Impact of an automated, remote monitoring and coaching intervention in reducing hospice cancer family caregiving burden: A multisite randomized controlled trial.

BACKGROUND: Care for those with life-limiting cancer heavily involves family caregivers who may experience significant physical and emotional burden. The purpose of this study was to test the impact of Symptom Care at Home (SCH), an automated digital family caregiver coaching intervention, during home hospice, when compared to usual hospice care (UC) on the primary outcome of overall caregiver burden. Secondary outcomes included Caregiver Burden at weeks 1 and 8, Mood and Vitality subscales, overall moderate-to-severe caregiving symptoms, and sixth month spouse/partner bereavement outcomes. METHODS: Using a randomized, multisite, nonblinded controlled trial, 332 cancer family caregivers were enrolled and analyzed (159 SCH vs. 173 UC). Caregivers were primarily White (92%), female (69%), and spouse caregivers (53%). Caregivers provided daily reports on severity levels (0-10 scale) for their anxiety, depressed mood, fatigue, disturbed sleep, and caregiving interference with normal activities. These scores combined constituted the Caregiver Burden primary outcome. Based on reported symptoms, SCH caregivers received automated, tailored coaching about improving their well-being. Reports of moderate-to-severe caregiving symptoms also triggered hospice nurse notification. Secondary outcomes of Mood and Vitality were subcomponents of the Caregiver Burden score. A combined bereavement adjustment tool captured sixth month bereavement. RESULTS: The SCH intervention reduced overall Caregiver Burden compared to UC (p < .001), with a 38% reduction at 8 weeks and a medium-to-large effect size (d = .61). SCH caregivers experienced less (p < .001) disruption in both Mood and Vitality. There were higher levels of moderate-to-severe caregiving symptoms overtime in UC (OR, 2.722). All SCH caregivers benefited regardless of caregiver: sex, caregiver relationship, age, patient diagnosis and family income. SCH spouse/partner caregivers achieved better sixth month bereavement adjustment than UC (p < .007). CONCLUSIONS: The SCH intervention significantly decreased caregiving burden over UC and supports the maintenance of family caregiver mood and vitality throughout caregiving with extended benefit into bereavement.

Inflammatory Breast Cancer: Understanding the Patient Experience.

BACKGROUND: Inflammatory breast cancer (IBC) is an aggressive, locally advanced cancer with a 5-year survival rate of approximately 40%. Although patients with IBC likely experience significant and variable symptom burden from diagnosis through survivorship, the description of the symptom burden in this population is limited. OBJECTIVES: The purpose of this study was to describe the experience of patients with IBC and define the content domain for a patient-reported outcome measure of IBC symptom burden. METHODS: Twenty patients with IBC described their experience in single qualitative interviews. Content analysis was used to define the symptom burden content domain. Relevance ratings by a panel of experts reduced the number of items for a preliminary patient-reported outcome symptom burden measure. RESULTS: The mean (SD) participant age was 52.8 (12.0) years; 50.0% had distant metastatic disease, and 85.0% were currently receiving treatment. Content analysis revealed 45 symptoms, with 20 symptoms reported by greater than or equal to 20% of participants. All participants described localized disease-related symptoms. Treatment-related symptoms varied among participants based on the modalities received. CONCLUSION: Patients with IBC experience symptom burden that is distinct from the symptom burden experienced by patients with non-IBC. IMPLICATIONS FOR PRACTICE: Differentiating the disease-related symptoms of IBC may assist clinicians in making timely and accurate diagnoses for IBC. A disease- and treatment-specific measure of the symptom burden of IBC should be incorporated in clinical practice to allow for regular assessment and evaluation of symptom burden and implementation of evidence-based interventions for symptom management.

Measuring symptom burden in patients with cancer during a pandemic: the MD Anderson symptom inventory for COVID-19 (MDASI-COVID).

BACKGROUND: Symptom expression in SARS-CoV-2 infection (COVID-19) may affect patients already symptomatic with cancer. Patient-reported outcomes (PROs) can describe symptom burden during the acute and postacute stages of COVID-19 and support risk stratification for levels of care. At the start of the COVID-19 pandemic, our purpose was to rapidly develop, launch through an electronic patient portal, and provide initial validation for a PRO measure of COVID-19 symptom burden in patients with cancer. METHODS: We conducted a CDC/WHO web-based scan for COVID-19 symptoms and a relevance review of symptoms by an expert panel of clinicians treating cancer patients with COVID-19 to create a provisional MD Anderson Symptom Inventory for COVID-19 (MDASI-COVID). English-speaking adults with cancer who tested positive for COVID-19 participated in the psychometric testing phase. Patients completed longitudinal assessments of the MDASI-COVID and the EuroQOL 5 Dimensions 5 Levels (EQ-5D-5L) utility index and visual analog scale, which were presented through an electronic health record patient portal. To test the validity of the MDASI-COVID to distinguish between known groups of patients, we hypothesized that patients hospitalized, including having a hospitalization extended, for COVID-19 versus those not hospitalized would experience higher symptom burden. Correlation of mean symptom severity and interference scores with relevant EQ-5D-5L scores tested concurrent validity. The reliability of the MDASI-COVID was evaluated by calculating Cronbach alpha coefficients and test-retest reliability was evaluated by calculating Pearson correlation coefficients between the initial assessment and a second assessment no more than 14 days later. RESULTS: The web-based scan found 31 COVID-19-related symptoms; rankings of a 14-clinician expert panel reduced this list to 11 COVID-specific items to be added to the core MDASI. Time from literature scan start in March 2020 to instrument launch in May 2020 was 2 months. Psychometric analysis established the MDASI-COVID's reliability, known-group validity, and concurrent validity. CONCLUSIONS: We were able to rapidly develop and electronically launch a PRO measure of COVID-19 symptom burden in patients with cancer. Additional research is needed to confirm the content domain and predictive validity of the MDASI-COVID and define the symptom burden trajectory of COVID-19.

Technology-Assisted mHealth Caregiver Support to Manage Cancer Patient Symptoms: A Randomized Controlled Trial.

CONTEXT: Caregivers managing symptoms of family members with cancer during home hospice care, often feel ill-prepared and need patient care coaching. OBJECTIVES: This study tested the efficacy of an automated mHealth platform that included caregiver coaching on patient symptom care and nurse notifications of poorly controlled symptoms. The primary outcome was caregiver perception of patients' overall symptom severity throughout hospice care and at weeks one, two, four, and eight. Secondary outcomes compared individual symptom severity. METHODS: Caregivers (n = 298) were randomly assigned to the Symptom Care at Home (SCH) intervention (n = 144) or usual hospice care (UC) (n = 154). All caregivers placed daily calls to the automated system that assessed the presence and severity of 11 end-of-life patient physical and psychosocial symptoms. SCH caregivers received automated coaching on symptom care based on reported patient symptoms and their severity. Moderate-to-severe symptoms were also relayed to the hospice nurse. RESULTS: The SCH intervention produced a mean overall symptom reduction benefit, over UC, of 4.89 severity points (95% CI 2.86-6.92) (P < 0.001), with a moderate effect size (d = 0.55). The SCH benefit also occurred at each timepoint (P < 0.001- 0.020). There was a 38% reduction in days reporting moderate-to-severe patient symptoms compared to UC (P < 0.001) with 10/11 symptoms significantly reduced in SCH compared to UC. CONCLUSION: Automated mHealth symptom reporting by caregivers, paired with tailored caregiver coaching on symptom management and nurse notifications, reduces cancer patients' physical and psychosocial symptoms during home hospice, providing a novel and efficient approach to improving end-of-life care.

The Bereavement Experience for Partners of Patients With Central Nervous System Tumors.

PURPOSE: To describe the experience of caregivers who have lost a partner to a central nervous system (CNS) tumor. PARTICIPANTS & SETTING: 8 bereaved partners of patients with CNS tumors enrolled in a dyadic, behavioral randomized controlled trial at a comprehensive cancer center in the southern United States. METHODOLOGIC APPROACH: Participants took part in a semistructured qualitative interview to describe the experience of their partner's death. Descriptive exploratory analysis was used to identify themes emerging from the interviews. FINDINGS: Themes identified from bereaved participants' experiences were related to caring for their partner, separating from their partner on patient death, and continuing without their partner following patient death. IMPLICATIONS FOR NURSING: Bereaved partners of patients with CNS tumors described how difficult it was to experience the patient's health decline and feeling unprepared for the patient's death, regardless of advance notice. Interventions targeting caregiver distress to improve their experience prior to and following the patient's death are needed.

Identification of Breast Cancer Survivors With High Symptom Burden.

BACKGROUND: While women diagnosed with breast cancer have increased survival when compared with other cancers, survivorship may include residual symptom burden from treatment and continuing endocrine therapies. OBJECTIVE: The objective of this study was to identify subgroups of breast cancer survivors experiencing similar symptom severity. METHODS: Participants were 498 women with breast cancer, not on active treatment. Symptom severity was self-reported using the MD Anderson Symptom Inventory. Target symptoms were included in a latent profile analysis. Factors related to subgroup membership and differences in quality of life (QOL) and functioning were explored using logistic regression. RESULTS: Mean age was 60.11 (SD, 11.32) years, 86.1% were white, and 79.1% were receiving endocrine therapy. Target symptoms included fatigue (reported at ≥5 by 22.8% of women), sleep disturbance (24.8%), and trouble remembering (17.2%). Two subgroups were identified: low symptom severity (77.0% of women) and high (23.0%). Older women (odds ratio [OR], 0.971; 95% confidence interval [CI], 0.952-0.989) and employed women (OR, 0.621; 95% CI, 0404-0.956) were less likely to be in the high subgroup; women with poorer performance status (OR, 1.653; 95% CI, 1.188-2.299) were more likely to be in the high subgroup. Women in the high subgroup reported lower QOL (P = .000) and greater interference with functioning (P = .000). CONCLUSIONS: Two subgroups of women with distinct symptom severity were identified. IMPLICATIONS FOR PRACTICE: Identification of women at risk for high symptoms during survivorship may allow clinicians to intensify their approach to symptom management, thereby mitigating poor outcomes and impairments in QOL.

Symptom-related patient-provider communication among women with breast cancer receiving chemotherapy.

PURPOSE: The purpose of this study was to determine the extent to which women being treated for breast cancer discussed their symptoms during the week prior to a clinic visit. METHOD: Women reported the severity of 11 symptoms (0-10 scale) daily using an automated patient-reported outcomes system. Clinic visits were audio recorded, and symptom discussions were coded. Moderate to severe symptoms reported in the week prior to the visit were compared to the symptoms discussed at the visit. RESULTS: Twenty-six clinic visits of 10 women (mean age, 51.6 years; half had advanced disease) were recorded. In the week prior to their visits, participants provided 183 reports of moderate to severe symptoms. Reported symptoms were discussed at 49.5% of visits, with 36% of discussions initiated by patients. These discussions were more likely to include assessment and normalizing and were less focused on intensifying symptom management. Symptom discussions were more likely with younger women and the time spent discussing symptoms decreased over subsequent visits for all women. CONCLUSIONS: Women who are symptomatic during treatment are not systematically queried about their symptoms, nor are women effectively reporting their symptoms. Attention should be directed at eliciting symptoms from older women; symptoms should be discussed throughout the duration of chemotherapy.

The Unique Symptom Burden of Patients Receiving CAR T-Cell Therapy.

OBJECTIVES: There is little research on the patient experience of symptom burden from CAR T-cell therapy, and no validated measure specific to the symptoms of CAR T-cell therapy currently exists. The purpose of this study was to identify symptoms experienced and to determine the content domain for a patient-reported outcome (PRO) measuring symptom burden for patients who had received standard of care CAR T-cell therapy for advanced B-cell lymphoid malignancies. DATA SOURCES: Semi-structured qualitative interviews were conducted with a sample of 21 patients who had received CAR T-cell therapy. Content analysis was used to define the symptom burden content domain. CONCLUSION: Sixty-two percent of patients were interviewed within 3 months of therapy; 81.0% experienced cytokine release syndrome and 28.6% experienced neurotoxicity. Content analysis found 31 symptoms related to disease and treatment. The most common disease-related symptom identified by patients was pain (43%). The most common symptoms identified by patients as related to CAR T-cell therapy included fatigue (tiredness) (62%), lack of appetite (29%), headache (29%), chills or feeling cold (24%), and feeling confused (24%). The qualitative analysis also confirmed that symptoms interfere with daily activities, work, walking, relationships with others, mood, and enjoyment of life. IMPLICATIONS FOR NURSING PRACTICE: Patients who receive standard CAR T-cell therapy experience numerous symptoms related to disease and CAR T-cell therapy, including symptoms related to the T-cell infusion. Symptoms may result in interference with daily activities, relationships, treatment adherence, and mood. Oncology nurses should be aware of and assess symptom related to CAR T-cell therapy.

Videoconferenced Yoga Interventions for Cancer Patients and their Caregivers during the COVID-19 Pandemic: A Report from a Clinician's Perspective.

BACKGROUND: The acceptability of videoconferencing delivery of yoga interventions in the advanced cancer setting is relatively unexplored. The current report summarizes the challenges and solutions of the transition from an in-person (ie, face-to-face) to a videoconference intervention delivery approach in response to the Coronavirus Disease pandemic. METHOD: Participants included patient-family caregiver dyads who were enrolled in ongoing yoga trials and 2 certified yoga therapists who delivered the yoga sessions. We summarized their experiences using recordings of the yoga sessions and interventionists' progress notes. RESULTS: Out of 7 dyads participating in the parent trial, 1 declined the videoconferenced sessions. Participants were between the ages of 55 and 76 and mostly non-Hispanic White (83%). Patients were mainly male (83%), all had stage III or IV cancer and were undergoing radiotherapy. Caregivers were all female. Despite challenges in the areas of technology, location, and setting, instruction and personal connection, the overall acceptability was high among patients, caregivers, and instructors. Through this transition process, solutions to these challenges were found, which are described here. CONCLUSION: Although in-person interventions are favored by both the study participants and the interventionists, videoconference sessions were deemed acceptable. All participants had the benefit of a previous in-person experience, which was helpful and perhaps necessary for older and advanced cancer patients requiring practice modifications. In a remote setting, the assistance of caregivers seems particularly beneficial to ensure practice safety. CLINICALTRIALS.GOV: NCT03948100; NCT02481349.

Preferences of Individuals With Cancer for Patient-Reported Outcome Measures.

PURPOSE: Symptom monitoring and management using patient-reported outcome (PRO) measures improves outcomes for individuals with cancer. The purpose of the current study was to provide a qualitative assessment of preferences of individuals with cancer for PRO measures. PARTICIPANTS & SETTING: 15 patients receiving systemic therapy at the University of Texas MD Anderson Cancer Center. METHODOLOGIC APPROACH: Participants completed three PRO measures. Qualitative interviews were conducted, and content analysis was used to identify relevant themes. FINDINGS: Identified themes were the importance of communicating various aspects of the disease and treatment experience to the oncology team, the importance of systematic PRO assessments, congruence among PRO questionnaires and questions clinicians ask at clinic visits, concerns about the length of PRO questionnaires, the importance of the response options available in PRO questionnaires, and willingness to complete PRO measures frequently. IMPLICATIONS FOR NURSING: Oncology nurses are critical facilitators of the systematic use of PRO measures across the cancer care continuum.

What Do Patients With Non-Small-Cell Lung Cancer Experience? Content Domain for the MD Anderson Symptom Inventory for Lung Cancer.

PURPOSE: Symptom monitoring has demonstrated improved outcomes in patients with cancer, including quality of life, resource utilization, ability to continue treatment, and survival. The use of disease-specific patient-reported outcome (PRO) measures facilitates symptom monitoring. While the MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC), a PRO measure of symptom burden in lung cancer, is psychometrically validated for use in patients with NSCLC, its content validity has not been verified through direct patient input. Our purpose is to describe the symptom experience of patients with NSCLC and to confirm that the MDASI-LC contains the key symptoms specific to NSCLC from the patient perspective. METHODS: Patients with NSCLC described their symptom experience in single qualitative interviews. Content analysis was used to define the content domain for a PRO measure of NSCLC symptom burden. RESULTS: Participants (N = 40) had a mean age of 66.1 years (standard deviation, 10.9 years); 60.0% were male, 77.5% were White, and 56.4% had stage IV disease. Thirty-two symptoms were described, with 6 reported by ≥ 20% of participants. Symptom variations were noted by treatment modality but not by stage of disease. Patients with NSCLC commonly reported shortness of breath, cough, distress, fatigue, pain, and constipation. In patients receiving chemotherapy, treatment-related symptoms, including neuropathy and sore mouth, were commonly noted. The presence of these symptoms resulted in interference with daily activities, relationships, life plans, treatment adherence, and mood. CONCLUSION: The symptoms included in the MDASI-LC are important components of the content domain of an NSCLC symptom burden measure. The presence of these symptoms affect daily life and, therefore, is of clinical consequence.

What symptoms are important to patients? Developing a symptom burden measure for women with breast cancer.

PURPOSE: The American Cancer Society predicted that 266,120 women would be diagnosed with breast cancer in 2018. Women experience significant symptom burden in response to tumor and treatment-related adverse effects, particularly in advanced disease. Use of valid and reliable patient-reported outcomes (PRO) symptom measures may assist clinicians in systematically monitoring and managing symptoms. The MD Anderson Symptom Inventory (MDASI) is a brief PRO measure of cancer symptom burden; specific symptoms can be added to the core symptoms to produce disease- and treatment-specific modules. The purpose of this study was to describe the patient symptom experience, define the content domain, and generate items for a breast cancer-specific MDASI module for measuring symptom burden in women with breast cancer. METHODS: Women with breast cancer were qualitatively interviewed about their experiences of disease and treatment. Descriptive exploratory analysis identified symptoms and symptom interference to define the symptom burden of breast cancer. An expert panel rated the relevance of the identified symptoms to patients with breast cancer. RESULTS: A conceptual model of breast cancer symptom burden was developed from interviews with 36 women (mean age of 57.9 years, 86.1% had stages I-III, and 52.8% were on chemotherapy and/or radiation therapy) across the breast cancer disease and treatment trajectory. Thirty-six symptoms and 6 interference categories were identified. Symptoms specific to treatment modalities and breast cancer met the criteria for inclusion in the provisional instrument for psychometric testing. CONCLUSIONS: We generated an instrument with content validity for measuring symptom burden specific to women with breast cancer.

Symptom Care at Home: A Comprehensive and Pragmatic PRO System Approach to Improve Cancer Symptom Care.

INTRODUCTION: There is growing recognition that systematically obtaining the patient's perspective on their health experience, using patient-reported outcomes (PRO), can be used to improve patient care in real time. Few PRO systems are designed to monitor and provide symptom management support between visits. Patients are instructed to contact providers between visits with their concerns, but they rarely do, leaving patients to cope with symptoms alone at home. We developed and tested an automated system, Symptom Care at Home (SCH), to address this gap in tracking and responding to PRO data in-between clinic visits. The purpose of this paper is to describe SCH as an example of a comprehensive PRO system that addresses unmet need for symptom support outside the clinic. METHODS FOR PRO SCORE INTERPRETATION: SCH uses pragmatic, single-item measures for assessing symptoms, which are commonly used and readily interpretable for both patients and providers. We established alerting values for PRO symptom data, which was particularly important for conserving oncology providers' time in responding to daily PRO data. METHODS FOR DEVELOPING RECOMMENDATIONS FOR ACTING ON PRO RESULTS: The SCH system provides automated, just-in-time self-management coaching tailored to the specific symptom pattern and severity levels reported in the daily call. In addition, the SCH system includes a provider decision support system for follow-up symptom assessment and intervention strategies. DISCUSSION: SCH provides PRO monitoring, tailored automated self-management coaching, and alerts the oncology team of poorly controlled symptoms with a provider dashboard that includes evidence-based decision support for follow-up to improve individual patients' symptom care. We particularly emphasize our process for PRO selection, rationale for determining alerting thresholds, and the design of the provider dashboard and decision support. Currently, we are in the process of updating the SCH system, developing both web-based and app versions in addition to interactive voice response phone access and integrating the SCH system in the electronic health record.

Modification of existing patient-reported outcome measures: qualitative development of the MD Anderson Symptom Inventory for malignant pleural mesothelioma (MDASI-MPM).

PURPOSE: Malignant pleural mesothelioma (MPM) is an aggressive cancer of the lung pleura. The MD Anderson Symptom Inventory (MDASI) is a patient-reported outcome (PRO) measure of symptom burden, the combined impact of disease-related and treatment-related symptoms on functioning. Validated PRO measures may require modification for use in specific study populations. We sought to modify the MDASI for patients with MPM and create a fit-for-purpose symptom-burden measure for use in a clinical trial, according to US Food and Drug Administration guidance on PRO utilization to support labeling claims. METHODS: A literature review for MPM symptoms was conducted. Patients with MPM were qualitatively interviewed about experiences of disease and treatment. Descriptive analysis identified symptoms and interference with functioning to define MPM-related symptom burden. An expert panel rated the relevance of identified symptoms to patients with MPM. Patients who received the investigational drug in a previous Phase I study were interviewed for drug-specific symptoms. RESULTS: Literature review and interviews of 20 patients identified 31 MPM-related symptoms. A conceptual model of MPM-related symptom burden was developed. After expert-panel relevance review, five MPM-specific items and the 13 core MDASI symptoms met criteria for inclusion in a provisional MDASI-MPM for psychometric testing. Interviews with six patients identified six drug-specific symptoms; three were mentioned by multiple patients. Of these three, one was not in the core MDASI. CONCLUSIONS: The MDASI-MPM has established content validity and, with the addition of one symptom item, is ready for psychometric testing as fit-for-purpose for a clinical trial of an investigational agent.