) in a 2-arm, 24-month weight management trial, Partner2Lose. METHODS: Partner2Lose randomized individuals with overweight or obesity and cohabitating with a partner to a weight management intervention alone or with their partner. Two databases were developed to correspond to 2 study phases: one for weight loss initiation and one for weight loss maintenance and reminders. The weight loss initiation database was programmed to send participants (in both arms) and their partners (partner-assisted arm) tailored text messages during months 1-6 of the intervention to reinforce class content and support goal achievement. The weight maintenance and reminder database was programmed to send maintenance-related text messages to each participant (both arms) and their partners (partner-assisted arm) during months 7-18. It was also programmed to send text messages to all participants and partners over the course of the 24-month trial to remind them of group classes, dietary recall and physical activity tracking for assessments, and measurement visits. All text messages were delivered via Twilio and were unidirectional. RESULTS: Five cohorts, comprising 231 couples, were consented and randomized in the Partner2Lose trial. The databases will send 53,518 automated, tailored text messages during the trial, significantly reducing the need for staff to send and manage intervention content over 24 months. The cost of text messaging will be approximately US $450. Thus far, there is a 0.004% known error rate in text message delivery. CONCLUSIONS: Our trial automated the delivery of tailored intervention content and communication using REDCap. The approach described provides a framework that can be used in future behavioral health interventions to create an accessible, reliable, and affordable method for intervention delivery and engagement that requires minimal trial-specific resources and personnel time. TRIAL REGISTRATION: ClinicalTrials.gov NCT03801174; https://clinicaltrials.gov/ct2/show/NCT03801174?term=NCT03801174.
RESUMO
BACKGROUND: For patients and their intimate partners, advanced cancer poses significant challenges that can negatively impact both individuals and their relationship. Prior studies have found evidence that couple-based communication skills interventions can to be beneficial for patients and partners. However, these studies have been limited by reliance on in-person treatment delivery and have not targeted couples at high risk for poor outcomes. This study tests the efficacy of a Couples Communication Skills Training (CCST) intervention delivered via videoconference for couples reporting high levels of holding back from discussing cancer-related concerns, a variable associated with poorer psychological and relationship functioning. METHODS: This RCT is designed to evaluate the efficacy of CCST in improving patient and partner relationship functioning (primary outcome). Secondary outcomes include patient and partner psychological functioning and patient symptoms and health care use. We also examine the role of objective and self-reported communication behaviors as mediators of treatment effects. Two hundred thirty patients with advanced lung, gastrointestinal, genitourinary, and breast cancer and their partners will be randomized to CCST or an education control intervention. Participants in both conditions complete self-reported outcome measures at baseline, mid-treatment, post-treatment, and 3 months post-treatment. Objective measures of communication are derived from video-recorded couple conversations collected at baseline and post-treatment. An implementation-related process evaluation (assessing implementation outcomes and potential barriers to/facilitators of implementation) will be conducted to inform future efforts to implement CCST in real-world settings. DISCUSSION: This trial can yield important new knowledge about effective ways to improve patient and partner adjustment to advanced cancer. TRIAL REGISTRATION: This study trial is registered at clinicaltrials.gov (Trial # NCT04590885); registration date: October 19, 2020.