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.

The present study aimed to explore the patient experience in advanced and/or metastatic hepatocellular carcinoma (HCC). A multi-phase research design was followed that included a targeted literature review (TLR), interviews with clinicians, and interviews with patients. Patient interviews were analyzed using an iterative, thematic analysis approach. An assessment of the conceptual saturation of all spontaneously patient-reported signs and symptoms was conducted. Ten patient-centric qualitative studies were identified in the TLR. Five United States (US) clinicians and 15 US patients participated in semi-structured interviews, conducted via video conferencing, lasting approximately 60 minutes each. The five most commonly reported symptoms were fatigue, weight loss, weakness, reduction in appetite, and sleep disturbance. Furthermore, HCC impacted all aspects of patients' lives, including physical functioning, social and family functioning, emotional functioning, physical activities, and activities of daily living. The concepts were mostly similar across the different data sources. A patient-centric conceptual model was developed based on the TLR and patient interviews. The study provides an in-depth description of signs/symptoms and impacts in advanced and/or metastatic HCC that can support the identification of suitable patient-reported outcome measures. Separate investigation is needed to distinguish between disease impacts and treatment impacts.

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.

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.