The association of cancer-related fatigue on the social, vocational and healthcare-related dimensions of cancer survivorship.

BACKGROUND: Cancer-related fatigue (CRF) is well documented in cancer survivors, but little is known about the personal and societal impact of CRF. This study aimed to examine the impact of CRF in relation to social and vocational functioning and health care utilization in a large sample of post-treatment cancer survivors. METHODS: We conducted a cross-sectional descriptive study of early stage breast and colorectal cancer survivors (n = 454) who were within 5 years from treatment completion. Social difficulties (SDI-21), work status, absenteeism and presenteeism (WHO-HPQ) and healthcare utilization (HSUQ) were compared in those with (CFR +) and without (CRF -) clinically significant fatigue (FACT-F ≤ 34). RESULTS: A total of 32% met the cut-off criteria for CRF (≤ 34). Participants with CRF + had significantly higher scores on the SDI-21 across all domains and 55% of CRF + vs. 11% in CRF - was above the SDI cut-off (> 10) for significant social difficulties. Participants with CRF + were 2.74 times more likely to be unemployed or on leave (95% CI 1.62, 4.61, p < 0.001). In the subgroup of participants who were currently working (n = 249), those with CRF + reported working on average 27.4 fewer hours in the previous 4 weeks compared to CRF - (p = 0.05), and absolute presenteeism was on average 13% lower in the CRF + group (95% CI 8.0, 18.2, p < 0.001). Finally, individuals with CRF + reported significantly more physician (p < 0.001), other health care professional (p = 0.03) and psychosocial visits (p = 0.002) in the past month. CONCLUSIONS AND IMPLICATIONS FOR CANCER SURVIVORS: CRF is associated with substantial disruption in social and work role functioning in the early transitional phase of cancer survivorship. Better management of persistent CRF and funding for the implementation of existing guidelines and recommended evidence-based interventions are urgently needed.

Preexisting mental health disorders and risk of opioid use disorder in young people: A case-control study.

AIM: Opioid use disorder (OUD) is a leading cause of preventable mortality amongst young people worldwide. Early identification and intervention of modifiable risk factors may reduce future OUD risk. The aim of this study was to explore whether the onset of OUD is associated with preexisting mental health conditions such as anxiety and depressive disorders in young people. METHODS: A retrospective, population-based case-control study was conducted from 31 March 2018 until 01 January 2002. Provincial administrative health data were collected from Alberta, Canada. CASES: Individuals 18-25 years on 01 April 2018, with a previous record of OUD. CONTROLS: Individuals without OUD were matched to cases, on age/sex/index date. Conditional logistic regression analysis was used to control for additional covariates (e.g., alcohol-related disorders, psychotropic medications, opioid analgesics, and social/material deprivation). RESULTS: We identified N = 1848 cases and N = 7392 matched controls. After adjustment, OUD was associated with the following preexisting mental health conditions: Anxiety disorders, aOR = 2.53 (95% CI = 2.16-2.96); depressive disorders, aOR = 2.20 (95% CI = 1.80-2.70); alcohol-related disorders, aOR = 6.08 (95% CI, 4.86-7.61); anxiety and depressive disorders, aOR = 1.94 (95% CI = 1.56-2.40); anxiety and alcohol-related disorders, aOR = 5.22 (95% CI = 4.03-6.77); depressive and alcohol-related disorders, aOR = 6.47 (95% CI = 4.73-8.84); anxiety, depressive and alcohol-related disorders, aOR = 6.09 (95% CI = 4.41-8.42). DISCUSSION: Preexisting mental health conditions such as anxiety and depressive disorders are risk factors for future OUD in young people. Preexisting alcohol-related disorders showed the strongest association with future OUD and demonstrated an additive risk when concurrent with anxiety/depression. As not all plausible risk factors could be examined, more research is still needed.

Exploring patient centredness, communication and shared decision-making under a new model of care: Community rehabilitation in canada.

Patient-centred care and patient engagement in healthcare and health research are widely mandated by funders, health systems and institutions. Increasingly, shared decision-making (SDM) is recognised as promoting patient-centred care. We explore this relationship by studying SDM in the context of integrating novel patient-centred policies in community rehabilitation. There is little research on SDM in rehabilitation, and less so in the critical community context. Patient co-investigators led study co-design. We aimed to describe how patients and providers experience SDM at community rehabilitation sites that adopted a novel, patient-centred Rehabilitation Model of Care (RMoC). Guided by focused ethnography, we conducted focus groups and interviews. Patient and professional participants were recruited from 10 RMoC early-adopter community rehabilitation sites. Sites varied in geography, patient population and provider disciplines. Patient and community engagement researchers used a set-collect-reflect method to document patient perspectives. Researchers captured provider perspectives using a semi-structured question guide. We completed 11 focus groups and 18 interviews (n = 45 providers, n = 17 patients). We found that most early-adopter providers spoke in a shared, patient-first language that focused on patient readiness, barriers and active listening. Congruent patient perceptions reflected inclusion in decision-making, goal setting and positive relationships. Many patients queried how care would become and remain accessible before and after community rehabilitation care respectively. Remaining connected while in the community was described as important to patients. Providers identified barriers like time, team dynamics and lack of clarity on the RMoC aims, which challenged the initiative's long-term sustainability. Policy innovations can promote SDM and communication through multiple strategies and training to facilitate candid, encouraging conversations. Sustainability of SDM gains is paramount. Most providers moved beyond tokenistic engagement, but competing responsibilities and team member resistance could thwart continuity. Further research is needed to empirically assess respectful and compassionate communication and SDM in community rehabilitation long term.

Treatment options and shared decision-making in the treatment of opioid use disorder: A scoping review.

BACKGROUND: Shared decision-making (SDM) is an approach to clinical decision-making that includes patients' values and preferences during health-related decisions. Previous research suggests that SDM may be beneficial in the treatment of substance use disorders; however, the impact of SDM in the treatment of opioid use disorder (OUD) remains unclear. OBJECTIVES: To identify relevant peer-reviewed literature related to SDM in the treatment of adults with OUD, and to summarize the main findings according to patient outcomes. METHODS: The research team conducted a scoping review. The team searched five electronic health databases from database inception until September 2019 using MeSH and keywords related to SDM. The team included only peer-reviewed studies where adults (≥18 years) with OUD were provided a choice and/or allowed input into their treatment plan. Two independent reviewers screened, extracted, and assessed the quality of included studies. RESULTS: Fourteen studies (n = 1748 participants) met inclusion criteria, including seven randomized controlled trials, three non-randomized controlled trials, two observational studies, and one qualitative study. Treatment options included: patient regulated methadone dosing vs. fixed dosing (n = 4 studies), optional vs. mandatory counseling (n = 4 studies), home vs. office buprenorphine inductions (n = 2 studies), and inpatient vs. outpatient treatment (n = 1 study). None of the studies measured SDM with a validated instrument. Seven of 14 studies reported at least one improved patient outcome. CONCLUSIONS: The review found few studies that explored whether providing treatment options and/or encouraging participation in decision-making are beneficial for adults with OUD. Preliminary evidence suggests that SDM may be promising for this population. However, the field needs more research on person-centered care and SDM.

Systematic Review of Mind-Body Interventions to Treat Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.

Background and Objectives: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a chronic condition distinguished by disabling fatigue associated with post-exertional malaise, as well as changes to sleep, autonomic functioning, and cognition. Mind-body interventions (MBIs) utilize the ongoing interaction between the mind and body to improve health and wellbeing. Purpose: To systematically review studies using MBIs for the treatment of ME/CFS symptoms. Materials and Methods: MEDLINE, EMBASE, CINAHL, PsycINFO, and Cochrane CENTRAL were searched (inception to September 2020). Interventional studies on adults diagnosed with ME/CFS, using one of the MBIs in comparison with any placebo, standard of care treatment or waitlist control, and measuring outcomes relevant to the signs and symptoms of ME/CFS and quality of life were assessed for inclusion. Characteristics and findings of the included studies were summarized using a descriptive approach. Results: 12 out of 382 retrieved references were included. Seven studies were randomized controlled trials (RCTs) with one including three reports (1 RCT, 2 single-arms); others were single-arm trials. Interventions included mindfulness-based stress reduction, mindfulness-based cognitive therapy, relaxation, Qigong, cognitive-behavioral stress management, acceptance and commitment therapy and isometric yoga. The outcomes measured most often were fatigue severity, anxiety/depression, and quality of life. Fatigue severity and symptoms of anxiety/depression were improved in nine and eight studies respectively, and three studies found that MBIs improved quality of life. Conclusions: Fatigue severity, anxiety/depression and physical and mental functioning were shown to be improved in patients receiving MBIs. However, small sample sizes, heterogeneous diagnostic criteria, and a high risk of bias may challenge this result. Further research using standardized outcomes would help advance the field.

A journey through roses and thorns: becoming a physician by learning from patients with life-threatening illnesses. A qualitative study with international medical students.

The medical students' well-being may be threatened by various stressors associated with providing care to different kinds of patients. This study aims to explore students' clinical experiences with patients who suffer from life-threatening illnesses, focusing on potential risk and protective factors. Audio-recorded and face-to-face interviews were conducted and transcribed verbatim. The "Interpretive Description" approach was used to analyse data. Overall, ten medical students with a mean age of 28 years old were interviewed. Well-being promoting factors were the following: therapeutic relationships, work-life balance, social support and communication, perception of improvement in knowledge and availability of advanced directives. Whilst factors that may reduce well-being included death exposure, managing emotions, communication difficulties, internal conflicts and disagreements, lack of knowledge and subjective concerns. These findings shed light on facets that are inherent parts of clinical experience with patients suffering from a life-threatening illness and that may turn in risk or protective factors for the medical students. Understanding the students' subjective experiences may aid in the improvement of the current educational programs, as well as in the development of tailored supportive and preventative interventions to promote well-being and professional competencies among this kind of students.

Implementation of a novel rehabilitation model of care across Alberta, Canada: a focused ethnography.

BACKGROUND: In 2017, a provincial health-system released a Rehabilitation Model of Care (RMoC) to promote patient-centred care, provincial standardisation and data-driven innovation. Eighteen early-adopter community-rehabilitation teams implemented the RMoC using a 1.5-year-long Innovation Learning Collaborative (in-person learning sessions; balanced scorecards). More research is required on developing, implementing and evaluating models of care. We aimed to explore experiences of early-adopter providers and provincial consultants involved in the community-rehabilitation RMoC implementation in Alberta, Canada. METHODS: Using focused ethnography, we used focus groups (or interviews for feasibility/confidentiality) and aggregate, site-level data analysis of RMoC standardised metrics. Purposive sampling ensured representation across geography, service types and patient populations. Team-specific focus groups were onsite and led by a researcher-moderator and cofacilitator. A semistructured question guide promoted discussions on interesting/challenging occurrences; perceptions of RMoC impact and perceptions of successful implementation. Focus groups and interviews were audio-recorded and transcribed alongside field notes. Data collection and analysis were concurrent to saturation. Transcripts coding involves collapsing similar ideas into themes, with intertheme relationships identified. Rigour tactics included negative case analysis, thick description and audit trail. RESULTS: We completed 11 focus groups and seven interviews (03/2018 to 01/2019) (n=45). Participants were 89.6% women, mostly Canadian trained and represented diverse rehabilitation professions. The implementation experience involved navigating emotions, operating among dynamics and integrating the RMoC details. Confident, satisfied early-adopter teams demonstrated traits including strong coping strategies; management support and being opportunistic and candid about failure. Teams faced common challenges (eg, emotions of change; delayed data access and lack of efficient, memorable communication across team and site). Implementation success targeted patient, team and system levels. CONCLUSIONS: We recommend training priorities for future teams including evaluation training for novice teams; timelines for stepwise implementation; on-site, in-person time with a facilitator and full-team present and prolonged facilitated introductions between similar teams for long-term mentorship.

Oligoanalgesia in Adult Colles Fracture Patients Admitted to the Emergency Department.

Pain is a complex symptom to assess properly and it is often poorly managed in the Emergency Department. The majority of research has focused on exploring oligoanalgesia in samples of patients with heterogeneous injuries. The occurrence of oligoanalgesia in a homogeneous injury, such as Colles fracture, has yet to be explored. A retrospective chart review was conducted to determine the incidence of oligoanalgesia in adults with Colles fractures admitted to two urban Emergency Departments in Western Canada. Data were collected from one hundred fifty charts from a 5-year period (2009-2014). Age and gender predicted of pain assessment (p = .019), but were not significantly associated with receipt of an opioid or pain reassessment. Pain reassessment was only completed in 47% of patients who received an initial pain assessment; this was significantly different from current best practice standards (p = .0002).

Cancer-related cognitive impairment in patients with non-central nervous system malignancies: an overview for oncology providers from the MASCC Neurological Complications Study Group.

Cancer-related cognitive impairment (CRCI) is commonly experienced by individuals with non-central nervous system cancers throughout the disease and treatment trajectory. CRCI can have a substantial impact on the functional ability and quality of life of patients and their families. To mitigate the impact, oncology providers must know how to identify, assess, and educate patients and caregivers. The objective of this review is to provide oncology clinicians with an overview of CRCI in the context of adults with non-central nervous system cancers, with a particular focus on current approaches in its identification, assessment, and management.

Effectiveness of hospital clowns for symptom management in paediatrics: systematic review of randomised and non-randomised controlled trials.

OBJECTIVE: To evaluate evidence from randomised controlled trials and non-randomised controlled trials on the effectiveness of hospital clowns for a range of symptom clusters in children and adolescents admitted to hospital with acute and chronic conditions. DESIGN: Systematic review of randomised and non-randomised controlled trials. DATA SOURCES: Medline, ISI of Knowledge, Cochrane Central Register of Controlled Trials, Science Direct, Scopus, American Psychological Association PsycINFO, Cumulative Index to Nursing and Allied Health Literature, and Latin American and Caribbean Health Sciences Literature. STUDY SELECTION: Randomised and non-randomised controlled trials were peer reviewed using the following eligibility criteria: children and adolescents who were admitted to hospital for acute conditions or chronic disorders, studies comparing use of hospital clowns with standard care, and studies evaluating the effect of hospital clowns on symptom management of inpatient children and adolescents as a primary outcome. DATA EXTRACTION AND SYNTHESIS: Two investigators independently screened studies, extracted data, and appraised the risk of bias. Methodological appraisal was assessed by two investigators independently using the Jadad scale, the revised Cochrane risk-of-bias tool for randomised controlled trials (RoB 2), and the risk of bias in non-randomised studies (ROBINS-I) tool for non-randomised controlled trials. RESULTS: 24 studies (n=1612) met the inclusion criteria for data extraction and analysis. Most studies were randomised controlled trials (n=13). Anxiety was the most frequently analysed symptom (n=13), followed by pain (n=9), psychological and emotional responses and perceived wellbeing (n=4), stress (n=4), cancer related fatigue (n=3), and crying (n=2). Five studies used biomarkers, mainly cortisol, to assess stress or fatigue outcome following hospital clowns. Most of the randomised controlled trials (n=11; 85%) were rated as showing some concerns, and two trials were rated with a high risk of bias. Most non-randomised controlled trials (n=6; 55%) were rated with a moderate risk of bias according to ROBINS-I tool. Studies showed that children and adolescents who were in the presence of hospital clowns, either with or without a parent present, reported significantly less anxiety during a range of medical procedures, as well as improved psychological adjustment (P<0.05). Three studies that evaluated chronic conditions showed favourable results for the intervention of hospital clowns with significant reduction in stress, fatigue, pain, and distress (P<0.05). CONCLUSIONS: These findings suggest that the presence of hospital clowns during medical procedures, induction of anaesthesia in the preoperative room, and as part of routine care for chronic conditions might be a beneficial strategy to manage some symptom clusters. Furthermore, hospital clowns might help improve psychological wellbeing in admitted children and adolescents with acute and chronic disorders, compared with those who received only standard care. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018107099.

Measuring shared decision-making and collaborative goal setting in community rehabilitation: a focused ethnography using cross-sectional surveys in Canada.

OBJECTIVE: To describe and measure the shared decision-making (SDM) experience, including goal-setting experiences, from the perspective of patients and providers in diverse community-rehabilitation settings. DESIGN: Prospective, longitudinal surveys. SETTING: 13 primary level-of-care community-rehabilitation sites in diverse areas varying in geography, patient population and provider discipline341 adult, English-speaking patient-participants, and 66 provider-participants. MEASURES: Alberta Shared decision-maKing Measurement Instrument (dyadic tool measuring SDM), WatLX (outpatient rehabilitation experience) and demographic questionnaire. Survey packages distributed at two timepoints (T0=recruitment; T1=3 months later). RESULTS: We found that among 341 patient-provider dyads, 26.4% agreed that the appointment at recruitment involved high-quality SDM. Patient perceptions of goal-setting suggested that 19.6% of patients did not set a goal for their care, and only 11.4% set goals in functional language that tied directly to an activity/role/responsibility that was meaningful to their life. Better SDM was clinically associated with higher total family income (p=0.045). CONCLUSIONS: These findings provide evidence for the importance of SDM and goal setting in community rehabilitation. Among patients, lower ratings of SDM corresponded with less recognition of their preferences. Actionable strategies include supporting financially vulnerable patients in realising SDM through training of providers to make extra space for such patients to share their preferences and better preparing patients to articulate their preferences. We recommend more research into strategies that advance highly functional goal setting with patients, and that lessen survey ceiling effects.

Patient Portal Implementation and Uptake: Qualitative Comparative Case Study.

BACKGROUND: Giving patients access to their health information is a provincial and national goal, and it is critical to the delivery of patient-centered care. With this shift, patient portals have become more prevalent. In Alberta, the Alberta Health Services piloted a portal (MyChart). There was a need to identify factors that promoted the use of this portal. Furthermore, it was imperative to understand why there was variability in uptake within the various clinics that participated in the pilot. OBJECTIVE: This study aims to identify potential factors that could improve the uptake of MyChart from the perspectives of both users and nonusers at pilot sites. We focused on factors that promoted the use of MyChart along with related benefits and barriers to its use, with the intention that this information could be incorporated into the plan for its province-wide implementation. METHODS: A qualitative comparative case study was conducted to determine the feasibility, acceptability, and initial perceptions of users and to identify ways to increase uptake. Semistructured interviews were conducted with 56 participants (27 patients, 21 providers, 4 nonmedical staff, and 4 clinic managers) from 5 clinics. Patients were asked about the impact of MyChart on their health and health care. Providers were asked about the impact on the patient-provider relationship and workflow. Managers were asked about barriers to implementation. The interviews were recorded, transcribed verbatim, and entered into NVivo. A thematic analysis was used to analyze the data. RESULTS: Results from a comparison of factors related to uptake of MyChart in 5 clinics (2 clinics with high uptake, 1 with moderate uptake, 1 with low uptake, and 1 with no uptake) are reported. Some theoretical constructs in our study, such as intention to use, perceived value, similarity (novelty) of the technology, and patient health needs, were similar to findings published by other research teams. We also identified some new factors associated with uptake, including satisfaction or dissatisfaction with the current status quo, performance expectancy, facilitating conditions, behavioral intentions, and use behavior. All these factors had an impact on the level of uptake in each setting and created different opportunities for end users. CONCLUSIONS: There is limited research on factors that influence the uptake of patient portals. We identified some factors that were consistent with those reported by others but also several new factors that were associated with the update of MyChart, a new patient portal, in the clinics we studied. On the basis of our results, we posit that a shared understanding of the technology among patients, clinicians, and managers, along with dissatisfaction with nonportal-based communications, is foundational and must be addressed for patient portals to support improvements in care.

Tracing the Decisions That Shaped the Development of MyChart, an Electronic Patient Portal in Alberta, Canada: Historical Research Study.

BACKGROUND: Understanding how health organizations decide on information technology (IT) investments is imperative to ensure successful implementation and adoption. There is a high rate of failure and a tendency to downplay the complexity of implementation progression. Alberta Health Services introduced a patient portal called MyChart. Although MyChart allows patients to view appointments and selected laboratory results and to communicate with their providers, its uptake varies. OBJECTIVE: The study aimed to examine the institutional decision-making processes that shaped the development and implementation of MyChart. METHODS: A historical study was conducted based on the 7-step framework, where one engages in a rigorous archival critical analysis (including internal and external criticism) of documents and analysis of interviews. We reviewed and analyzed 423 primary and secondary sources and interviewed 10 key decision makers. RESULTS: Supportive leadership, project management, focused scope, appropriate technology and vendor selection, and quick decision making were some of the facilitators that allowed for the growth of proof of concept. The planning and implementation stages did not depend much on the technology itself but on the various actors who influenced the implementation by exerting power. The main barriers were lack of awareness about the technology, proper training, buy-in from diverse system leaders, and centralized government decision making. CONCLUSIONS: Organizational priorities and decision-making tactics influence IT investments, implementation, adoption, and outcomes. Future research could focus on improving the applicability of needs assessments and funding decisions to health care scenarios.

Experiences of shared decision-making in community rehabilitation: a focused ethnography.

BACKGROUND: Shared decision-making (SDM) can advance patient satisfaction, understanding, goal fulfilment, and patient-reported outcomes. We lack clarity on whether this physician-focused literature applies to community rehabilitation, and on the integration of SDM policies in healthcare settings. We aimed to understand patient and provider perceptions of shared decision-making (SDM) in community rehabilitation, particularly the barriers and facilitators to SDM. METHODS: We used a focused ethnography involving 14 community rehabilitation sites across Alberta, including rural, regional-urban and metropolitan-urban sites. We conducted semi-structured interviews that asked participants about their positive and negative communication experiences (n = 23 patients; n = 26 providers). RESULTS: We found SDM experiences fluctuated between extremes: Getting Patient Buy-In and Aligning Expectations. The former is provider-driven, prescriptive and less flexible; the latter is collaborative, inquisitive and empowering. In Aligning Expectations, patients and providers express humility and openness, communicate in the language of ask and listen, and view education as empowering. Patients and providers described barriers and facilitators to SDM in community rehabilitation. Facilitators included geography influencing context and connections; consistent, patient-specific messaging; patient lifestyle, capacity and perceived outlook; provider confidence, experience and perceived independence; provider training; and perceptions of more time (and control over time) for appointments. SDM barriers included lack of privacy; waitlists and financial barriers to access; provider approach; how choices are framed; and, patient's perceived assertiveness, lack of capacity, and level of deference. CONCLUSIONS: We have found both excellent experiences and areas for improvement for applying SDM in community rehabilitation. We proffer recommendations to advance high-quality SDM in community rehabilitation based on promoting facilitators and overcoming barriers. This research will support the spread, scale and evaluation of a new Model of Care in rehabilitation by the provincial health system, which aimed to promote patient-centred care.

Clown Intervention on Psychological Stress and Fatigue in Pediatric Patients With Cancer Undergoing Chemotherapy.

BACKGROUND: Clown intervention has been shown to enhance emotional and behavioral processes, but few studies have comprehensively examined the effectiveness of this practice using biomarkers. OBJECTIVE: The aim of this study was to evaluate the effect of a clown intervention on the levels of psychological stress and cancer-related fatigue in pediatric patients with cancer undergoing chemotherapy. METHODS: Sixteen patients who met all criteria from a pediatric oncology inpatient unit in a Brazilian comprehensive cancer care hospital participated in this quasi-experimental study. Eight saliva samples were collected, comprising 4 at baseline and 4 after clown intervention (+1, +4, +9, and +13 hours after awakening). Salivary cortisol and α-amylase levels were determined using high-sensitivity enzyme-linked immunosorbent assay kits. Stress and fatigue were measured by the Child Stress Scale-ESI and the PedsQL Multidimensional Fatigue Scale, respectively. Relationships among stress, fatigue, and biomarker levels were investigated using nonparametric statistics. RESULTS: In comparison with baseline measurements, the total psychological stress and fatigue levels improved after the clown intervention at the collection time point +4 hours (P = .003 and P = .04, respectively). Salivary cortisol showed a significant decrease after clown intervention at the collection time points +1, +9, and +13 hours (P < .05); however, α-amylase levels remained unchanged. CONCLUSION: These findings provide preliminary evidence that clown intervention merits further study as a way to reduce stress and fatigue in pediatric cancer inpatients, and that self-report and biomarker measures are feasible to collect in this patient group. IMPLICATIONS FOR PRACTICE: Clown intervention as a nonpharmacological intervention may improve stress and fatigue levels in pediatric inpatients with cancer undergoing chemotherapy.

Association of plasma leptin, pro-inflammatory adipokines and cancer-related fatigue in early-stage breast cancer patients: A prospective cohort study.

Cancer-related fatigue (CRF) is subjective and has wide inter-individual variability. Given that leptin is commonly associated with fatigue syndrome, its use as a potential biomarker for CRF is being investigated. The primary objective of this study was to evaluate the association between leptin and CRF in early-stage breast cancer patients receiving chemotherapy. In a prospective cohort study, patients completed assessments at baseline (T1), during chemotherapy (T2) and after chemotherapy (T3). Levels of plasma leptin and adipokines were measured using a Luminex bead-immunoassay and CRF was measured using the Multi-Dimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). Data were analysed longitudinally using a generalised estimating equation incorporating clinically relevant parameters and pro-inflammatory adipokines. The analysis included 136 patients (mean age ± SD = 51.5 ± 8.8 years; 69.1% receiving anthracycline-based chemotherapy). More patients experienced CRF at T3 (23.8%) than at T2 (13.8%) compared to baseline. An increase was observed in the median plasma leptin level at T2, followed by a decrease at T3 (T1: 4.07 ng/mL, T2: 4.95 ng/mL and T3: 3.96 ng/mL). In the multivariate model, the change in leptin levels over time was significantly associated with the total MFSI-SF score (ß = -0.15, P = 0.003) after adjusting for the tumour necrosis factor-α (TNF-α) level, anxiety, depression, insomnia, age, menopausal status and type of chemotherapy. This is the first study to report leptin as a biomarker that predicts the onset of CRF over time. Future studies are required to validate the findings.