Distinguishing Clinical From Statistical Significances in Contemporary Comparative Effectiveness Research.

OBJECTIVE: To determine the prevalence of clinical significance reporting in contemporary comparative effectiveness research (CER). BACKGROUND: In CER, a statistically significant difference between study groups may or may not be clinically significant. Misinterpreting statistically significant results could lead to inappropriate recommendations that increase health care costs and treatment toxicity. METHODS: CER studies from 2022 issues of the Annals of Surgery , Journal of the American Medical Association , Journal of Clinical Oncology , Journal of Surgical Research , and Journal of the American College of Surgeons were systematically reviewed by 2 different investigators. The primary outcome of interest was whether the authors specified what they considered to be a clinically significant difference in the "Methods." RESULTS: Of 307 reviewed studies, 162 were clinical trials and 145 were observational studies. Authors specified what they considered to be a clinically significant difference in 26 studies (8.5%). Clinical significance was defined using clinically validated standards in 25 studies and subjectively in 1 study. Seven studies (2.3%) recommended a change in clinical decision-making, all with primary outcomes achieving statistical significance. Five (71.4%) of these studies did not have clinical significance defined in their methods. In randomized controlled trials with statistically significant results, sample size was inversely correlated with effect size ( r = -0.30, P = 0.038). CONCLUSIONS: In contemporary CER, most authors do not specify what they consider to be a clinically significant difference in study outcome. Most studies recommending a change in clinical decision-making did so based on statistical significance alone, and clinical significance was usually defined with clinically validated standards.

Group Coping Intervention in Patients With Chronic Graft-Versus-Host Disease: A Pilot Randomized Clinical Trial.

BACKGROUND: More than half the long-term survivors of allogeneic hematopoietic cell transplantation develop chronic graft-versus-host disease (GVHD), a debilitating inflammatory syndrome. Supportive interventions to assist survivors in coping with chronic GVHD are critically needed. PATIENTS AND METHODS: We conducted a pilot randomized clinical trial of a multidisciplinary group intervention (Horizons Program; n=39) versus minimally enhanced usual care (n=41) for patients with moderate or severe chronic GVHD. Horizons participants received 8 weekly sessions about GVHD and coping co-led by a transplant clinician and a behavioral health expert via a secure videoconferencing platform. Participants completed the following surveys before randomization, at 10 weeks, and at 18 weeks: Functional Assessment of Cancer Therapy-Bone Marrow Transplant Scale (FACT-BMT) for quality of life (QoL), Lee Symptom Scale for symptom burden, and Hospital Anxiety and Depression Scale-Depression Symptoms (HADS) for mood. The primary endpoint was feasibility (≥50% enrollment, ≥80% attendance in half the sessions for the Horizons arm only, and ≥80% retention). We also explored preliminary efficacy of the Horizons intervention on changes in patient-reported outcomes with linear mixed effects models and estimates of effect size at 10 weeks. RESULTS: We enrolled and registered 80 (67.2%) of 119 eligible patients (mean age, 62 years; 48.8% female). Of the participants in the Horizons Program, 84.6% attended at least half the sessions. Of registered participants, 91.3% completed assessment follow-ups (Horizons, 35/39 [89.7%]; minimally enhanced usual care, 38/41 [92.7%]). Horizons participants reported improvements in QoL (b = 2.24; d=0.53), anxiety symptoms (b = -0.10; d=0.34), and depression symptoms (b = -0.71; d=0.44) compared with participants who received minimally enhanced usual care. CONCLUSIONS: Participation in a multidisciplinary group intervention study was feasible for patients with chronic GVHD, with promising signals for improving QoL and mood. A full-scale efficacy trial is needed to confirm effects on patient-reported outcomes.

Learning about and living with toxicity: a qualitative study of patients receiving immune checkpoint inhibitors for melanoma or lung cancer and their caregivers.

BACKGROUND/OBJECTIVE: Immune checkpoint inhibitors (ICIs) have revolutionized treatment for melanoma and lung cancer and are in widespread use. This study aims to describe how patients and caregivers learn about ICI toxicities and their perceptions and experiences of toxicity. METHODS: We conducted a qualitative study of 42 patients with advanced non-small cell lung cancer (NSCLC; n = 16) or melanoma (n = 26) who were initiating or discontinuing an ICI and their caregivers (n = 9). We conducted in-depth interviews to explore patients' and caregivers' experiences learning about and living with ICI side effects. We audio-recorded the first oncology visit after enrollment. We used a framework approach to code interview and visit transcripts and synthesized codes into themes. RESULTS: The median age of patients was 67; 68% were male. Themes of participant interviews and clinician-patient dialogue included: (i) Patients initiating an ICI received extensive information about side effects, which some patients found overwhelming or scary and difficult to absorb; (ii) patients who were deterred by fear of toxicity ultimately proceeded with treatment because of oncologist encouragement or the sense of no alternative; (iii) participants found hope in the association between toxicity and ICI efficacy; (iv) caregivers helped patients navigate the deluge of information and uncertainty related to ICIs. Participants suggested ways to improve ICI side effect education, such as incorporating patient stories. CONCLUSION: Patients perceived that ICI toxicity counseling was overwhelming yet were encouraged by oncologists' reassurance that serious side effects were manageable and by the framing of toxicity as a sign of efficacy. We identified opportunities to improve communication of ICI risks and benefits.

Psychological mobile app for patients with acute myeloid leukemia: A pilot randomized clinical trial.

BACKGROUND: Patients with acute myeloid leukemia (AML) experience a substantial decline in quality of life (QoL) and mood during their hospitalization for intensive chemotherapy, yet few interventions have been developed to enhance patient-reported outcomes during treatment. METHODS: We conducted a pilot randomized trial (ClinicalTrials.gov identifier NCT03372291) of DREAMLAND, a psychological mobile application for patients with a new diagnosis of AML who are receiving intensive chemotherapy. Patients were randomly assigned to DREAMLAND or usual care. DREAMLAND included four required modules focused on: (1) supportive psychotherapy to help patients deal with the initial shock of diagnosis, (2) psychoeducation to manage illness expectations, (3) psychosocial skill-building to promote effective coping, and (4) self-care. The primary end point was feasibility, which was defined as ≥60% of eligible patients enrolling and 60% of those enrolled completing ≥60% of the required modules. We assessed patient QoL (the Functional Assessment of Cancer Therapy-Leukemia), psychological distress (the Hospital Anxiety and Depression Scale and the Patient Health Questionnaire-9), symptom burden (the Edmonton Symptom Assessment Scale), and self-efficacy (the Cancer Self-Efficacy Scale) at baseline and at day 20 after postchemotherapy. RESULTS: We enrolled 60 of 90 eligible patients (66.7%), and 62.1% completed ≥75% of the intervention modules. At day 20 after chemotherapy, patients who were randomized to DREAMLAND reported improved QoL scores (132.06 vs. 110.72; p =.001), lower anxiety symptoms (3.54 vs. 5.64; p = .010) and depression symptoms (Hospital Anxiety and Depression Scale: 4.76 vs. 6.29; p = .121; Patient Health Questionnaire-9: 4.62 vs. 8.35; p < .001), and improved symptom burden (24.89 vs. 40.60; p = .007) and self-efficacy (151.84 vs. 135.43; p = .004) compared with the usual care group. CONCLUSIONS: A psychological mobile application for patients with newly diagnosed AML is feasible to integrate during hospitalization for intensive chemotherapy and may improve QoL, mood, symptom burden, and self-efficacy.

Do cancer curvivors and metavivors have distinct needs for stress management intervention? Retrospective analysis of a mind-body survivorship program.

PURPOSE: Cancer "curvivors" (completed initial curative intent treatment with surgery, radiation, chemotherapy, and/or other novel therapies) and "metavivors" (living with metastatic or chronic, incurable cancer) experience unique stressors, but it remains unknown whether these differences impact benefits from mind-body interventions. This study explored differences between curvivors and metavivors in distress (depression, anxiety, worry) and resiliency changes over the course of an 8-week group program, based in mind-body stress reduction, cognitive-behavioral therapy (CBT), and positive psychology. METHODS: From 2017-2021, 192 cancer survivors (83% curvivors; 17% metavivors) completed optional online surveys of resiliency (CES) and distress (PHQ-8, GAD-7, PSWQ-3) pre- and post- participation in an established clinical program. Mixed effect regression models explored curvivor-metavivor differences at baseline and in pre-post change. RESULTS: Compared to curvivors, metavivors began the program with significantly more resilient health behaviors (B = 0.99, 95% CI[0.12, 1.86], p = .03) and less depression (B = -2.42, 95%CI[-4.73, -0.12], p = .04), with no other significant differences. Curvivors experienced significantly greater reductions in depression (curvivor-metavivor difference in strength of change = 2.12, 95% CI [0.39, 3.83], p = .02) over the course of the program, with no other significant differences. Neither virtual delivery modality nor proportion of sessions attended significantly moderated strength of resiliency or distress change. CONCLUSION: Metavivors entering this mind-body program had relatively higher well-being than did curvivors, and both groups experienced statistically comparable change in all domains other than depression. Resiliency programming may thus benefit a variety of cancer survivors, including those living with incurable cancer.

Prognostic communication about lung cancer in the precision oncology era: A multiple-perspective qualitative study.

BACKGROUND: Although most patients with cancer prefer to know their prognosis, prognostic communication between oncologists and patients is often insufficient. Targeted therapies for lung cancer improve survival yet are not curative and produce variable responses. This study sought to describe how oncologists communicate about prognosis with patients receiving targeted therapies for lung cancer. METHODS: This qualitative study included 39 patients with advanced lung cancer with targetable mutations, 14 caregivers, and 10 oncologists. Semistructured interviews with patients and caregivers and focus groups or interviews with oncologists were conducted to explore their experiences with prognostic communication. One oncology follow-up visit was audio-recorded per patient. A framework approach was used to analyze interview transcripts, and a content analysis of patient-oncologist dialogue was conducted. Themes were identified within each source and then integrated across sources to create a multidimensional description of prognostic communication. RESULTS: Six themes in prognostic communication were identified: Patients with targetable mutations develop a distinct identity in the lung cancer community that affects their information-seeking and self-advocacy; oncologists set high expectations for targeted therapy; the uncertain availability of new therapies complicates prognostic discussions; patients and caregivers have variable information preferences; patients raise questions about progression by asking about physical symptoms or scan results; and patients' expectations of targeted therapy influence their medical decision-making. CONCLUSIONS: Optimistic patient-oncologist communication shapes the expectations of patients receiving targeted therapy for lung cancer and affects their decision-making. Further research and clinical guidance are needed to help oncologists to communicate uncertain outcomes effectively.

Perceptions of somatic and affective symptoms and psychosocial care utilization in younger and older survivors of lung cancer.

OBJECTIVE: Rates of depression identification in oncology settings and referral to psychosocial services remain low. Patients with lung cancer face an elevated risk of depression relative to patients with other cancers. This study explored perceptions of somatic and affective symptoms and psychosocial care utilization among younger and older lung cancer survivors. METHODS: We conducted in-depth interviews with 20 adults at two academic medical centers in Boston, MA, who had received a lung cancer diagnosis in the past 24 months. A semi-structured interview guide was used to assess experiences with, and perceptions of, depression symptoms and psychosocial services. Interviews were audio-recorded, transcribed, and coded to identify themes. We also explored differences between younger (<65years; N=9) and older (>65years; N=11) patients. RESULTS: Participants commonly described somatic symptoms (i.e., changes in appetite, sleep, or energy levels) and affective symptoms (i.e., worry, fear, sadness) as side effects of cancer treatment. Older participants more commonly contextualized these symptoms with information about how they impacted daily life. Both younger and older participants faced barriers to accessing psychosocial services, with older adults more commonly referencing stigma of service referral and utilization. DISCUSSION: Patients with lung cancer associated both somatic and affective symptoms with their cancer and its treatment, with age differences in how symptoms were described and how psychosocial referrals may be perceived. More systematic integration of psychosocial care into cancer care may help to increase the identification of depression in lung cancer and reduce barriers to psychosocial service utilization.

Implementation of competence by design in Canadian neurosurgery residency programs.

OBJECTIVE: The Royal College of Physicians and Surgeons of Canada (RCPSC) recently redesigned the Canadian neurosurgery residency training curriculum by implementing a competency-based model of training known as Competence by Design (CBD) centered around the assessment of Entrustable Professional Activities (EPAs). This sequential explanatory mixed-methods study evaluated potential benefits and pitfalls of CBD in Canadian neurosurgery residency education. METHODS: Two four-month interval surveys were distributed to all Canadian neurosurgery residents participating in CBD. The surveys assessed important educational components: CBD knowledge of key stakeholders, potential system barriers, and educational/psychological impacts on residents. Paired t-tests were done to assess changes over time. Based on longitudinal survey responses, semi-structured interviews were conducted to investigate in-depth residents' experience with CBD in neurosurgery. The qualitative analysis followed an explanatory approach, and a thematic analysis was performed. RESULTS: Surveys had 82% average response rate (n = 25). Over time, most residents self-reported that they retrospectively understood concepts around CBD intentions (p = 0.02). Perceived benefits included faculty evaluations with more feedback that was clearer and more objective (53% and 51%). Pitfalls included the amount of time needed to navigate through EPAs (90%) and residents forgetting to initiate EPA forms (71%). There was no significant change over time. During interviews, five key themes were found. Potential solutions identified by residents to enhance their experience included learning analytics data availability, mobile app refinement, and dedicated time to integrate EPAs in the workflow. CONCLUSION: This study was the first to assess resident-perceived benefits and pitfalls of the neurosurgery CBD training program in an educational framework context. In general, residents believed that theoretical principles behind CBD were valuable, but that technological ability and having enough time to request EPA assessments were significant barriers to success. Long-term studies are required to determine the definitive outcomes of CBD on residents' performance and ultimately, on patient care.

Palliative care in the emergency department: A qualitative study exploring barriers, facilitators, desired clinician qualities, and future directions.

OBJECTIVE: To describe the perceived qualities of successful palliative care (PC) providers in the emergency department (ED), barriers and facilitators to ED-PC, and clinicians' perspectives on the future of ED-PC. METHOD: This qualitative study using semi-structured interviews was conducted in June-August 2020. Interviews were analyzed via a two-phase Rapid Analysis. The study's primary outcomes (innovations in ED-PC during COVID) are published elsewhere. In this secondary analysis, we examine interviewee responses to broader questions about ED-PC currently and in the future. RESULTS: PC providers perceived as successful in their work in the ED were described as autonomous, competent, flexible, fast, and fluent in ED language and culture. Barriers to ED-PC integration included the ED environment, lack of access to PC providers at all times, the ED perception of PC, and the lack of a supporting financial model. Facilitators to ED-PC integration included proactive identification of patients who would benefit from PC, ED-focused PC education and tools, PC presence in the ED, and data supporting ED-PC. Increased primary PC education for ED staff, increased automation, and innovative ED-PC models were seen as areas for future growth. SIGNIFICANCE OF RESULTS: Our findings provide useful information for PC programs considering expanding their ED presence, particularly as this is the first study to our knowledge that examines traits of successful PC providers in the ED environment. Our findings also suggest that, despite growth in the arena of ED-PC, barriers and facilitators remain similar to those identified previously. Future research is needed to evaluate the impact that ED-PC initiatives may have on patient and system outcomes, to identify a financial model to maintain ED-PC integration, and to examine whether perceptions of successful providers align with objective measures of the same.

Sharing and caring: The impact of social support on quality of life and health outcomes in hematopoietic stem cell transplantation.

BACKGROUND: Social support is crucial for successful recovery after hematopoietic stem cell transplantation (HSCT) and has the potential to affect patient quality of life (QOL) and health outcomes. However, there are limited data on the relationship between a patient's perception of his or her social support and these outcomes. METHODS: The authors conducted a secondary analysis of 250 autologous and allogeneic HSCT recipients enrolled in 2 supportive care trials at Massachusetts General Hospital from April 2011 through February 2016. They assessed social support as a patient's perception of his or her social well-being via the social well-being subscale of the Functional Assessment of Cancer Therapy. The authors used multivariate regression analyses to examine the relationship between pretransplant social well-being and QOL (Functional Assessment of Cancer Therapy-Treatment Outcome Index), psychological distress (Hospital Anxiety and Depression Scale), posttraumatic stress disorder [PTSD] symptoms (PTSD Checklist), fatigue (Functional Assessment of Cancer Therapy-Fatigue), and health care utilization (hospitalizations and days alive and out of the hospital) 6 months after HSCT. RESULTS: Participants were on average 56.4 years old (SD, 13.3 years); 44% (n = 110) and 56% (n = 140) received autologous and allogeneic HSCT, respectively. Greater pre-HSCT social well-being was associated with higher QOL (B = 0.10; 95% CI, 0.06-0.13; P < .001), lower psychological distress (B = -0.21; 95% CI, -0.29 to -0.12; P < .001), and lower PTSD symptoms (B = -0.12; 95% CI, -0.19 to -0.06; P < .001). Pre-HSCT social well-being was not significantly associated with fatigue or health care utilization 6 months after HSCT. CONCLUSIONS: Patients with higher pre-HSCT perceptions of their social support reported better QOL and lower psychological distress 6 months after HSCT. These findings underscore the potential for social support as a modifiable target for future supportive care interventions to improve the QOL and care of HSCT recipients.

Posttraumatic stress disorder symptoms in patients with acute myeloid leukemia.

BACKGROUND: Patients with acute myeloid leukemia (AML) receiving intensive chemotherapy face a life-threatening illness, isolating hospitalization, and substantial physical and psychological symptoms. However, data are limited regarding risk factors of posttraumatic stress disorder (PTSD) symptoms in this population. METHODS: The authors conducted a secondary analysis of data from 160 patients with high-risk AML who were enrolled in a supportive care trial. The PTSD Checklist-Civilian Version was used to assess PTSD symptoms at 1 month after AML diagnosis. The Brief COPE and the Functional Assessment of Cancer Therapy-Leukemia were to assess coping and quality of life (QOL), respectively. In addition, multivariate regression models were constructed to assess the relation between PTSD symptoms and baseline sociodemographic factors, coping, and QOL. RESULTS: Twenty-eight percent of patients reported PTSD symptoms, describing high rates of intrusion, avoidance, and hypervigiliance. Baseline sociodemographic factors significantly associated with PTSD symptoms were age (B = -0.26; P = .002), race (B = -8.78; P = .004), and postgraduate education (B = -6.30; P = .029). Higher baseline QOL (B = -0.37; P ≤ .001) and less decline in QOL during hospitalization (B = -0.05; P = .224) were associated with fewer PTSD symptoms. Approach-oriented coping (B = -0.92; P = .001) was associated with fewer PTSD symptoms, whereas avoidant coping (B = 2.42; P ≤ .001) was associated with higher PTSD symptoms. CONCLUSIONS: A substantial proportion of patients with AML report clinically significant PTSD symptoms 1 month after initiating intensive chemotherapy. Patients' baseline QOL, coping strategies, and extent of QOL decline during hospitalization emerge as important risk factors for PTSD, underscoring the need for supportive oncology interventions to reduce the risk of PTSD in this population.

Simulated Volume-Based Regionalization of Complex Procedures: Impact on Spatial Access to Care.

OBJECTIVE: This study simulates the regionalization of pancreatectomies to assess its impact on spatial access in terms of patient driving times. BACKGROUND: Although policies to regionalize complex procedures to high-volume centers may improve outcomes, the impact on patient access is unknown. METHODS: Patients who underwent pancreatectomies from 2005 to 2014 were identified from California's statewide database. Round-trip driving times between patients' home ZIP code and hospital addresses were calculated via Google Maps. Regionalization was simulated by eliminating hospitals performing <20 pancreatectomies/yr, and reassigning patients to the next closest hospital that satisfied the volume threshold. Sensitivity analyses were performed for New York and Medicare patients to assess for influence of geography and insurance coverage, respectively. RESULTS: Of 13,317 pancreatectomies, 6335 (47.6%) were performed by hospitals with <20 cases/yr. Patients traveled a median of 49.8 minutes [interquartile range (IQR) 30.8-96.2] per round-trip. A volume-restriction policy would increase median round-trip driving time by 24.1 minutes (IQR 4.5-53.5). Population in-hospital mortality rates were estimated to decrease from 6.7% to 2.8% (P < 0.001). Affected patients were more likely to be racial minorities (44.6% vs 36.5% of unaffected group, P < 0.001) and covered by Medicaid or uninsured (16.3% vs 9.8% of unaffected group, P < 0.001). Sensitivity analyses revealed a 17.8 minutes increment for patients in NY (IQR 0.8-47.4), and 27.0 minutes increment for Medicare patients (IQR 6.2-57.1). CONCLUSIONS: A policy that limits access to low-volume pancreatectomy hospitals will increase round-trip driving time by 24 minutes, but up to 54 minutes for 25% of patients. Population mortality rates may improve by 1.5%.

Patient and Caregiver Considerations and Priorities When Selecting Hospitals for Complex Cancer Care.

BACKGROUND: Healthcare policies have focused on centralizing care to high-volume centers in an effort to optimize patient outcomes; however, little is known about patients' and caregivers' considerations and selection process when selecting hospitals for care. We aim to explore how patients and caregivers select hospitals for complex cancer care and to develop a taxonomy for their selection considerations. METHODS: This was a qualitative study in which data were gathered from in-depth interviews conducted from March to November 2019 among patients with hepatopancreatobiliary cancers who were scheduled to undergo a pancreatectomy (n = 20) at a metropolitan, urban regional, or suburban medical center and their caregivers (n = 10). RESULTS: The interviews revealed six broad domains that characterized hospital selection considerations: hospital factors, team characteristics, travel distance to hospital, referral or recommendation, continuity of care, and insurance considerations. The identified domains were similar between participants seen at the metropolitan center and urban/suburban medical centers, with the following exceptions: participants receiving care specifically at the metropolitan center noted operative volume and access to specific services such as clinical trials in their hospital selection; participants receiving care at urban/suburban centers noted health insurance considerations and having access to existing medical records in their hospital selection. CONCLUSIONS: This study delineates the many considerations of patients and caregivers when selecting hospitals for complex cancer care. These identified domains should be incorporated into the development and implementation of centralization policies to help increase patient access to high-quality cancer care that is consistent with their priorities and needs.

Burdensome Transitions of Care for Patients with End-Stage Liver Disease and Their Caregivers.

BACKGROUND: Patients with end-stage liver disease (ESLD) experience frequent readmissions; however, studies focused on patients' and caregivers' perceptions of their transitional care experiences to identify root causes of burdensome transitions of care are lacking. AIM: To explore the transitional care experiences of patients with ESLD and their caregivers in order to identify their supportive care needs. METHODS: We conducted interviews with 15 patients with ESLD and 14 informal caregivers. We used semi-structured interview guides to explore their experiences since the diagnosis of ESLD including their care transitions. Two raters coded interviews independently (κ = 0.95) using template analysis. RESULTS: Participants reported feeling unprepared to manage their informational, psychosocial, and practical care needs as they transitioned from hospital to home after the diagnosis of ESLD. Delay in the timely receipt of supportive care services addressing these care needs resulted in hospital readmissions, emotional distress, caregiver burnout, reduced work capacity, and financial hardship. Participants shared the following resources that they perceived would improve their quality of care: (1) discharge checklist, (2) online resources, (3) mental health support, (4) caregiver support and training, and (5) financial navigation. CONCLUSION: Transitional care models that attend to the informational, psychosocial, and practical domains of care are needed to better support patients with ESLD and their caregivers at the time of diagnosis and beyond. Without attending to the multidimensional care needs of newly diagnosed patients with ESLD and their caregivers, they are at risk of burdensome transitions of care, high healthcare utilization, and poor health-related quality of life.

Enhanced coping and self-efficacy in caregivers of stem cell transplant recipients: Identifying mechanisms of a multimodal psychosocial intervention.

BACKGROUND: In a recent trial, a 6-session intervention (BMT-CARE) integrating medical information with cognitive-behavioral strategies improved quality of life (QOL), mood, coping skills, and self-efficacy for family/friend caregivers of hematopoietic stem cell transplantation (HCT) recipients. This study examined whether improvements in coping and self-efficacy mediated the intervention effects on QOL and mood. METHODS: From December 2017 to April 2019, 100 caregivers of HCT recipients were enrolled into a randomized clinical trial of BMT-CARE versus usual care. Caregivers completed self-report measures of QOL (CareGiver Oncology Quality of Life questionnaire), depression and anxiety symptoms (Hospital Anxiety and Depression Scale), coping skills (Measure of Current Status), and self-efficacy (Cancer Self-Efficacy Scale-Transplant) at enrollment (before HCT) and 60 days after HCT. Causal mediation regression models were used to examine whether changes in coping and self-efficacy mediated intervention effects on QOL as well as depression and anxiety symptoms. RESULTS: Improvements in 60-day QOL in patients assigned to BMT-CARE were partially mediated by improved coping and self-efficacy (indirect effect, 6.93; SE, 1.85; 95% CI, 3.71-11.05). Similarly, reductions in 60-day depression and anxiety symptoms were partially mediated by improved coping and self-efficacy (indirect effect for depression, -1.19; SE, 0.42; 95% CI, -2.23 to -0.53; indirect effect for anxiety, -1.46; SE, 0.55; 95% CI, -2.52 to -0.43). Combined improvements in coping and self-efficacy accounted for 67%, 80%, and 39% of the total intervention effects on QOL and depression and anxiety symptoms, respectively. CONCLUSIONS: Coping and self-efficacy are essential components of a brief psychosocial intervention that improves QOL and mood for caregivers of HCT recipients during the acute recovery period. LAY SUMMARY: A 6-session program (BMT-CARE) focused on providing medical information, caregiving skills, and self-care and coping strategies has been previously reported to improve the quality of life and mood of caregivers of hematopoietic stem cell transplantation recipients in comparison with caregivers who receive care as usual. Using statistical models, this study suggests that learning coping skills and improving self-efficacy are the most essential components of this program that likely lead to better quality of life and mood for caregivers.

Randomized trial of a hospice video educational tool for patients with advanced cancer and their caregivers.

BACKGROUND: Patients with advanced cancer and their caregivers have substantial misperceptions regarding hospice, which contributes to its underuse. METHODS: The authors conducted a single-site randomized trial of a video educational tool versus a verbal description of hospice in 150 hospitalized patients with advanced cancer and their caregivers. Patients without a caregiver were eligible. Intervention participants (75 patients and 18 caregivers) viewed a 6-minute video depicting hospice. Control participants (75 patients and 26 caregivers) received a verbal description identical to the video narrative. The primary outcome was patient preference for hospice. Secondary outcomes included patient and/or caregiver knowledge and perceptions of hospice, and hospice use. RESULTS: Between February 2017 and January 2019, approximately 55.7% of eligible patients (150 of 269 eligible patients) and 44 caregivers were enrolled. After the intervention, there was no difference noted with regard to patients' preferences for hospice (86.7% vs 82.7%; P = .651). Patients in the video group reported greater knowledge regarding hospice (9.0 vs 8.4; P = .049) and were less likely to endorse that hospice is only about death (6.7% vs 21.6%; P = .010). Among deceased patients, those assigned to the intervention were more likely to have used hospice (85.2% vs 63.6%; P = .01) and to have had a longer hospice length of stay (median, 12 days vs 3 days; P < .001). After the intervention, caregivers assigned to view the video were more likely to prefer hospice for their loved ones (94.4% vs 65.4%; P = .031), reported greater knowledge concerning hospice (9.7% vs 8.0%; P = .001), and were less likely to endorse that hospice is only about death (0.0% vs 23.1%; P = .066). CONCLUSIONS: A hospice video did not significantly impact patients' preferences for hospice care. Patients with advanced cancer and their caregivers who were assigned to view the video were more informed regarding hospice and reported more favorable perceptions of hospice. Patients were more likely to use hospice and to have a longer hospice length of stay.

Multimodal psychosocial intervention for family caregivers of patients undergoing hematopoietic stem cell transplantation: A randomized clinical trial.

BACKGROUND: Caregivers of patients undergoing hematopoietic stem cell transplantation (HCT) experience an immense caregiving burden before, during, and after HCT. METHODS: We conducted an unblinded, randomized trial of a psychosocial intervention (BMT-CARE) for caregivers of patients undergoing autologous and allogeneic HCT at Massachusetts General Hospital. Caregivers were randomly assigned to BMT-CARE or usual care. BMT-CARE was tailored to the HCT trajectory and integrated treatment-related education and self-care with cognitive-behavioral skills to promote coping. Caregivers assigned to BMT-CARE met with a trained interventionist (a psychologist or a social worker) in person, via telephone, or via videoconferencing for 6 sessions starting before HCT and continuing up to day +60 after HCT. The primary endpoint was feasibility, which was defined as at least 60% of eligible caregivers enrolling and completing 50% or more of the intervention sessions. We assesed caregiver quality of life (QOL; Caregiver Oncology Quality of Life Questionnaire), caregiving burden (Caregiver Reaction Assessment), psychological distress (Hospital Anxiety and Depression Scale), self-efficacy (Cancer Self-Efficacy Scale-Transplant), and coping (Measures of Current Status) at baseline and 30 and 60 days after HCT. We used mixed linear effect models to assess the effect of BMT-CARE on outcomes longitudinally. RESULTS: We enrolled 72.5% of eligible caregivers (100 of 138), and 80% attended 50% or more of the intervention sessions. Caregivers randomized to BMT-CARE reported improved QOL (B = 6.11; 95% CI, 3.50-8.71; P < .001), reduced caregiving burden (B = -6.02; 95% CI, -8.49 to -3.55; P < .001), lower anxiety (B = -2.18; 95% CI, -3.07 to -1.28; P < .001) and depression symptoms (B = -1.23; 95% CI, -1.92 to -0.54; P < .001), and improved self-efficacy (B = 7.22; 95% CI, 2.40-12.03; P = .003) and coping skills (B = 4.83; 95% CI, 3.04-6.94; P < .001) in comparison with the usual-care group. CONCLUSIONS: A brief multimodal psychosocial intervention tailored for caregivers of HCT recipients is feasible and may improve QOL, mood, coping, and self-efficacy while reducing the caregiving burden during the acute HCT period.

Relationship Between Perceptions of Treatment Goals and Psychological Distress in Patients With Advanced Cancer.

BACKGROUND: Studies have shown gaps in prognostic understanding among patients with cancer. However, few studies have explored patients' perceptions of their treatment goals versus how they perceive their oncologist's goals, and the association of these views with their psychological distress. METHODS: We conducted a cross-sectional study of 559 patients with incurable lung, gastrointestinal, breast, and brain cancers. The Prognosis and Treatment Perception Questionnaire was used to assess patients' reports of their treatment goal and their oncologist's treatment goal, and the Hospital Anxiety and Depression Scale was used to assess patients' psychological symptoms. RESULTS: We found that 61.7% of patients reported that both their treatment goal and their oncologist's treatment goal were noncurative, whereas 19.3% reported that both their goal and their oncologist's goal were to cure their cancer, 13.9% reported that their goal was to cure their cancer whereas their oncologist's goal was noncurative, and 5% reported that their goal was noncurative whereas their oncologist's goal was curative. Patients who reported both their goal and their oncologist's goal as noncurative had higher levels of depression (B=0.99; P=.021) and anxiety symptoms (B=1.01; P=.015) compared with those who reported that both their goal and their oncologist's goal was curative. Patients with discordant perceptions of their goal and their oncologist's goal reported higher anxiety symptoms (B=1.47; P=.004) compared with those who reported that both their goal and their oncologist's goal were curative. CONCLUSIONS: One-fifth of patients with incurable cancer reported that both their treatment goal and their oncologist's goal were to cure their cancer. Patients who acknowledged the noncurative intent of their treatment and those who perceived that their treatment goal was discordant from that of their oncologist reported greater psychological distress.

Pilot Randomized Trial of a Transdisciplinary Geriatric and Palliative Care Intervention for Older Adults With Cancer.

BACKGROUND: Oncologists often struggle with managing the unique care needs of older adults with cancer. This study sought to determine the feasibility of delivering a transdisciplinary intervention targeting the geriatric-specific (physical function and comorbidity) and palliative care (symptoms and prognostic understanding) needs of older adults with advanced cancer. METHODS: Patients aged ≥65 years with incurable gastrointestinal or lung cancer were randomly assigned to a transdisciplinary intervention or usual care. Those in the intervention arm received 2 visits with a geriatrician, who addressed patients' palliative care needs and conducted a geriatric assessment. We predefined the intervention as feasible if >70% of eligible patients enrolled in the study and >75% of eligible patients completed study visits and surveys. At baseline and week 12, we assessed patients' quality of life (QoL), symptoms, and communication confidence. We calculated mean change scores in outcomes and estimated intervention effect sizes (ES; Cohen's d) for changes from baseline to week 12, with 0.2 indicating a small effect, 0.5 a medium effect, and 0.8 a large effect. RESULTS: From February 2017 through June 2018, we randomized 62 patients (55.9% enrollment rate [most common reason for refusal was feeling too ill]; median age, 72.3 years; cancer types: 56.5% gastrointestinal, 43.5% lung). Among intervention patients, 82.1% attended the first visit and 79.6% attended both. Overall, 89.7% completed all study surveys. Compared with usual care, intervention patients had less QoL decrement (-0.77 vs -3.84; ES = 0.21), reduced number of moderate/severe symptoms (-0.69 vs +1.04; ES = 0.58), and improved communication confidence (+1.06 vs -0.80; ES = 0.38). CONCLUSIONS: In this pilot trial, enrollment exceeded 55%, and >75% of enrollees completed all study visits and surveys. The transdisciplinary intervention targeting older patients' unique care needs showed encouraging ES estimates for enhancing patients' QoL, symptom burden, and communication confidence.

Screening Tool Identifies Older Adults With Cancer at Risk for Poor Outcomes.

BACKGROUND: Oncologists often struggle with managing the complex issues unique to older adults with cancer, and research is needed to identify patients at risk for poor outcomes. METHODS: This study enrolled patients aged ≥70 years within 8 weeks of a diagnosis of incurable gastrointestinal cancer. Patient-reported surveys were used to assess vulnerability (Vulnerable Elders Survey [scores ≥3 indicate a positive screen for vulnerability]), quality of life (QoL; EORTC Quality of Life of Cancer Patients questionnaire [higher scores indicate better QoL]), and symptoms (Edmonton Symptom Assessment System [ESAS; higher scores indicate greater symptom burden] and Geriatric Depression Scale [higher scores indicate greater depression symptoms]). Unplanned hospital visits within 90 days of enrollment and overall survival were evaluated. We used regression models to examine associations among vulnerability, QoL, symptom burden, hospitalizations, and overall survival. RESULTS: Of 132 patients approached, 102 (77.3%) were enrolled (mean [M] ± SD age, 77.25 ± 5.75 years). Nearly half (45.1%) screened positive for vulnerability, and these patients were older (M, 79.45 vs 75.44 years; P=.001) and had more comorbid conditions (M, 2.13 vs 1.34; P=.017) compared with nonvulnerable patients. Vulnerable patients reported worse QoL across all domains (global QoL: M, 53.26 vs 66.82; P=.041; physical QoL: M, 58.95 vs 88.24; P<.001; role QoL: M, 53.99 vs 82.12; P=.001; emotional QoL: M, 73.19 vs 85.76; P=.007; cognitive QoL: M, 79.35 vs 92.73; P=.011; social QoL: M, 59.42 vs 82.42; P<.001), higher symptom burden (ESAS total: M, 31.05 vs 15.00; P<.001), and worse depression score (M, 4.74 vs 2.25; P<.001). Vulnerable patients had a higher risk of unplanned hospitalizations (hazard ratio, 2.38; 95% CI, 1.08-5.27; P=.032) and worse overall survival (hazard ratio, 2.26; 95% CI, 1.14-4.48; P=.020). CONCLUSIONS: Older adults with cancer who screen positive as vulnerable experience a higher symptom burden, greater healthcare use, and worse survival. Screening tools to identify vulnerable patients should be integrated into practice to guide clinical care.