Study protocol for a randomized trial of a supportive care mobile application to improve symptoms, coping, and quality of life in patients with advanced non-small cell lung cancer.

Patients with advanced non-small cell lung cancer (NSCLC) often experience burdensome symptoms, emotional distress, and poor quality of life (QOL). While national guidelines recommend early palliative care to address these supportive care needs, most patients with advanced NSCLC lack access to such comprehensive care. Our aim in the current study is to test a novel model of palliative care delivery and use of innovative technology to evaluate the feasibility, acceptability, and preliminary efficacy of a supportive care mobile application (app) for improving symptom management and adaptive coping in patients with advanced NSCLC. We will enroll 120 patients with unresectable Stage III or IV NSCLC diagnosed within the past 12 weeks receiving care with palliative intent at a major academic comprehensive cancer center and its community affiliates. The study will take place in two phases, the first of which will be dedicated to adapting an evidence-based, early palliative care treatment guide and prior supportive care mobile app intervention to address the specific symptom management and coping needs of patients with advanced NSCLC. The second phase of the study will be a two-group, randomized controlled trial. Study patients will complete baseline self-report measures of symptoms, mood, coping skills, and QOL, after which they will be randomized to receive either the mobile app intervention combined with usual oncology care or usual oncology care alone. Intervention patients will use a tablet computer to self-administer the mobile app, which consists of six modules that teach evidence-based skills for managing burdensome symptoms and coping effectively with advanced cancer and its treatment. At 12 weeks follow up, patients in both groups will repeat the same self-report measures. We will use descriptive statistics to determine feasibility metrics of enrollment and retention rates. For secondary self-report measures, we will use linear regression controlling for baseline values. The results of the present study will contribute to a growing body of evidence regarding the supportive care needs of patients with advanced cancer and will have implications for how best to use innovative technology to widely disseminate comprehensive supportive care services to all patients who may benefit. Clinical Trial Registration: [www.ClinicalTrials.gov], identifier[NCT04629300].

An acceptance and commitment therapy-based intervention for opioid use disorder risk in individuals with cancer: A treatment development study.

This paper describes the iterative development of an evidence-based behavioral intervention for individuals with cancer at risk for opioid use disorder, using the National Institutes of Health Stage Model for Behavioral Intervention Development. Adult patients with cancer from an outpatient palliative care clinic at an academic cancer center, with moderate to high risk of opioid misuse, were enrolled in a treatment development study that aimed to increase psychological flexibility. In this intervention, psychological flexibility is the posited mechanism of change for reduction of opioid use disorder risk. Patients completed baseline (pre-intervention) assessments, a six-session behavioral intervention based in Acceptance and Commitment Therapy, post-intervention assessments, and a semi-structured exit interview. Ten patients with moderate to high risk of opioid misuse completed the intervention. Patients rated the intervention as highly acceptable and were generally highly satisfied. Patients reported finding the coping skills helpful (e.g., mindfulness, cognitive defusion) and reported a preference for more sessions. These treatment development efforts have implications for the development and design of acceptance- and mindfulness-based, targeted interventions for individuals with cancer, receiving palliative care and at risk for opioid use disorder. Specifically, this six-session behavioral intervention to increase psychological flexibility was acceptable to patients and ready to be studied in a pilot RCT.

Experience and supportive care needs of metastatic lung cancer survivors living with uncertainty: a brief qualitative report.

PURPOSE: Molecularly targeted therapies have revolutionized non-small cell lung cancer (NSCLC) treatment. Many patients with metastatic NSCLC receiving targeted therapy may live several years with incurable cancer. We sought to describe how these metastatic cancer survivors and their caregivers experience uncertainty about the future and identify their unmet supportive care needs. METHODS: We conducted semi-structured interviews with patients with metastatic NSCLC receiving targeted therapy (n = 39) and their caregivers (n = 16). We used a framework approach to code and analyze the qualitative data. RESULTS: Metastatic lung cancer survivors described awareness of their mortality and the possibility that their cancer could progress at any time. Though some found ways to cope, many felt inadequately supported to manage their distress, especially since they were "doing fine medically." Survivors struggled with decisions about working and managing their finances given their uncertain life expectancy and sought trustworthy lung cancer information in plain language. They wished to compare experiences with other patients with their molecular subtype of NSCLC. Participants desired comprehensive cancer care that includes psychosocial support, preparation for the future, and ways to promote their own health, such as through lifestyle changes. CONCLUSIONS: Patients with metastatic NSCLC receiving targeted therapy and their caregivers experience distress related to living with uncertainty and desire more coping support, connection with peers, information, and healthy lifestyle guidance. IMPLICATIONS FOR CANCER SURVIVORS: Patients living with treatable yet incurable cancer and their caregivers are a growing population of cancer survivors. Recognition of their unmet needs may inform the development of tailored support services to help them live well with cancer.

An Integrative Framework of Appraisal and Adaptation in Serious Medical Illness.

Multiple randomized clinical trials have demonstrated that palliative care improves the quality of life of individuals with serious medical illness. Research also suggests that in patients with advanced cancer, palliative care's focus on symptom management, coping with illness, goals of care, and treatment decisions may be associated with improved patient quality of life in part by increasing patients' use of active (vs. passive) and approach-oriented (vs. avoidant) coping strategies. However, without a framework outlining the process that individuals with serious medical illness and their loved ones undergo, it is challenging to discern exactly where, how, and why palliative care may affect the serious medical illness experience. To address this gap, we propose a clinically applicable framework, derived from existing theory and research in the social and behavioral sciences. This framework, called the Integrative Framework of Appraisal and Adaptation in Serious Medical Illness, describes how patients and their loved ones cognitively and emotionally process the various events that may occur as they navigate serious medical illness and the end of life. The framework also describes how individuals and their loved ones use that event processing to determine next steps, while considering the impact of their surrounding external environment, their individual social roles, and their connections on this decision making. The framework presented in this article is intended to improve our ability to understand and care for individuals with serious medical illness and their loved ones, while stimulating further discussion and research to test and refine these ideas.

Communication Differences between Oncologists and Palliative Care Clinicians: A Qualitative Analysis of Early, Integrated Palliative Care in Patients with Advanced Cancer.

BACKGROUND: Growing evidence demonstrates the benefits of early, integrated palliative care (PC) for patients with advanced cancer and their caregivers. Yet, data are lacking on the communication patterns within this model of care. OBJECTIVE: The goals of this study were to describe the content of patient-clinician discussions among patients receiving PC and to compare differences in discussion content between oncologists and PC clinicians. DESIGN: We conducted a qualitative observational analysis. SETTING/SUBJECTS: We included patients with incurable lung and esophageal cancer enrolled in a randomized trial of early, integrated PC versus usual oncology care. We analyzed 68 audio-recorded clinic visits (34 oncologist visits; 34 PC clinician visits) immediately after patients' (N = 19) first and second cancer progressions. We examined themes of clinician communication, comparing the content and frequency of discussions between oncologists and PC clinicians. RESULTS: Although both oncology and PC clinicians discussed symptom management, medical understanding, and treatment decision making with patients at nearly all postprogression visits, PC clinicians tended to assess patient understanding of the treatment process and prognosis more often than oncologists. PC clinicians addressed patient coping, caregiver experiences and needs, and advance care planning more frequently than oncologists. CONCLUSION: PC clinicians play a distinct, complementary role to oncologists in providing care for patients with advanced cancer and their caregivers. PC clinicians tend to assess and elaborate on patient understanding of prognosis and treatment and emphasize effective coping, caregiver needs, and advance care planning. These results illuminate the communication elements by which early, integrated PC may improve patient and caregiver outcomes.

Defining the Elements of Early Palliative Care That Are Associated With Patient-Reported Outcomes and the Delivery of End-of-Life Care.

Purpose We describe the key elements of early palliative care (PC) across the illness trajectory and examine whether visit content was associated with patient-reported outcomes and end-of-life care. Methods We performed a secondary analysis of patients with newly diagnosed advanced lung or noncolorectal GI cancer (N = 171) who were randomly assigned to receive early PC. Participants attended at least monthly visits with board-certified PC physicians and advanced practice nurses at Massachusetts General Hospital. PC clinicians completed surveys documenting visit content after each encounter. Patients reported quality of life (Functional Assessment of Cancer Therapy-General) and mood (Hospital Anxiety and Depression Scale and Patient Health Questionnaire-9) at baseline and 24 weeks. End-of-life care data were abstracted from the electronic health record. We summarized visit content over time and used linear and logistic regression to identify whether the proportion of visits addressing a content area was associated with patient-reported outcomes and end-of-life care. Results We analyzed data from 2,921 PC visits, most of which addressed coping (64.2%) and symptom management (74.5%). By 24 weeks, patients who had a higher proportion of visits that addressed coping experienced improved quality of life ( P = .02) and depression symptoms (Depression subscale of the Hospital Anxiety and Depression Scale, P = .002; Patient Health Questionnaire-9, P = .004). Patients who had a higher proportion of visits address treatment decisions were less likely to initiate chemotherapy ( P = .02) or be hospitalized ( P = .005) in the 60 days before death. Patients who had a higher proportion of visits addressing advance care planning were more likely to use hospice ( P = .03). Conclusion PC clinicians' focus on coping, treatment decisions, and advance care planning is associated with improved patient outcomes. These data define the key elements of early PC to enable dissemination of the integrated care model.

Clinician roles in early integrated palliative care for patients with advanced cancer: a qualitative study.

BACKGROUND: Early palliative care provides better quality of life, increased prognostic awareness, and even improved survival for patients with advanced cancer but how the integrated care model achieves these outcomes has not been completely explained. METHODS: To better understand the clinical approach to early outpatient care from the clinicians' perspective, we conducted focus groups with the palliative care clinicians who had participated in a randomized trial of early palliative care for metastatic lung cancer. RESULTS: Clinicians described their role in providing early palliative care as having three distinct roles in the outpatient setting: (1) managing symptoms to improve functional status and as a bridge to other issues; (2) engaging patients in emotional work to facilitate coping, accepting, and planning; and (3) interpreting the oncologist for the patient and the patient for the oncologist. CONCLUSIONS: These data lay the foundation for developing training programs for clinicians in early integrated palliative care.

Early integration of palliative care services with standard oncology care for patients with advanced cancer.

Scientific advances in novel cancer therapeutics have led to remarkable changes in oncology practice and longer lives for patients diagnosed with incurable malignancies. However, the myriad options for treatment have established a culture of cancer care that has not been matched with a similar availability of efficacious supportive care interventions aimed at relieving debilitating symptoms due to progressive disease and treatment side effects. Accumulating data show that the introduction of palliative care services at the time of diagnosis of advanced cancer leads to meaningful improvement in the experiences of patients and family caregivers by emphasizing symptom management, quality of life, and treatment planning. In this review article, the rationale and evidence base for this model of early palliative care services integrated into standard oncology care are presented. In addition, the implications and limitations of the existing data to 1) elucidate the mechanisms by which early palliative care benefits patients and families; 2) guide the dissemination and application of this model in outpatient settings; and 3) inform health care policy regarding the delivery of high-quality, cost-effective, and comprehensive cancer care are discussed.

The cultivation of prognostic awareness through the provision of early palliative care in the ambulatory setting: a communication guide.

Early, integrated palliative care delivered in the ambulatory setting has been associated with improved quality of life, lower rates of depression, and even prolonged survival. We outline an expert practice that provides a step-wise approach to cultivating prognostic awareness in patients cared for by a palliative care clinician early in the course of the patient's disease. This approach can be used by both novice and more experienced palliative care clinicians.