Multidimensional Fatigue Symptom Inventory-Short Form Research Articles

Physical activity and dexamethasone for cancer related fatigue: A preliminary placebo controlled randomized control trial.

12050 Background: Despite high frequency and significant impact on quality of life, there are limited treatment options available for cancer related fatigue (CRF) in patients with advanced cancer. The primary aim of the study was to determine the feasibility (adherence, safety, and satisfaction) of the combination therapy, physical activity (PA) plus Dexamethasone (Dex); and PA plus placebo (Pl) for CRF. The secondary aim was to explore the effects of PA+Dex, and PA+Pl on CRF as assessed by Functional Assessment of Cancer Illness Therapy–fatigue (FACIT-F). Methods: In this phase 2, randomized, double blind, placebo controlled trial, patients with advanced cancer with CRF ≥ 4/10 on Edmonton Symptom Assessment Scale were eligible. Patients were randomized to standardized PA for 4 weeks plus either 4mg of Dex (PA+Dex arm), or Pl (PA+PL arm) BID for the first 7 days. Changes in FACIT-F scores from baseline to Day 8, and Day 29 were assessed. Other outcomes included change in quality-of-life scores. Results: A total of64 (89%) patients were evaluable. The median (IQR) changes in FACIT-F scores at Day 8 and Day 29 from baseline were 9 (2,16), P< 0.001; 5.75 (0,12.5), P=0.015 for PA+ Dex arm, and 3.5 (-2.13, 10), P=0.054; 6.50 (2.5, 15.5), P=0.006 for PA+ Pl arm respectively. Exploratory Linear Mixed Model (LMM) analysis showed significant treatment effect of PA +Dex, with treatment having improvement of 5.63 units for FACIT-F scores (95% Cl 1.74,9.52), P=0.005. Effect sizes for improvement of FACIT-F scores at Day 8 and Day 29 were -3.49, -2.43 in PA+Dex arm; and -1.93, -2.72 in PA+Pl arm, respectively. Effect sizes for change in fatigue related symptoms and quality of life scores as assessed by Patient-Reported Outcome Measurement Information System-Fatigue T-scores, Multidimensional Fatigue Symptom Inventory-Short Form total, and Functional Assessment of Cancer Therapy -General scores at Day 8, and Day 29 in PA+ Dex arm were 2.93 (P=0.005), 2.82 (P=0.005); 2.27 (P=0.023), 2.68 (P=0.007); -2.39 (P=0.017), -3.26 (P=0.001) respectively. Adherence to Dex and Pl were 91% and 92%, respectively, Satisfaction rates with PA+Dex and PA+Pl arms were 98% and 79%, respectively. There was no significant difference in grade ≥3 adverse events between the two arms (P = 0.36). Conclusions: Satisfaction, and tolerability to the combination therapy, and medication adherence was excellent.PA + Dex significantly improved CRF at day 8 and 29. The improvement was sustained 3 weeks after discontinuation of Dex. Further larger studies are justified. Clinical trial information: NCT03583255 .

Minimal clinically important differenceof fatigue severity scale in patients with chronic stroke

BackgroundOne of the most prevalent symptoms of stroke is fatigue. Fatigue severity scale is the most often used tool for evaluating fatigue in stroke patients, its minimal clinically important difference threshold has not been determined. This study aimed to identify the minimal clinically important difference of fatigue severity scale in stroke patients. MethodsAll study participants were examined using fatigue severity scale and multidimensional fatigue symptom inventory-short form before and after the intervention. The 6-week intervention combined graded activity training and pacing therapy employed to reduce fatigue severity. Participants reported changes in their fatigue severity after the intervention with the global rating of change and visual analog scale. The minimal clinically important difference of the fatigue severity scale calculated using both anchor- and distribution-based methods. ResultsA total of 117 stroke patients were included in the study. Using multidimensional fatigue symptom inventory-short form, global rating of change, and visual analog scale as an anchor, the minimal clinically important difference of fatigue severity scale was obtained at 3.5, 4.5, and 4.5, respectively. The minimal clinically important difference for fatigue severity scale varied from 4.28 to 12.90 using the distribution-based method, with SEM = 4.28 displaying the best sensitivity and specificity for use as minimal clinically important difference. ConclusionsThe minimal clinically important difference value for the fatigue severity scale was estimated at 3.5_12.90 using anchor-based and distribution-based methods. The study's results can be utilized to understand the effectiveness of fatigue interventions in stroke patients in clinical and research settings

17 Comparing Cognitive Patient-Reported Outcomes with Neuropsychological Impairment in Patients with Diffuse Glioma.

Objective:Cognitive difficulties among diffuse glioma survivors are common in survivorship due to cancer treatment effects (i.e., surgery, chemotherapy, and/or radiation therapy), which can diminish quality of life. Routine monitoring of cognitive symptoms in survivorship is recommended and can help address patient needs and inform clinical interventions (e.g., cognitive rehabilitation). While several patient-reported outcome (PRO) measures have been used in brain tumor populations, there has been few studies comparing the performance of these PROs in patients with diffuse glioma. In order to better understand the value of different PROs, we conducted preliminary analyses associating cognitive PROs with neuropsychological impairment in a well-characterized sample of patients with diffuse glioma.Participants and Methods:23 glioma patients (mean aged 44.26 ± 12.24), six or more months after completing cancer treatment, underwent comprehensive psychosocial and neuropsychological assessments. The neuropsychological battery included the Hopkins Verbal Learning Test - Revised, Brief Visuospatial Memory Test - Revised, Wechsler Adult Intelligence Scale-IV tests of Coding and Digit Span, Trail-Making Test, Stroop Test, FAS, Animals, Boston Naming Test, and Rey-Osterrieth Complex Figure (copy). Completed cognitive PROs included the Functional Assessment of Cancer - Cognitive Function and Brain questionnaires (FACT-Cog; FACT-Br), the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire for Brain Neoplasms (EORTC QLQ-BN20), and the Multidimensional Fatigue Symptom Inventory, short form (MFSI-SF) Mental subscale. Based on published norms, we divided the sample into cognitively impaired and non-impaired groups (two or more primary neuropsychological test scores <= -2 z-score). We compared PRO scores between impaired and non-impaired groups using Mann-Whitney U tests. Higher medians equate to better cognitive functioning for all PROs, except for the MSFI-SF.Results:We found significantly worse scores in the impaired group compared to non-impaired group on the FACT-Cog subscales of perceived cognitive ability (PCA), [Non-Impaired (Mdn = 21, n = 11), Impaired (Mdn = 10, n = 12), U = 22.5, z = -2.68, = 0.007], perceived cognitive impairment (PCI), [Non-Impaired (Mdn = 59, n = 11), Impaired (Mdn = 44, n = 12), U = 32.5, z = -2.06, p=0.039]. The impaired group also trended towards worse scores on the FACT-Br additional concerns subscale [Non-Impaired (Mdn = 79.5, n = 10), Impaired (Mdn = 61, n = 12), U = 32.5, z = -1.81, p=0.07]. Group differences were not observed on the MSFI-SF [Non-Impaired (Mdn = 5, n = 11), Impaired (Mdn = 7, n = 12), U = 40.5, z = -1.57, p=0.12], or EORTC Cognitive Functioning subscale [Non-Impaired (Mdn = 83.33, n = 10), Impaired (Mdn = 75, n = 12), U = 42, z = -1.23, p=0.218].Conclusions:The preliminary findings suggest that the FACT-Cog, especially the PCA and PCI correspond with neuropsychological impairment among diffuse glioma survivors better than other cognitive PROs. The FACT-Br subscale was somewhat effective. The MFSI-SF Mental and EORTC Cognitive Functioning subscales did not correspond to impairment status. The FACT-Cog is a promising instrument and future work is needed to better determine relative utility of cognitive PROs in this population.

ACTivity as medicine In Oncology for Head and Neck (ACTIOHN): Protocol for a feasibility study investigating a patient-centred approach to exercise for people with head and neck cancer.

Attempts at personalisation of exercise programmes in head and neck cancer (HaNC) have been limited. The main aim of the present study is to investigate the feasibility and acceptability of introducing a remotely delivered, fully personalised, collaborative, and flexible approach to prescribing and delivering exercise programmes into the HaNC usual care pathway. This is a single arm, feasibility study. Seventy patients diagnosed with HaNC will be recruited from two regional HaNC centres in the United Kingdom. Patients will undertake an 8-week exercise programme designed and delivered by cancer exercise specialists. The exercise programme will start any time between the time of diagnosis and up to 8 weeks after completing treatment, depending on patient preference. The content of the exercise programme will be primarily based on patient needs, preferences, and goals, but guided by current physical activity guidelines for people with cancer. The primary outcome measure is retention to the study. Secondary quantitative outcomes are uptake to the exercise programme, different measures of exercise adherence, pre- and post-intervention assessments of fatigue (Multidimensional Fatigue Symptom Inventory-Short Form), quality of life (SF-36), physical activity levels (International Physical Activity Questionnaire-Short Form), and various components of physical fitness. The outcomes of the nested qualitative study are acceptability and feasibility of the intervention evaluated via interviews with patients, health care professionals, and the cancer exercise specialists. Intervention and participant fidelity will be determined using checklists and scrutiny of each patient's logbook and the cancer exercise specialists' meeting notes. Analysis of quantitative data will be via standard summary statistics. Qualitative data will be analysed using thematic analysis. This feasibility study will inform the design and conduct of a future randomised controlled trial. Success will be defined according to a traffic light system for identifying the appropriateness of progression to a randomised controlled trial. International Standard Randomised Controlled Trial Number registry (ISRCTN82505455).

Persian version of the Chalder Fatigue Questionnaire and Multidimensional Fatigue Symptom Inventory-Short Form: psychometric properties in Iranian chronic stroke survivors

ABSTRACT Background Post-stroke fatigue is a disturbing condition with various physical and psychological facets, which needs to be assessed by meaningful and psychometrically valid and reliable tools. The Chalder Fatigue Questionnaire (CFQ) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) have been designed to assess diverse dimensions of fatigue. Objectives The present study aimed to investigate the psychometric properties of the CFQ and MFSI-SF in people with chronic stroke. Methods Both measures were translated according to forward-backward standard protocol. This cross-sectional study was conducted with 130 first-time stroke survivors. The multidimensional fatigue inventory, checklist individual strength, fatigue assessment scale, fatigue subscale of profiles of mood state, fatigue severity scale, visual analogue scale-fatigue, beck anxiety inventory, center for epidemiologic studies of depression scale, and 36-item short-form health survey were administered in addition to the CFQ and MFSI-SF. Reliability, precision, known-groups validity, and convergent validity were examined for the CFQ and MFSI-SF. Results The results showed an acceptable (Cronbach’s alpha = 0.81–0.97) internal consistency and test–retest reliability (intra-class correlation = 0.75–0.97). The CFQ and MFSI-SF revealed good ability (P < 0.001) to differentiate chronic stroke survivors with different disability levels. Significant high correlation (P = −0.61–0.87) was found between CFQ and MFSI-SF and other fatigue scales. Conclusions The results of this study showed that the CFQ and MFSI-SF have high reliability and validity for chronic stroke survivors.

European Portuguese Version of the Multidimensional Fatigue Symptom Inventory-Short Form: Validation Study.

Appropriate management of fatigue relies upon comprehensive assessment instruments and timely delivery of targeted interventions. The aims of this study were to translate a commonly used English-language measure of fatigue in cancer patients (the Multidimensional Fatigue Symptom Inventory-Short-Form, or MFSI-SF) into European Portuguese and to evaluate the psychometric properties (internal consistency reliability, factorial structure, and discriminant, convergent and criterion concurrent validity) of the translated measure for use with Portuguese patients. After translation and adaptation of the MFSI-SF to European Portuguese, 389 participants (68.38% women), with a mean age of 59.14 years, completed the study protocol. This sample included 148 patients in active cancer treatment from a cancer center and a community sample composed of 55 cancer survivors, 75 patients with other chronic diseases, and 111 healthy controls. The European Portuguese version of the Multidimensional Fatigue Symptom Inventory-Short Form (IMSF-FR) showed strong internal consistency (Cronbach's alpha = 0.97, McDonald's omega = 0.95). An exploratory factor analysis indicated that the items loaded in a 5-factor model in subscales were similar to the original version. Strong correlations between the IMSF-FR and other measures of fatigue and vitality confirmed convergent validity. Discriminant validity was supported by weak-to-moderate correlations between the IMSF-FR and measures of sleepiness, propensity to sleep, and lapses of attention and memory. The IMSF-FR accurately distinguished cancer patients from healthy controls and was able to differentiate clinician rated levels of performance among cancer patients. The IMFS-FR is a reliable and valid tool to assess cancer-related fatigue. By providing integrated comprehensive characterization of fatigue, this instrument may assist clinicians implementing targeted interventions.

Addressing cancer-related fatigue through sleep: A secondary analysis of a randomized trial comparing acupuncture and cognitive behavioral therapy for insomnia

BackgroundFatigue is a troublesome symptom in cancer survivors that often results from disrupted sleep. We sought to assess whether two insomnia-focused non-pharmacological interventions are also effective for improving fatigue. MethodsWe analyzed data from a randomized clinical trial comparing cognitive behavioral therapy for insomnia (CBT-I) versus acupuncture for insomnia among cancer survivors. Participants were 109 patients who reported insomnia and moderate or worse fatigue. Interventions were delivered over eight weeks. Fatigue was evaluated at baseline, week 8, and week 20 using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). We used both mediation analysis and t-tests to explore the extent to which fatigue reduction was attributable to insomnia response. ResultsCompared to baseline, both CBT-I and acupuncture produced significant reductions in total MFSI-SF scores at week 8 (−17.1 points; 95% confidence interval [CI]: −21.1 to −13.1, and −13.2 points; 95% CI: -17.2 to -9.2, respectively, all p<0.001) and week 20 (-14.6 points; 95% CI: -18.6 to -10.6, and −14.2 points; 95% CI: -18.1 to -10.3. respectively, all p<0.001), with no significant between-group differences. MFSI-SF total scores at week 8 were significantly associated with sleep improvements in both CBT-I and acupuncture groups (p<0.001 and p=0.011, respectively). Insomnia responders demonstrated significantly greater improvements in mean MFSI-SF total scores compared with non-responders in the CBT-I group (p=0.016) but not in the acupuncture group. ConclusionCBT-I and acupuncture produced similar, clinically meaningful, and durable fatigue reductions in cancer survivors with insomnia, primarily through improvements in sleep. Acupuncture may also reduce fatigue through additional pathways. Trial registrationClinicalTrials.gov, identifier: NCT02356575

Explore the Application Value of Prospective Monitoring Model in the Nursing Management of Breast Cancer Patients During Perioperative Period.

PurposeTo explore the application value of prospective monitoring model in the nursing management of breast cancer patients during perioperative period.Methods300 perioperative breast cancer patients admitted to our hospital from January to August 2021 were randomly divided into the control group (n = 150) and the model group (n = 150). Both groups used routine nursing management, and the model group added nursing management based on a prospective monitoring model. The quality of surgical nursing, circumference of the upper limbs, and the scores of disability of arm-shoulder-hand (DASH), exerciseofself-care agencyscale (ESCA), social self-esteem scale (SSES), multidimensional fatigue symptom inventory-short form (MFSI-SF) and functional assessment of cancer therapy-breast cancer (FACT-B) were compared of the two groups.ResultsPostoperatively, the quality of surgical nursing was better in the model group than in the control group (P < 0.05). At 3 months postoperatively, the number of cases of upper limb lymphedema was higher in both groups than before (P < 0.05), but there was no statistical difference between the two groups in the preoperative and 3 months postoperative comparisons (P > 0.05). At 3 months postoperatively, the total DASH score was higher than preoperatively in both groups, but lower in the model group than in the control group (P < 0.05). After nursing, the ESCA and SSES scores of each dimension were higher in both groups than before, and the model group was higher than the control group (P < 0.05). At 3 months postoperatively, the total MFSI-SF score was lower than preoperatively in both groups, and lower in the model group than in the control group (P < 0.05). At 3 months postoperatively, the FACT-B scores of each dimensions were higher in the model group than in the control group (P < 0.05).ConclusionThe implementation of nursing management based on a prospective monitoring model for breast cancer patients during the perioperative period has important clinical value in improving the quality of surgical nursing and improving postoperative upper limb lymphedema, upper limb function, self-care ability, social self-esteem, cancer-related fatigue symptoms, quality of life, etc.

Acceptability, Compliance, and Safety of Non-small Cell Lung Cancer Cachectic Participants Continuing Compassionate Access in the ACCeRT Clinical Study

Objective: Cancer cachexia is defined as: a ‘multifactorial syndrome’, and it has been suggested that a multitargeted approach is required in its management. High prevalence is seen within non-small cell lung cancer, and patients may continue to experience cachexia post end of anti-cancer treatment, and in the late/end stage.Material and Methods: Participants who had completed week 20/End of Trial visit in the main Auckland’s Cancer Cachexia evaluating Resistance Training (ACCeRT) study were invited to continue with treatment under compassionate use. Participants could continue with 2.09 g of eicosapentaenoic acid (EPA), 300 mg COX-2 inhibitor (celecoxib), once daily; plus two sessions per week of progressive resistance training (PRT), and 20 g oral essential amino acids (EAA); high in leucine, in a split dose over three days post each session. Data was collected on the acceptability, compliance and adherence to medication/PRT sessions. Secondary endpoints included: change in body weight and fat free mass, handgrip and leg strength, the Functional Assessment of Anorexia/Cachexia Therapy, Multidimensional Fatigue Symptom Inventory-Short Form, World Health Organization Quality of Life — BREF, Glasgow prognostic score, and pro-inflammatory cytokines.Results: All six participants, who completed the main ACCeRT study, opted to continue with compassionate use. Acceptability remained high, with overall compliance to last study/PRT visit of 81.0% for EPA, 98.8% for celecoxib, 78.9% for PRT and 77.2% for EAA. Participants continued to lose body weight and Fat-Free Mass, along with reduced albumin and increased C-Reactive protein levels. Mean time on compassionate study treatment was 78 days, and with a mean overall survival of 257 days (140 + 117).Conclusion: Non-small cell lung cancer (NSCLC) cachectic patients are willing to be enrolled onto a multi-targeted treatment regimen, and may benefit from cachexia symptom management even during their late/refractory stage.

Chronic fatigue and physical distress influence the outcomes of immunotherapy treatment in patients with recurrent ovarian cancer

<h3>Objectives:</h3> <i>In vivo</i> preclinical studies have shown that chronic stress augments tumor proliferation and promotes an immunosuppressive tumor microenvironment through activation of beta-adrenergic receptor signaling. The deleterious effects of chronic stress and resulting fatigue on immune responses have also been well characterized in several disease entities, however the impact of these on response to immune check point blockade is still not known. Our objective was to investigate the relationship between the different dimensions of patient reported fatigue and distress on response to immune check point inhibitor (ICI) treatment in a cohort of women undergoing immunotherapy treatment for recurrent ovarian cancer. <h3>Methods:</h3> A single-arm phase 2 clinical trial (NCT02853318) was recently completed at our center on 40 patients with recurrent platinum-sensitive or platinum-resistant ovarian cancer using anti-PD1 pembrolizumab in combination with bevacizumab and oral cyclophosphamide, showing an overall response rate of 47.5% with a median progression free survival (PFS) of 10.0 months. A validated 30-item Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) was administered to all patients at baseline, after 3 months and 6 months of treatment, and at the time of disease progression to assess the multidimensional nature of fatigue and chronic stress (general, physical, emotional and mental fatigue, and vigor). Each subscale has a maximum score of 24 points to generate a total overall MFSI-SF score up to 96, whereby a higher score indicates greater exhaustion. Scores for each dimension as well as the composite scores were correlated with PFS using Pearson correlation. <h3>Results:</h3> The overall MFSI-SF fatigue score at baseline prior to starting ICI was 31.3 (n=40, SD ±10.8) and remained stable throughout the treatment until disease progression, indicating that the ICI combination treatment did not lead to increased fatigue in any dimensions. Patients who had shorter PFS (< 10 months) scored significantly higher on the physical (p=0.005) and overall fatigue measures (p=0.02) throughout the clinical trial compared to patients with durable clinical responses (PFS > 10 months), despite similar score on vigor subscales (p=0.9). There was no statistical difference in general, emotional and mental fatigue scores between patients with absent or abbreviated response to ICI, compared to patients with a durable clinical response. <h3>Conclusions:</h3> Patients experiencing greater chronic physical distress and chronic overall fatigue had poor response to an immune checkpoint inhibition combination with shorter PFS compared to the median among a cohort of women undergoing treatment for recurrent ovarian cancer. These findings further support the emerging evidence on the adverse effects of chronic fatigue and stress on beta-adrenergic signaling pathways, which may well modulate immunotherapy treatment responses.

Anamorelin combined with physical activity, and nutritional counseling for cancer-related fatigue: a preliminary study.

Cancer-related fatigue (CRF) is the most frequent and debilitating symptom in patients with advanced cancer. There are limited effective treatments for CRF. The objective of this prospective longitudinal study was to evaluate the change in CRF at Day 43 after treatment with combination therapy of oral Anamorelin 100mg daily with physical activity and nutrition counseling. In this study, patients with CRF [≤ 34 Functional Assessment of Chronic Illness Therapy-Fatigue subscales(FACIT-F)] received Anamorelin 100mg orally daily with standardized physical activity and nutrition counseling for 43days. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Anorexia Cachexia(FAACT-ACS), Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF), Patient-Reported Outcomes Measurement Information System(PROMIS-Fatigue), body composition, and physical performance tests were assessed at baseline, Day 15, 29, and 43. Frequency and type of side effects were determined by NCI CTAE 4.0.(NCT03035409). 28/45 (62%) of patients dosed were evaluable at Day 43. The mean, SD for FACIT-F subscale improvement from baseline was 4.89 (± 13.07), P = .058, MFSI-SF (G) - 3.46 (± 6.86), P = 0.013, PROMIS-fatigue - 4.14 (± 7.88), P = 0.010, FAACT ACS 3.48 (± 8.13), P = 0.035. Godin Liesure-Time physical activity questionnaire 7.41 (± 16.50), P = 0.038. Weight (kg) 1.81 (± 2.63), P = 0.005, and Lean Body Mass 1.54 (± 1.85), P = 0.001, IGF-1 36.50 (± 48.76), P = 0.015. There was no significant improvement in physical performance outcomes. No adverse events > grade 3 related to the study drug were reported. The use of the combination therapy was associated with improvement of CRF (FACIT-F fatigue, PROMIS-fatigue, MFSI-SF-general), activity (Godin-leisure time), anorexia (FAACT), body composition, and IGF-1 levels. Further studies using combination therapy for CRF are justified.

Actigraphy prior to Multiple Sleep Latency Test: nighttime total sleep time predicts sleep-onset latency.

To evaluate the clinical utility of actigraphy as compared with sleep questionnaires prior to the Multiple Sleep Latency Test (MSLT) in a sleep disorders clinic population. Twenty-eight clinically referred participants (mean age: 42.3 ± 18.8 years) completed the study protocol. On day 1, participants completed the following questionnaires: Epworth Sleepiness Scale (ESS), Insomnia Severity Index, Pittsburgh Sleep Quality Index (PSQI), Visual Analog Scale (affect, vigor), Patient Health Questionnaire, and Multidimensional Fatigue Symptom Inventory-Short Form. On days 1-8, participants wore an actigraph and completed a sleep diary to assess mean nighttime and mean daytime total sleep time and sleep efficiency or sleep percentage. On day 9, participants repeated the ESS and completed an MSLT. Correlations assessed mean MSLT sleep-onset latency (MSLT-SOL) vs actigraphy, sleep diary, and questionnaires. Chi-square analyses assessed abnormal MSLT-SOL (≤ 8 minutes) or daytime sleepiness (ESS ≥ 10) and referral question (ie, sleep-disordered breathing vs hypersomnolence disorder). Mean MSLT-SOL was correlated with nighttime total sleep time assessed via both actigraphy and diary, but not with questionnaires. Significant correlations emerged for ESS score on day 1 vs 9, actigraphy vs sleep diary mean nighttime total sleep time, and PSQI vs mean sleep diary sleep efficiency. There was no significant relationship between mean MSLT-SOL and referral question. Our finding that total sleep time measured by actigraphy was associated with MSLT-SOL suggests it is useful in informing the interpretation of MSLT findings; however, it does not appear to be a viable substitute for MSLT for the measurement of objective sleepiness in clinical settings. Kelly MR, Zeidler MR, DeCruz S, et al. Actigraphy prior to Multiple Sleep Latency Test: nighttime total sleep time predicts sleep-onset latency. J Clin Sleep Med. 2022;18(1):161-170.

Development of a patient reported outcome questionnaire to measure the impact of postpartum blood loss in women with moderate and severe anaemia: A study using a multi-faceted approach

Background: Globally, over one-third of pregnant women are anaemic and are at increased risk of postpartum haemorrhage (PPH). Tranexamic acid (TXA) given within 3 hours of birth significantly reduces death due to bleeding in women with PPH. However, for many, treatment is too late to prevent death from PPH. The WOMAN-2 trial aims to see if giving TXA can prevent PPH and other outcomes in women with moderate and severe anaemia. Assessing the impact of postpartum blood loss on women’s own perceptions of their health and well-being is an important outcome for the WOMAN-2 trial. This study aimed to develop a conceptual framework and questionnaire to measure the impact of postpartum blood loss on participant-reported outcomes (PRO) in women with moderate and severe anaemia. Methods: A conceptual framework and PRO questionnaire were developed using a multifaceted, iterative process. Factors influencing anaemic women’s postpartum experience were identified from review of the literature and through group discussion with them. De novo items were combined with those from an existing instrument (Multi-dimensional Fatigue Symptom Inventory, Short Form (MFSI-SF)). Content validity was tested among a group of obstetricians and anaemic postpartum women, revised and then pilot tested among 124 women with moderate and severe anaemia following vaginal birth. Results: Women with moderate and severe anaemia who experienced PPH reported more fatigue on the MFSI-SF (p=0.001); reported feeling more ill (p=0.004); and had greater difficulty breastfeeding (p=0.039), compared to those who did not experience PPH. Compared to women with moderate anaemia, women with severe anaemia reported experiencing worse symptoms of anaemia (p=0.001) and scored worse on the MFSI-SF (p=0.007). Conclusions: Significant differences between the scores of women who developed PPH and those who did not and the scores between women with moderate and severe anaemia indicate that the questionnaire had satisfactory construct validity.

Assessment of fatigue among aviation personnel involved in military flying in India employing Multidimensional Fatigue Symptom Inventory – Short Form (MFSI-SF)

Introduction: Fatigue has been recognized as a major safety hazard in modern aviation. There are numerous studies which have addressed various aspects such as the subjective symptoms, objective measures to diagnose fatigue, and its link with operator’s performance. This study was a novice attempt to assess the chronic fatigue among the aviation personnel employing “Multidimensional Fatigue Symptom Inventory – Short Form (MFSI-SF),” which is a well validated fatigue questionnaire. Material and Methods: A total of 93 aircrew and 30 ground crew of either sex from three military air bases were randomly selected for this cross-sectional observational study. The selected participants were requested to respond to 30 items listed in the survey form based on various types of symptoms along with severity that they experienced in the preceding 1 week. Results: The total fatigue score in case of the studied ground crew was higher than the studied aircrew group and this was statistically significant (P = 0.00001). The fighter, transport, and helicopter groups were not different from each other as far as their total fatigue score is concerned. However, ground crew group had significantly higher score in comparison to the score of the fighter, transport, and helicopter groups. In this study, 43.33% of ground crew participants and 11.82% of aircrew participants were observed to have fatigue. On stream-wise analysis, 2.94% of transport aircrew, 14.28% of fighter aircrew, 20.83% of helicopter aircrew, 52.17% Air Traffic Control (ATC) ground crew, and 14.28% of other ground crew who had participated in this study were fatigued. Conclusion: Fatigue in either form, i.e., acute or chronic, could affect both aircrew and ground crew. The present study had revealed that the proportion of ground crew suffering from chronic fatigue was more than the aircrew. The aircrew who were found to have such type of fatigue were younger in age and experience in comparison to their counterpart ground crew. Among the ground crew, a large percentage of ATC crew had this form of fatigue.

Effects of resistance exercise on complications, cancer-related fatigue and quality of life in nasopharyngeal carcinoma patients undergoing chemoradiotherapy: A randomised controlled trial.

Chemotherapy of nasopharyngeal carcinoma (NPC) can lead to significant side effects and complications. Exercises during chemoradiotherapy have potential to reduce complications and fatigue and improve quality of life. The aim of the randomised clinical study was to investigate the benefits of resistance exercise during chemoradiotherapy in NPC patients. A total of 146 patients were randomised to perform resistance or relaxation exercises during chemoradiotherapy. Resistance exercise consisted of eight machine-based progressive resistance exercises, and relaxation control consisted of progressive muscle relaxation. Side effects and complications were analysed, and fatigue was assessed by Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) scores. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ30) scale was used to evaluate the effects of resistance exercise or relaxation control on quality of life. Per-protocol analysis was performed on the collected data. Resistance exercise has stronger effects than relaxation in reducing complications, including oral mucositis, mouth-opening difficulties, xerostomia, hearing loss and nasal congestion, and alleviating both physical fatigue and mental fatigue. The improvement in quality of life was also more prominent among patients performing resistance exercise. For NPC patients undergoing chemoradiotherapy, resistance exercise has a better efficacy in reducing complications, alleviating fatigue and improving quality of life.

Association of mitochondrial DNA content and displacement loop region sequence variations with cancer-related fatigue in breast cancer survivors receiving chemotherapy

Cancer-related fatigue (CRF) is characterized by a lack of energy, and mitochondrial dysfunction is postulated to contribute to its etiology. This prospective cohort study assesses the self-reported fatigue levels of early-stage breast cancer patients using the validated Multi-Dimensional Fatigue Symptom Inventory–Short Form (MFSI-SF) and blood samples drawn at three time points: before treatment, approximately 6 weeks, and 12 weeks after the initiation of chemotherapy. The aim of this study is to evaluate mitochondrial measures with CRF, over the course of chemotherapy using mitochondrial DNA (mtDNA content) and displacement loop (D-loop) region sequence variations at nucleotide positions 303, 489 and 514. The relative mtDNA copy number was determined via real-time quantitative polymerase chain reaction and compared between study time points and D-loop sequence variants. The association of mtDNA content with MFSI-SF total and sub-domain scores was analyzed in a sample of 155 patients (mean age ± SD: 51.7 ± 8.8 years). The median mtDNA content decreased over 12 weeks after the initiation of chemotherapy (p < 0.001). Baseline mtDNA content was lower for nucleotide position 303 in sequence variations than for the reference sequence (67.2 copies vs 79.1 copies, p = 0.03). Physical fatigue negatively correlated with mtDNA content in both unadjusted (β = −0.0075, p = 0.048) and adjusted models (β = −0.0062, p = 0.042), accounting for age, anxiety, insomnia, haemoglobin levels and body mass index. Our findings add to the literature indicating that mitochondrial function serves as an important target for mitigating CRF.

1037 One Year Trajectory of Insomnia and Comorbid Symptoms in Women With Early Stage Breast Cancer

Abstract Introduction Insomnia symptoms are a common problem and are often comorbid with hot flashes, fatigue, anxiety, and depression following a breast cancer diagnosis. The present study examined changes in insomnia severity and comorbid symptoms in the year following diagnosis. Methods This study is part of a larger prospective observational cohort study of 100 women with early stage breast cancer. Insomnia symptoms were measured using the Insomnia Severity Index, fatigue was measured using the Multidimensional Fatigue Symptom Inventory-Short Form, anxiety and depression were assessed using the Hospital Anxiety and Depression Scale, and hot flashes were assessed using the Hot Flash Related Daily Interference Scale. Assessments were performed shortly after diagnosis, 4, 8, and 12 months. A series of repeated measures within subjects ANOVAs were performed to assess changes in symptoms over time. Results Among 100 women with breast cancer, 45% reported at least mild insomnia symptoms. There were significant quadratic effects of time on insomnia severity, F(3, 297)= 12.776, p ≤ .001, depression (F[3, 297]= 4.409, p = .005), and fatigue (F[3, 297]= 7.995, p ≤ .001). These symptoms initially worsen and then improve throughout the year, but they do not rebound to pre-treatment levels. Interference from hot flashes worsens and endures for longer than other symptoms but does begin to show improvement one year post-diagnosis (F[3, 297]= 12.110, p ≤ .001). The were no time effects for anxiety (F[3, 297] = 1.4, p = .243). Conclusion In general, women treated for breast cancer can expect insomnia and comorbid symptoms to worsen then improve, but not recover, during the first year after a breast cancer diagnosis. Early efforts to educate women and manage symptoms could prevent insomnia and other issues from becoming persistent problems. Support Dr. Garland is supported by a Scotiabank New Investigator Award and seed funding from the Beatrice Hunter Cancer Research Institute (BHCRI).

1031 Exploring the Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Daytime Productivity in Survivors of Breast Cancer

Abstract Introduction Post-treatment insomnia disorder and fatigue symptoms can impair work and daytime productivity in breast cancer survivors. Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improves insomnia and daytime fatigue. This feasibility study examined whether improving insomnia and fatigue using CBT-I is associated with improved work and activity productivity in breast cancer survivors. Methods 10 survivors of early stage breast cancer participated in 7 weekly individual CBT-I sessions. The primary outcome was the Work Productivity and Activity Impairment Questionnaire-General Health (WPAIQ-GH) questionnaire. Secondary outcomes were the Insomnia Severity Index (ISI) and the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). Assessments were conducted at baseline and post-treatment. Paired samples t-tests examined the impact of CBT-I on productivity and fatigue. Linear regression assessed whether change in fatigue was associated with change in productivity. Results Participants had a mean age of 50.8 (range 42-63) and the majority were diagnosed with stage II (60%) cancer. There was a significant reduction in fatigue [t(9)= 2.43, p =.04] and activity impairment due to insomnia [t(9)= 3.105, p &amp;lt;.05] following treatment. Insomnia affected 52% of work productivity at baseline with a non-significant decrease to 15% following treatment [t(3)= 2.25 p= .110]. Reductions in fatigue were significantly associated with reductions in activity impairment [F(1,8)= 7.25, p =.03], accounting for 47.5% of the variability. Conclusion Treating insomnia with CBT-I significantly improved daytime productivity, activity impairment, and fatigue. Controlled research with larger sample sizes is warranted to confirm these preliminary results. Support Nyissa Walsh is a trainee in the Cancer Research Training Program of the Beatrice Hunter Cancer Research Institute (BHCRI). Dr. Sheila Garland is supported by a Scotiabank New Investigator Award from BHCRI.

Cross-Sectional Associations of Fatigue Subtypes with Pain Interference in Younger, Middle-Aged, and Older Adults with Chronic Orofacial Pain.

Mental, emotional, physical, and general fatigue, as well as vigor, have each been associated with pain interference-defined as pain-related disruption of social, recreational, and work-related activities-in patients with chronic orofacial pain (COFP). The objectives of the current study were to compare levels of these fatigue subtypes across younger, middle-aged, and older patients with COFP and test the associations between fatigue subtypes and pain interference in these age groups. A cross-sectional cohort design was used. Participants self-reported fatigue subtypes (Multidimensional Fatigue Symptom Inventory-Short Form), pain interference (West Haven-Yale Multidimensional Pain Inventory), pain intensity (visual analog scale), pain duration (months), depression (Symptom Checklist 90-Revised), and sleep quality (Pittsburgh Sleep Quality Index) at their initial appointment at a tertiary orofacial pain clinic. Sixty younger (age 18-39), 134 middle-aged (age 40-59), and 51 older (age 60-79) COFP patients provided data for the study. Analysis of variance was used to compare levels of fatigue subtypes between the age groups. Regression with dummy-coding was used to test if the relationship between fatigue subtypes and pain interference varied by age. Older COFP patients reported less general fatigue and more vigor than younger or middle-aged adults. Fatigue subtypes were each associated with greater pain interference, but associations became nonsignificant after controlling for depression, sleep, and pain intensity/duration. Age group-by-fatigue subtype interactions were not observed. Managing fatigue may be important to reduce pain interference in COFP populations and may be accomplished in part by improving depression and sleep.

Establishing Reference Values for Health Related Quality of Life Scores During Pregnancy [16M

INTRODUCTION: This study aims to generate gestational-age specific Health-Related Quality of Life (HRQoL) scores from a diverse population of low-risk pregnant women, to provide reference values for future research and clinical practice. METHODS: We conducted a prospective longitudinal study at Mount Sinai Hospital in Toronto, Canada. Over a period of three months, we recruited 333 women over the age of 18 with low-risk singleton pregnancies between 12 and 40 weeks of gestation. Participants completed a demographic survey at the first visit and two HRQoL questionnaires - the Short Form-36 (SF-36) and the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) at each visit. The SF-36 was composed of eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional health, energy/fatigue, emotional well-being, social functioning, pain and general health scores. The MFSI-SF produced domains consisting of the general score and the vigor score. Gestational-age-specific mean HRQoL scores and standard deviations were calculated to determine how they changed throughout the course of pregnancy in various domains. Approved by Mount Sinai Hospital Research Ethics Board. RESULTS: Although SF36 scores were constant for the general domain, those for the energy domain as well as MFSI-SF scores tended to rise from 12 weeks and peak at 20-27 weeks before dropping slightly again and plateauing between 34 and 40 weeks. CONCLUSION: HRQoL scores, especially those related to energy and vigor, fluctuate during the course of pregnancy and these fluctuations need to be considered when comparing the effect of interventions or the progression of disease conditions during pregnancy.