Expressive writing to address distress in hospitalized adults with acute myeloid leukemia: a pilot randomized clinical trial.

PURPOSE: Patients with acute myeloid leukemia (AML) experience significant distress. Expressive writing is an intervention designed to improve well-being by encouraging expression of emotions related to traumatic experiences. Expressive writing has been shown to be generally feasible and effective at improving the cancer experience but has not been examined in patients with recently diagnosed hematologic malignancies. We examined the feasibility of an expressive writing intervention for hospitalized patients with AML receiving induction chemotherapy. METHODS: Fifteen hospitalized AML patients were randomized to complete expressive writing or neutral prompts. Feasibility was defined as 80% of enrolled subjects completing the study. Participants completed validated questionnaires measuring depression, anxiety, resilience, rumination, and quality of life at baseline, completion of the second and fourth writing exercises, and 3 months after enrollment. Participants also completed post-writing surveys following the writing exercise to reflect on the experience. FINDINGS: We enrolled 15 participants and 8 of 15 subjects (53%) completed the study. Due to low enrollment, we examined the pre-to-post intervention changes, rather than comparing results across intervention arms. Pre-to-post intervention changes in the expected direction were seen at the second assessment for depression and resilience, at the fourth assessment for rumination, emotional well-being, and social well-being, and at the 3-month follow-up for anxiety and emotional well-being. Similar changes in patient-reported outcomes were also seen in the control condition. Participants who completed the intervention reported the experience was meaningful and were able to express their deepest thoughts and feelings, more so than participants in the control arm. CONCLUSION: In our work, the expressive writing intervention was not found to be feasible. The trial was interrupted by the COVID-19 pandemic which likely impacted the feasibility. Future studies should aim to identify ways to make the intervention more accessible, such as developing an electronic application for expressive writing.

In their own words: a qualitative study of coping mechanisms employed by patients with acute myeloid leukemia.

PURPOSE: Positive coping mediates improved outcomes from integrated palliative care in acute myeloid leukemia (AML). We qualitatively explored patients' coping mechanisms to better understand this relationship. METHODS: We enrolled patients with high-risk AML admitted to Duke Hospital's inpatient hematologic malignancy service for intensive chemotherapy. This study is a secondary analysis of previously collected longitudinal qualitative data, with interviews conducted between February 2014 and August 2015. Interviews were coded in NVivo to identify examples of approach-oriented and avoidant coping. RESULTS: Patients demonstrated approach-oriented coping in many forms including acceptance, positive reframing, active coping, religious coping, and social coping. Acceptance included accepting their prognosis, the uncertainty of AML, and lifestyle changes due to the disease. Patients exhibited positive reframing by speculating about how their situation could be worse, deriving meaning from their experience, and expressing newfound appreciation for activities previously taken for granted. Social coping involved patients receiving support from their community or care team; however, some expressed guilt for being a "burden" on family. Avoidant coping included denial, behavioral disengagement, and self-blame. Some denied their prognosis, but denial was more commonly demonstrated via patients cognitively distancing themselves from their disease. Much of the behavioral disengagement described by patients was attributed to their symptoms (i.e., lethargy) which prevented patients from maintaining relationships or participating in activities previously enjoyed. CONCLUSION: These results demonstrate the diverse and nuanced applications of coping mechanisms amid a recent AML diagnosis. Future research should examine coping in the context of novel low-intensity AML therapies.

Patient-Reported Distress and Clinical Outcomes with Immuno-Oncology Agents in Metastatic Non-Small Cell Lung Cancer (mNSCLC): A Real-World Retrospective Cohort Study.

OBJECTIVES: There are limited real-world data about patient-reported outcomes with immunotherapies (IO) in metastatic non-small cell lung cancer (mNSCLC). We describe patient-reported distress and clinical outcomes with IO-based treatments or cytotoxic chemotherapies (Chemo). METHODS: We conducted a single-institution retrospective chart review of adults with mNSCLC treated at Duke from 03/2015 to 06/2020. At each visit, patients self-reported their distress level and sources of distress using the NCCN Distress Thermometer (DT) and its 39-item Problem List. We abstracted demographic, clinical, distress, and investigator assessed-clinical response data, then analyzed these using descriptive statistics and generalized estimating equations. RESULTS: Data from 152 patients were analyzed in four groups: Chemo alone, IO + Chemo, single agent IO, dual agent IO. Distress was worse before treatment start in all groups, and the odds of actionable distress (DT score > 4) decreased by 10 % per month. The most frequent sources of distress were physical symptoms (e.g., fatigue, pain), which remained high longitudinally. Patients receiving IO had higher clinical response rates and a lower rate of unplanned healthcare encounters compared to patients treated with Chemo alone. Only one-third of all patients were seen by palliative care. CONCLUSIONS: This single-center, real-world evidence study demonstrates that patients with mNSCLC experience significant distress prior to starting first-line treatment. IO treatment was associated with higher clinical benefit rates and lower healthcare utilization compared to chemotherapy. Symptom distress persists over time, highlighting potential unmet palliative and supportive care needs in mNSCLC care in the IO treatment era.

A single-site pilot feasibility randomized trial of a supportive care mobile application intervention for patients with advanced cancer and caregivers.

PURPOSE: Mobile health interventions can improve patient care. We developed the Digital Supportive Care Awareness and Navigation (D-SCAN) application (app) to facilitate symptom monitoring and use/awareness of cancer supportive care resources. This study tested feasibility, usability/satisfaction, and preliminary efficacy of D-SCAN. METHODS: We randomized 50 patients with advanced cancer to receive the D-SCAN intervention or usual care; 10 caregivers also received D-SCAN. The primary feasibility outcome was determined by weekly symptom survey completion and end of study procedures. We assessed secondary outcomes including usability/satisfaction, awareness/use of supportive care resources, patient activation, and quality of life via various questionnaires including the Net Promoter Score (NPS), Patient Activation Measure (PAM-13), Functional Assessment of Cancer Therapy-General (FACT-G), and Caregiver Oncology Quality of Life (CarGOQOL) questionnaire. RESULTS: Seventy-six percent of intervention patients met feasibility criteria, exceeding our pre-determined threshold of 75%. Usability/satisfaction by NPS was high, at 14.3% and 12.5% for patients and caregivers, respectively. Intervention patient and caregiver resource awareness increased by a mean of 3.7 (p = 0.27) and 4.1 items, respectively. Supportive care resource utilization increased by a mean of 0.8 items for intervention patients (p = 0.70) and 0.6 for caregivers. PAM-13 increased by a mean of 1.6 for intervention patients (p = 0.65). FACT-G increased by a mean of 1.1 for intervention patients (p = 0.91), and CarGOQoL increased by a mean of 2.2 (p = 0.41). CONCLUSION: D-SCAN is a feasible, usable, and satisfactory intervention for augmenting patient and caregiver supportive care. Further testing is necessary to formally assess D-SCAN's efficacy and impact on patients and caregivers. CLINICAL TRIAL REGISTRATION NUMBER: NCT03628794. Registered on August 14th, 2018.

The relationship between emotional well-being and understanding of prognosis in patients with acute myeloid leukemia (AML).

PURPOSE: Adults with acute myeloid leukemia (AML) face considerable distress and often have a poor prognosis. However, little is known about these patients' perceptions of prognosis and how this relates to emotional well-being (EWB). METHODS: We conducted a prospective, observational study of 50 adult patients with AML initiating chemotherapy, and surveyed them longitudinally for 6 months about their prognosis, treatment goals, quality of life, and EWB (by FACT-G). We derived a prognostic estimate for each patient based on data from published trials summarized in National Comprehensive Care Network Guidelines. We used descriptive statistics and longitudinal modeling to test the hypothesis that more accurate prognostic awareness is associated with worse EWB. RESULTS: Most patients (n = 43; 86%) had an objectively poor prognosis attributable to relapsed disease, complex karyotype, or FLT3 mutation. Yet, 74% of patients reported expecting a 50% or greater chance of cure. Patients with a poor prognosis more often had discordant prognostic estimates, compared to those with favorable risk AML (OR = 7.25, 95% CI 1.21, 43.37). Patient-reported prognostic estimates did not vary significantly over time. At baseline, patients who better understood their prognosis had worse EWB and overall quality-of-life scores (EWB 12 vs. 19.5; p = 0.01; FACT-G 65 vs. 75.5; p = 0.01). CONCLUSION: Patients with AML overestimate their prognosis, and awareness of a poor prognosis is associated with worse emotional well-being. Efforts are needed to improve patients' understanding of their prognosis, and to provide more psychosocial support and attention to well-being as part of high-quality leukemia care.

A novel decision aid for acute myeloid leukemia: a feasibility and preliminary efficacy trial.

PURPOSE: Acute myeloid leukemia (AML) is a hematologic malignancy characterized by a poor prognosis but also a paradoxical possibility of cure. This renders decision-making complex and imminent. Unfortunately, many patients with AML misestimate their prognosis and treatment risk. While decision aids can improve illness understanding and reduce decisional conflict, there are no validated decision aids for AML. We developed and tested a novel AML decision aid (NCT03442452). METHODS: Patients (n = 20) were recruited at Duke University from May 2018 to February 2019. Participants completed assessments of AML knowledge and decisional conflict, before and after using the electronic decision aid. The primary endpoint was feasibility (endpoint met if > 80% of study participants completed all study components). Secondary analyses of efficacy were conducted using paired t tests for dependent pre-/post-samples. RESULTS: The primary endpoint of feasibility was met (100% of participants completed all study components). Secondary analyses showed improved knowledge and reduced decisional conflict after using the decision aid. Knowledge scores improved from a mean of 11.8 (out of 18) correct items at baseline to 15.1 correct items after using the decision aid (mean difference 3.35; p < 0.0001). Decisional conflict scores reduced significantly from baseline to post-test as well (mean difference - 6.5; p = 0.02). CONCLUSION: These findings suggest that our AML decision aid is a useful tool to improve the patient experience and promote shared decision-making in AML. A randomized efficacy trial is planned.

An analysis of missing items in real-world electronic patient reported outcomes data: implications for clinical care.

PURPOSE: Utilization of electronic patient-reported outcomes (ePROs) in the clinic can improve quality of life and prolong survival in cancer care. However, there remain unanswered questions regarding trends in missing data and the potential effect on real-time patient care. METHODS: This study utilized a prospectively collected dataset of ePROs from oncology clinics that administered the Patient Care Monitor 2.0 (PCM), a validated symptoms survey assessing 78 items for men, and 86 for women. We tabulated the frequency of missing items, by item and domain (emotional, functional and physical symptom-related), and examined these by age, gender, education, race and marital status. RESULTS: Within 20,986 encounters, there were responses to at least 1 PCM item from 6933 unique patients. The highest frequency of missing answers occurred for: "attend a paid job" (10.7%), "reduced sexual enjoyment" (3.8%), and "run" (3.7%). By domain, 12.3% of functional, 8.4% of physical symptom-related, and 1.6% of emotional constructs contained at least one missing item. For functional and physical symptom-related items, missingness was most common in patients >60 years old. CONCLUSION: The frequency of missingness was highest for functional items, like attending a paid job, suggesting that some respondents (e.g., retirees without a paid job) skipped questions that were less applicable to them. More universal issues for cancer patients, such as emotional well-being, had much lower frequencies of missingness. This suggests differential item completion that warrants further study to understand the inherent drivers. Identifying causes of missingness could improve the clinical utility of ePROs and highlight opportunities to personalize care.

Pruritus in patients with solid tumors: an overlooked supportive care need.

PURPOSE: Pruritus is a common symptom in cutaneous malignancies, but its impact on patients with solid tumors is unclear. We explored the impact and management of pruritus in patients with solid tumors, using patient-reported outcomes (PRO) data from a real-world registry. METHODS: From 2006 to 2011, patients seen in the Duke Cancer Institute reported their symptoms via the Patient Care Monitor v2.0, a validated PRO tool that includes a 0-10-point question about pruritus severity. From > 25,000 encounters, 203 patients reported severe pruritus (> 6/10) on at least one visit and 506 total visits were abstracted where patients reported either moderate or severe pruritus (> 3/10). From this cohort, we abstracted demographics, diagnosis, stage, cancer therapy, anti-pruritic therapy, and clinicians' responses. RESULTS: Mean age was 59.8 (SD 13.3), 134 (66%) were female, 125 (62%) were Caucasian, and 65 (32%) were African American. Breast cancer was the most common tumor (36.5%), followed by lung cancer (23.2%). Mean pruritus severity score was 6.8 (SD 1.8) for patients on chemotherapy, 6.9 (SD 1.8) for patients on targeted therapy alone or in combination, and 7.1(SD 1.8) for patients off treatment. Overall, 67% of patients reported at least two episodes of moderate-severe pruritus (mean # of visits 4.2 (SD 2.7)). Despite frequent report of severe and persistent pruritus, this was mentioned in just 28% of clinician notes and an intervention was recommended/prescribed in only 7% of visits. CONCLUSIONS: Pruritus is an under-addressed symptom in patients with solid tumors. Additional research is needed to understand the burden of pruritus in affected populations.

Patient-reported distress in Hodgkin lymphoma across the survivorship continuum.

PURPOSE: Hodgkin lymphoma (HL) survivors face long-term, elevated risk of treatment-related sequelae, including psychosocial distress associated with poor health outcomes. The magnitude and sources of distress are not well described in the routine care of HL outside of clinical trials. METHODS: We conducted a retrospective cohort study of patients visiting a tertiary-care center for treatment or long-term follow-up of HL. Patient-reported distress was documented using the National Comprehensive Cancer Network Distress Thermometer (DT) and Problem List. Three survivor groups were compared using descriptive methods: on treatment, surviving < 5 years, and surviving ≥ 5 years since diagnosis. RESULTS: A total of 1524 DT were abstracted for 304 patients (106 on treatment, 77 surviving < 5 years, and 121 surviving ≥ 5 years). Distress was low overall (median DT = 1, inter-quartile range 0-4) and was similar across survivor groups. However, actionable distress (score ≥ 4) was reported at 29.5% of clinical encounters. Patients on treatment more frequently reported actionable distress (32.5% of visits) compared with patients surviving < 5 years (20.4%) and ≥ 5 years (28.7%) (P = 0.065). Distress was associated primarily with physical and emotional problems, especially fatigue, worry, and sleep. We did not observe any associations between distress and clinical prognostic factors. CONCLUSIONS: Distress burden is low in HL, but survivorship is marked by periods of actionable distress, largely related to physical symptoms and emotional issues. This burden may be higher when on treatment and is unrelated to disease-related prognostic factors. Survivorship research typically focuses on the post-therapy period, but our results support testing the efficacy of interventions to address distress in HL during active treatment as well.

The impact of remission status on patients' experiences with acute myeloid leukemia (AML): an exploratory analysis of longitudinal patient-reported outcomes data.

PURPOSE: Shared decision-making in acute myeloid leukemia (AML) requires understanding patients' longitudinal experiences of illness, but little is known about the impact of remission status on patient-reported outcomes (PROs). We aimed to explore the association between remission status and PROs 6-12 months following induction chemotherapy. METHODS: Forty-two patients completed three validated instruments characterizing symptom burden (Patient Care Monitor v2.0), distress (NCCN Distress Thermometer), and QOL (FACT-Leu), as part of a longitudinal observational study. We used regression models to explore the relationship between remission status and PROs, and explore differences by initial disease type (de novo versus secondary/relapsed AML). RESULTS: Those with secondary or relapsed AML at study onset had marked impairments in all measures compared to de novo AML patients. After 6 months, their mean distress score was 4.8 (> 4.0 warrants intervention), they reported a mean of 14.1 moderate/severe symptoms and had a mean QOL score of 113.6, compared to 1.0, 1.7, and 155.2, respectively, for those with de novo AML (p < .0001). Similarly, patients in relapse had a mean distress score of 5.3, a mean of 12.8 moderate/severe symptoms, and a mean QOL score of 113.4, compared to 1.8, 5.7, and 143.8, respectively, among those in remission (p < .005). These patterns persisted after adjusting for baseline differences (p < .0001). CONCLUSION: Remission is associated with markedly better patient well-being in AML. Patients with secondary or relapsed AML face more severe symptom burden, distress, and QOL issues after induction. Interventions are needed to improve AML patients' experiences of illness.

Patient experiences of acute myeloid leukemia: A qualitative study about diagnosis, illness understanding, and treatment decision-making.

BACKGROUND: Patients with acute myeloid leukemia (AML) face a unique, difficult situation characterized by sudden changes in health, complex information, and pressure to make quick treatment decisions amid sizeable tradeoffs. Yet, little is known about patients' experiences with AML. We used qualitative methods to learn about their experiences with diagnosis and treatment decision-making to identify areas for improvement. METHODS: We recruited hospitalized patients with AML to participate in semi-structured qualitative interviews about their experiences being diagnosed with AML, receiving information, and making a treatment decision. Interviews were conducted during their hospitalization for induction chemotherapy. We analyzed data by using a constant comparison approach. RESULTS: Thirty-two patients completed an interview. Four main themes emerged: (a) shock and suddenness, (b) difficulty processing information, (c) poor communication, and (d) uncertainty. Patients frequently described their diagnosis as shocking. They also felt that the amount of information was too great and too difficult to process, which negatively impacted their understanding. Patients frequently described a lack of emotional support from clinicians and described uncertainty about their prognosis, the number and nature of available treatments, and what to expect from treatment. CONCLUSIONS: Acute myeloid leukemia poses a sudden, emotionally challenging, information-laden situation, where little time is available to make important decisions. This results in difficulty processing information and is sometimes complicated by a lack of emotive communication from clinicians. Results indicate a need for targeted interventions to improve AML patients' understanding of illness and treatment options and to address their traumatic experiences around diagnosis.

Experience of the National Cancer Institute Community Cancer Centers Program on Community-Based Cancer Clinical Trials Activity.

PURPOSE: A goal of the National Cancer Institute Community Cancer Centers Program (NCCCP) was to improve cancer research capacity in community settings. We examined research capacity development during the pilot phase of the NCCCP within the context of national trends in clinical trial activity with respect to the number and phase of trials, total accrual, and accrual of underserved populations. MATERIALS AND METHODS: We examined self-reported data from NCCCP sites during 2007 to 2010, supplemented with data from the National Cancer Institute Cancer Therapy Evaluation Program. RESULTS: Trial availability and accrual improved more quickly at NCCCP sites compared with national trends. Phase III trial availability increased 8% nationally versus 16% across NCCCP sites, and accrual increased 30% nationally versus 133% across NCCCP sites. Accrual of racial and ethnic minorities rose 82%, from 83 to 151 patients, and accrual of patients age ≥ 65 years rose by 221%, from 200 to 641 patients. Change in trial portfolio and accrual differed by sophistication of the site and by prior experience in conducting clinical trials at the site. CONCLUSION: Despite the short duration, the NCCCP pilot resulted in an increase in the number of open trials as well as patient accrual at a faster rate than that observed nationally. These results, coupled with insights into the relative success of sites with varying sophistication at the outset, provide promise that lessons learned can be applied more broadly to increase research participation.

What bothers lung cancer patients the most? A prospective, longitudinal electronic patient-reported outcomes study in advanced non-small cell lung cancer.

PURPOSE: Patients with advanced non-small cell lung cancer (aNSCLC) face a significant symptom burden. Little is known about the frequency and severity of symptoms over time, so we longitudinally characterized patients' symptoms using the Patient Care Monitor (PCM) version 2.0, an electronic symptom-assessment tool. METHODS: Ninety-seven patients with aNSCLC completed the PCM at up to four clinic visits. We analyzed symptom data by incidence, severity, type (functional vs. nonfunctional), proximity to death, and cancer anorexia-cachexia syndrome status (CACS). RESULTS: Functional concerns predominated, even in the non-CACS group. Average severity among the top 5 symptoms was worse for functional than nonfunctional items (mean difference 0.62, 95% CI 0.22-1.01, P = 0.003). Severe dyspnea and fatigue were the most prevalent nonfunctional symptoms; moderate/severe dyspnea was reported by at least 29% of patients, and fatigue by over 50%. Depression was reported infrequently, with over half of patients at each visit reporting "none"; moderate or severe depression was reported in only 2.5-9.3 and 3.4-6.2% of patients, respectively. The average number of moderate/severe symptoms increased with proximity to death; 84% reported moderate/severe fatigue in the last 3 months of life, compared to 48% at ≥ 12 months from death (P = 0.007). CONCLUSIONS: Patients with aNSCLC face a significant symptom burden, which increases with proximity to death. Symptom type and severity vary by proximity to death, but even patients without overt CACS report significant functional symptoms throughout. We recommend an individualized approach to palliative symptom intervention in advanced lung cancer, based on detailed symptom assessment and tracking.

Validation and real-world assessment of the Functional Assessment of Anorexia-Cachexia Therapy (FAACT) scale in patients with advanced non-small cell lung cancer and the cancer anorexia-cachexia syndrome (CACS).

PURPOSE: Patients with cancer anorexia-cachexia syndrome (CACS) suffer a significant symptom burden, impaired quality of life (QoL), and shorter survival. Measurement of QoL impairments related to CACS is thereby important both in clinical practice and in research. We aimed to further validate the Functional Assessment of Anorexia-Cachexia Therapy (FAACT) scale in an advanced lung cancer population. METHODS: We tested the performance of the FAACT and its anorexia-cachexia subscale (ACS) within a dataset of patients with advanced non-small cell lung cancer (aNSCLC), using standard statistical methods. We then compared the performance of commonly used QoL measures stratified by CACS status and by patient self-report of appetite and weight loss. RESULTS: The FAACT and its ACS demonstrate internal validity consistent with acceptable published ranges for other QoL scales (Cronbach alpha = 0.9 and 0.79, respectively). Correlation coefficients demonstrate moderate correlations in the expected directions between FAACT and ACS and scales that measure related constructs. Comparing patients with and without CACS, the ACS is more sensitive to change than other QoL instruments (mean score 33.1 vs. 37.2, p = 0.011, ES = 0.58). CONCLUSION: In patients with aNSCLC, the FAACT and its ACS performed well compared with other instruments, further supporting their validity and value in clinical research. FAACT and ACS scores covaried with symptoms and other QoL changes that are typical hallmarks of CACS, lending further support to their use as QoL endpoints in clinical trials among patients with CACS.

Correlation between the international consensus definition of the Cancer Anorexia-Cachexia Syndrome (CACS) and patient-centered outcomes in advanced non-small cell lung cancer.

CONTEXT: The cancer anorexia-cachexia syndrome (CACS) is common in patients with advanced solid tumors and is associated with adverse outcomes including poor quality of life (QOL), impaired functioning, and shortened survival. OBJECTIVES: To apply the recently posed weight-based international consensus CACS definition to a population of patients with advanced non-small cell lung cancer (NSCLC) and explore its impact on patient-reported outcomes. METHODS: Ninety-nine patients participated in up to four study visits over a six-month period. Longitudinal assessments included measures of physical function, QOL, and other clinical variables such as weight and survival. RESULTS: Patients meeting the consensus CACS criteria at Visit 1 had a significantly shorter median survival (239.5 vs. 446 days; hazard ratio, 2.06, P < 0.05). Physical function was worse in the CACS group (mean Karnofsky Performance Status score 68 vs. 77, Eastern Cooperative Oncology Group Performance Status score 1.8 vs. 1.3, P < 0.05 for both), as was QOL (Functional Assessment of Cancer Therapy-General [FACT-G] Lung Cancer subscale of 17.2 vs. 19.9, Anorexia/Cachexia subscale of 31.4 vs. 37.9, P < 0.05 for both). Differences in the FACT-G and the Functional Assessment of Chronic Illness Therapy-Fatigue subscale approached but did not reach statistical significance. Longitudinally, all measures of physical function and QOL worsened regardless of CACS status, but the rate of decline was more rapid in the CACS group. CONCLUSION: The weight-based component of the recently proposed international consensus CACS definition is useful in identifying patients with advanced NSCLC who are likely to have significantly inferior survival and who will develop more precipitous declines in physical function and QOL. This definition may be useful for clinical screening purposes and identify patients with high palliative care needs.