Sophie Van Tomme

Background/Objectives: Up to 95% of cancer patients report sleep disturbances or disorders. These can potentially influence cancer development and outcomes. This study aimed to review the existing literature to understand the patient experience of cancer-related sleep impairment across indications and treatments, to improve awareness and inform disease treatment/management. Methods: A targeted literature review of published qualitative studies exploring sleep impairment in oncology was conducted in MEDLINE, Embase, and PsycINFO. Concepts were extracted from the reviewed articles, and patient quotes or author descriptions/interpretations were subject to secondary analysis using semantic, qualitative, directed content analysis techniques via ATLAS.ti. Results informed the development of a patient-centric conceptual model. Results: From 482 identified publications, 22 publications were selected for in-depth review and concept extraction, collectively including 531 patients across 25 different oncology indications. Cancer-related sleep impairment frequently affected patients living with cancer, who reported difficulty obtaining good quality sleep, including difficulty falling asleep and staying asleep. Sleep problems were triggered by the emotional anxiety of life with cancer, cancer-related symptoms, treatments and side effects, and external factors. Poor sleep greatly impacted daily life for patients, with difficulties in daily life causing further sleep impairment, in a cyclical relationship. Conclusions: This study determined that there is an unmet need for treatment of sleep impairment in oncology to improve patient outcomes. The holistic conceptual model developed in this study can provide an important basis for selecting, developing, or modifying outcome measures to assess relevant sleep outcomes, facilitating discussion between patients and clinicians and improving disease treatment/management.

The literature on the qualitative experiences of patients with non-Hodgkin lymphoma (NHL) is limited. Qualitative interviews were conducted to investigate participants’ experiences with two types of NHL (diffuse large B-cell lymphoma [n = 20] and mantle cell lymphoma [n = 10]) and evaluate the comprehensiveness of patient-reported outcome (PRO) measures. Fatigue, tiredness, body aches, night sweats, lethargy, headache, appetite loss, altered taste, and weakness were the most frequent and bothersome symptoms. Key impacts were decreased physical performance, restricted activity, sadness, distress, fear of recurrence, and worry about future. Most participants expressed positive opinions about the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30 (EORTC QLQ-C30) (n = 22/28), EORTC QLQ-NHL-High Grade Module 29 (EORTC QLQ-NHL-HG29) (n = 12/16), EORTC QLQ-NHL-Low Grade Module 20 (EORTC QLQ-NHL-LG20) (n = 8/12), and Functional Assessment of Cancer Therapy–Lymphoma (FACT-Lym) (n = 10/14), considering them relevant to their experiences (22/27, 13/15, 9/13, and 10/12, respectively). All measures adequately captured their experiences with NHL (QLQ-C30: n = 26/26, NHL-HG29: n = 14/14, NHL-LG20: n = 11/11, and FACT-Lym: n = 12/13). These findings provide a valuable framework for informing the selection of appropriate PRO measures in NHL clinical trials and identifying potentially meaningful trial endpoints.

Background: Patients with advanced/metastatic melanoma experience various symptoms that significantly impact on their health-related quality of life (HRQoL). However, a comprehensive conceptual model (CM) has not been developed to capture the full spectrum of patient-reported symptoms and impacts. This study aimed to develop a patient-centered CM for advanced/metastatic melanoma.Methods: Targeted literature review and clinician interviews informed the development of a preliminary CM. To refine and finalize the CM, semi-structured interviews were conducted with US-based patients diagnosed with advanced or metastatic melanoma. Furthermore, the Functional Assessment of Cancer Therapy-Melanoma (FACT-M), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), pain Numeric Rating Scale (NRS), and itch NRS were chosen for cognitive debriefing of patients.Results: The preliminary CM was developed using 10 articles and five patient blogs. Interviews with three clinicians identified 15 priority symptoms and one key impact. Subsequently, interviews with 20 patients revealed additional 70 symptoms and 47 impacts. Frequently reported and bothersome symptoms included fatigue (n=19), lumps or nodes (n=14), fever (n=13), joint pain (n=13), changes in vision (n=13), chills (n=12), and itching (n=11). Debriefing of FACT-M, EORTC QLQ-C30, pain NRS, and itch NRS items revealed that most participants found these measures clear, easy to understand, and relevant to their experiences with advanced/metastatic melanoma.Conclusions: This study presents the first patient-informed CM for advanced/metastatic melanoma, offering a comprehensive overview of the disease- and treatment-related symptoms and impacts, which can guide the selection of meaningful outcome measures in future clinical trials.

Background and objective: Typical endpoints in cancer clinical trials focus on standardized efficacy endpoints, such as overall survival. Pain is not always assessed, although it is a highly prevalent and distressing aspect of patients’ cancer experience and plays a critical role in health-related quality of life. To inform future pain measurement strategies in oncology, this targeted literature review of pain-related qualitative publications in oncology aimed to characterize and explore the patient experience of pain, and its impact on how patients feel and function. Methods: A review of publications in MEDLINE, Embase and PsycINFO from 2018 to 2023 was conducted. Patient quotes or author descriptions/interpretations were extracted and analyzed with directed content analysis techniques, using ATLAS.ti v9. Data were synthesized to inform the development of a conceptual model. Results: Twenty-eight publications, with data from 534 patients across different oncology indications and geographies, were reviewed. Pain was triggered by disease symptoms and treatment, including surgical procedures, chemotherapy, and radiation. Pain was most often daily, severe, and chronic in nature. Characterizations of pain varied, but most often “sharp”/“stabbing”/“shooting” pain was described across different treatment stages. Pain had an extensive impact on emotional wellbeing, activities of daily living, physical, physiological and social functioning, sleep and work. Unmet needs included difficulty communicating pain needs to healthcare practitioners and fear/distrust of opioid pain medication. Conclusions: This research provides a patient-centric model conceptualizing the patient experience of cancer-related pain. The findings highlight the burden and all-encompassing impact of cancer-related pain, demonstrating the importance of assessing pain in oncology clinical trials.

Introduction Traditionally, treatment endpoints in oncology have focused on increasing overall survival and progression-free survival. Although fatigue may be a meaningful outcome measure across different cancers, it is assessed less frequently. To explore the impact of fatigue on patients with cancer, confirm the importance of fatigue measurement and inform future measurement strategies in oncology, we aimed to characterise the patient experience of fatigue and the associated impact on how patients feel and function, including aspects of health-related quality of life (HRQoL). Methods A targeted literature review of published fatigue-related qualitative publications in oncology was conducted in MEDLINE, Embase and PsycINFO, limited to studies published between 2018 and 2023. Concepts were extracted from the qualitative literature and patient quotes or author descriptions/interpretations were subject to secondary analysis using semantic, qualitative, directed content analysis techniques via ATLAS.ti v9. The literature review informed the development of a preliminary patient-centric conceptual model of fatigue in oncology. Results Of 1210 identified publications, 26 were selected for data extraction, including 512 patients living with 28 different oncology indications across geographies. Frequently reported fatigue triggers included treatments and cancer itself. Patients used various fatigue descriptors, including low/lack/loss of energy, tiredness and exhaustion, across disease stages. Physiological and cognitive manifestations of fatigue were reported, and fatigue episodes were described as unpredictable and of variable severity, duration and frequency. Cancer-related fatigue had a substantial negative effect on patients’ QoL, including emotional, physical, physiological, social, activities of daily living, sleep and work impacts. Unmet needs included poor support from healthcare professionals (HCPs). Conclusions This review demonstrated that fatigue is an impactful symptom across oncology indications and provides the first holistic conceptual model of cancer-related fatigue across disease stages and treatments. Future research should review clinical outcome assessments (COA) that may be fit-for-purpose for measuring fatigue in oncology clinical trials.