5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment.

BACKGROUND: Cancer-related fatigue (CRF) is still undertreated in most patients, as evidence for pharmacological treatments is limited and conflicting. Also, the efficacy of the pharmacological agents relative to each other is still unclear. Therefore, medications that may potentially contribute to improving CRF will be investigated in this head-to-head trial. Our main objective is to compare the efficacy of methylphenidate vs. bupropion vs. ginseng vs. amantadine vs. placebo in patients with advanced cancer. METHODS: The 5-EPIFAT study is a 5-arm, randomized, multi-blind, placebo-controlled, multicenter trial that will use a parallel-group design with an equal allocation ratio comparing the efficacy and safety of four medications (Methylphenidate vs. Bupropion vs. Ginseng vs. Amantadine) versus placebo for management of CRF. We will recruit 255 adult patients with advanced cancer who experience fatigue intensity ≥ 4 based on a 0-10 scale. The study period includes a 4-week intervention and a 4-week follow-up with repeated measurements over time. The primary outcome is the cancer-related fatigue level over time, which will be measured by the functional assessment of chronic illness therapy-fatigue (FACIT-F) scale. To evaluate safety, the secondary outcome is the symptomatic adverse events, which will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events in cancer clinical trials (PRO-CTCAE). Also, a subgroup analysis based on a decision tree-based machine learning algorithm will be employed for the clinical prediction of different agents in homogeneous subgroups. DISCUSSION: The findings of the 5-EPIFAT trial could be helpful to guide clinical decision-making, personalization treatment approach, design of future trials, as well as the development of CRF management guidelines. TRIAL REGISTRATION: IRCT.ir IRCT20150302021307N6. Registered on 13 May 2023.

Perception of coronavirus disease (COVID-19) and its relationship with coping strategies and perceived social support in iranian people: a descriptive correlational study.

BACKGROUND: Perception of the threatening disease leads to coping behaviors that can affect the treatment process. Social support can be one of the factors influencing the perception of the disease and coping strategies. Our study aimed to determine the perception of the disease, its relationship with coping strategies and social support in COVID-19 patients in Iran. METHODS: This cross-sectional study was conducted on 1014 patients who were hospitalized during October 2020 to May 2021 through multi-stage sampling method. The data-gathering instruments consisted a demographic information checklist, and standard questionnaires including disease perception, social support, and coping strategies. Correlation coefficient, multiple linear regression model, and simple linear regression model were used for data analysis. RESULTS: The mean age of the participants was 40.87 ± 12.42 and the majority of them were female (67.2%(, married (60.1%), and had relatives who had COVID-19 (82.6%). There was a significant inverse relationship between variables (identity, outcomes, emotional expressions etc.) and social support (> 0.01). Also there was a significant direct relationship between variables (self-control, therapeutic susceptibility etc.) and the coping behavior (p < 0.05). There was an inverse relationship between the variables (outcomes, self-blaming, sex, etc.) (P = 0.0001) and a direct one between the variables (education, disease phase, etc.) and perceived social support (P = 0.004). CONCLUSIONS: These results show the importance of promoting positive coping strategies and social support in the face of large-scale health crises. The knowledge of nurses about the results of this study, who are responsible for the care and education of the patient, can be effective in the length of hospitalization and reducing costs.

Role of self-management program based on 5A nursing model in quality of life among patients undergoing hemodialysis: a Randomized Clinical Trial.

INTRODUCTION: Various nursing models are usually employed to achieve self-management and improve the quality of life in chronic conditions. Given its person-based characteristics, the 5 A nursing model can improve the quality of life of hemodialysis patients. PURPOSE: This study aimed to determine the role of a self-management program based on the 5 A nursing model in the quality of life of patients undergoing hemodialysis. MATERIALS AND METHODS: This clinical trial was conducted on hemodialysis patients in Iran. Random sampling was adopted to assign 60 patients to intervention and control groups. After the participants completed a demographic questionnaire and the Kidney Disease Quality of Life-Short Form (KDQOL-SF), routine measures were taken in the control group. However, the 5 A nursing model was implemented in the intervention group for three months. The self-care program was executed in face-to-face sessions or via phone calls and SMSs. After three months, the quality of life was measured again in both groups. FINDINGS: There were significant differences after the intervention between the intervention and control groups in specific dimensions of quality of life, such as cognitive functions, symptoms, sleep, dialysis, social support, and renal complications (P < 0.05). The two groups also had significant differences in the general scores of quality of life (P < 0.05). CONCLUSION: The 5 A self-management intervention as a person-based model could improve self-care in hemodialysis patients. Nurses can implement this model to mitigate care costs, enhance interventions, and improve patients' quality of life. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT20211103052955N1; 19/11/2021).

Determining massage dose-response to improve cancer-related symptom cluster of pain, fatigue, and sleep disturbance: A 7-arm randomized trial in palliative cancer care.

BACKGROUND: The efficacy of various massage doses in palliative cancer care settings is still debated, and no specific protocol is available. AIM: Evaluating response to various massage doses for symptom cluster of pain-fatigue-sleep. DESIGN: A 7-arm randomized-controlled trial with weekly massage for 4 weeks depending on the prescribed dose (15-, 30-, or 60-min; 2× or 3×/week) and a 4-week follow-up. The intensities of pain, fatigue, and sleep disturbance were measured using a 0-10 scale at nine-timepoint; baseline, weekly during the intervention, and the follow-up period. Then, the mean scores of the three symptoms were calculated as the symptom cluster intensity at each timepoint. IRCT.ir IRCT20150302021307N5. SETTING/PARTICIPANTS: Adults with cancer (n = 273) who reported all three symptoms at three oncology centers in Iran. RESULTS: The odds of clinical improvement (at least 30% reduction in symptom cluster intensity from baseline) increased with dose-escalation significantly [(OR = 17.37; 95% CI = 3.87-77.90 for 60-min doses); (OR = 11.71; 95% CI = 2.60-52.69, for 30-min doses); (OR = 4.36; 95% CI = 0.94-20.32, for 15-min doses)]. The effect durability was significantly shorter at 15-min doses compared to 30- and 60-min doses. The odds of improvement for doses 3×/week was not significant compared to doses 2×/week (OR = 12.27 vs OR = 8.34); however, the effect durability for doses 3×/week was significantly higher. CONCLUSIONS: The findings indicated that dose-escalation increases the efficacy of massage for the pain-fatigue-sleep symptom cluster. Although the 60-min doses were found to be more effective, the 30-min doses can be considered more practical because they are less costly and time-consuming. Our findings can be helpful to develop massage guidelines in palliative care settings. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20150302021307N5.

A randomized trial of comparing video telecare education vs. in-person education on dietary regimen compliance in patients with type 2 diabetes mellitus: a support for clinical telehealth Providers.

BACKGROUND: Compliance to dietary recommendations by patients is the most difficult part of diabetes management. The nature of any educational method is to increase patients' awareness. But the question is, what is the effect of each method and for this purpose a comparative method should be considered. Therefore, this study was conducted to compare the effects of in-person education versus video tele-education on dietary regimen compliance in patients with T2DM. METHODS: In this trial, 378 patients with type 2 diabetes mellitus (T2DM) were random allocated into video tele-education, in-person education and control groups. The patients' weight and biochemical parameters were measured before educational programs and three-month later. RESULTS: The mean changes of patients' weight, glycemic parameters, and Lipid profiles decreased more in the two educational groups than the control group in a three-month period. There were no significant differences in the all study variables between the in-person and video education groups in post interventions except Total Cholesterol (TC). The pre- and post-intervention changes in the weight, TC, hemoglobin A1c, Triglyceride, and Very Low-density Lipoprotein Cholesterol were significant in both in-person group and video group. None of the educational programs had a significant impact on the Fasting blood sugar, Low-Density Lipoprotein Cholesterol, and High-Density Lipoprotein Cholesterol. DISCUSSION: Video tele-education was just as effective as in-person educational method on dietary regimen compliance among patients with T2DM in a three-month period. Therefore, it is recommended to use video tele-education in combination with or as an alternative to the in-person education method. This study provides support for diabetes educator. TRIAL REGISTRATION: This investigation was registered in the Iranian Registry of Clinical Trials Center ( IRCT20150302021307N4 ).

Prevalence of Substance Use among Psychotic Patients and Determining Its Strongest Predictor.

Objective: Although comorbidity of psychotic disorders and substance use can lead to increase in mortality, less is known about the outbreak and predictors. Psychotic patients tend to be overlooked during assessment; hence, the possibility of an undertreated or missed condition such as increasing substance use. This investigation aimed to measure the prevalence of substance use in psychotic patients and to survey the powerful predictors. Method : In a 1-year cross-sectional study, 311 psychotic patients were assessed using the Structured Interview Based on DSM-5 for diagnostic confirmation as well as questions surveying prevalence and possible predictors of substance use. Results: Prevalence of substance use among psychotic patients was 37.9%. Several variables were identified as factors associated with drug abuse among the psychotic patients. These included male gender, younger age, being currently homeless, a history of imprisonment, and having family history of drug use. The strongest predictors of substance use, however, were family history of drug use, male gender, and being currently homelessness. Conclusion: Policymakers should note the importance of substance use among psychotic patients. Developing active screening strategies and comprehensive preventive plans, especially in the high-risk population, is suggested.

Slow-Stroke Back Massage Compared With Music Therapy for Leukemia-Related Pain and Fatigue: A Randomized Controlled Trial.

PURPOSE: Comparison of two safe complementary medicine methods to treat cancer-related pain and fatigue in adult patients with acute leukemia during active treatment with chemotherapy. METHODS: A randomized trial with three groups (light massage, music therapy, and standard care) in Ahvaz, Iran, between 2018 and 2019. A total of 104 participants of the massage and music therapy groups received 15-minute intervention sessions, thrice weekly for 4 weeks, and participants of the control group received standard care. Cancer-related pain and fatigue intensity were measured by numeric self-report rating scales. During the 4 weeks of the interventions, pain and fatigue intensity were measured weekly. All the groups were followed up for 2 weeks after the end of the intervention. RESULTS: Pain and fatigue intensity decreased significantly over time between the intervention groups compared with the standard care group. In the massage and music therapy groups, a progressive reduction of pain and fatigue intensity over time (from the baseline to the fourth week) was observed. Fatigue intensity did not differ between the two intervention groups. Pain intensity decreased more in the massage group compared with the music therapy group. The durable effects of the massage therapy were greater compared with the music therapy 2 weeks after the intervention was completed. CONCLUSION: Light massage was more effective and persisted longer than the music therapy for controlling leukemia-related pain and fatigue in adult patients with acute leukemia.

The challenge of deciding between home-discharge versus hospitalization in COVID-19 patients: The role of initial imaging and clinicolaboratory data.

BACKGROUND/OBJECTIVE: It is important to predict the COVID-19 patient's prognosis, particularly in countries with lack or deficiency of medical resource for patient's triage management. Currently, WHO guideline suggests using chest imaging in addition to clinicolaboratory evaluation to decide on triage between home-discharge versus hospitalization. We designed our study to validate this recommendation to guide clinicians. This study providing some suggestions to guide clinicians for better decision making in 2020. METHODS: In this retrospective study, patients with RT-PCR confirmed COVID-19 (N = 213) were divided in different clinical and management scenarios: home-discharge, ward hospitalization and ICU admission. We reviewed the patient's initial chest CT if available. We evaluated quantitative and qualitative characteristics of CT as well as relevant available clinicolaboratory data. Chi-square, One-Way ANOVA and Paired t-test were used for analysis. RESULTS: The finding showed that most patients with mixed patterns, pleural effusion, 5 lobes involved, total score ≥10, SpO2% ≤ 90, ESR (mm/h) ≥ 60 and WBC (103/µL) ≥ 8000 were hospitalized. Most patients with Ground-glass opacities only, ≤3 lobes involvement, peripheral distribution, SpO2% ≥ 95, ESR (mm/h) < 30 and WBC(103/µL) < 6000 were home-discharged. CONCLUSIONS: This study suggests the use of initial chest CT (qualitative and quantitative evaluation) in addition to initial clinicolaboratory data could be a useful supplementary method for clinical management and it is an excellent decision making tool (home-discharge versus ICU/Ward admission) for clinicians.

The relationship between pain, fatigue, sleep disorders and quality of life in adult patients with acute leukaemia: During the first year after diagnosis.

The aim of this study was to investigate the relationship between pain, fatigue, sleep disorders and quality of life and assess the most powerful predictor of quality of life in patients with acute leukaemia. In this cross-sectional multicentre study, 406 patients were recruited. Data were collected using the Iranian Short-Form 36-item Health Survey, the Pittsburgh Sleep Quality Index, and the Numeric Rating Scale for Pain and Fatigue Intensity. It was found that pain and fatigue had direct relationship with sleep disorders. Statistically significant relationships were reported between pain, fatigue, sleep disorders and QoL. Also, a statistically significant relationship was found between pain and QoL (p < .001). Pain, fatigue and sleep disorders in total had the predictive power for quality of life (R2  = 36%). The most powerful predictor of quality of life was pain. It is suggested that healthcare professionals note the importance of patients' symptoms in clinical investigations and take appropriate measures for their management. The assessment of pain as the most powerful predictor of quality of life can be considered a basis for the improvement of quality of life, fatigue and sleep quality in patients with acute leukaemia.

The effects of setarud on the immunological status of HIV-positive patients: Efficacy of a novel multi-herbal drug.

OBJECTIVE: This study examines the effect of the addition of IMOD, a novel multi-herbal drug to the highly active anti-retroviral therapy (HAART) regimen, on the immunological status of HIV-positive patients. MATERIALS AND METHODS: A randomized two-parallel-group (HAART group versus HAART+IMOD group), pretest-posttest design was used.Sixty patients with indications for treatment with the HAART regimen participated. One week before and 2 days after the treatments, immunological parameters including total lymphocyte count (TLC) and CD4 cell count were assessed.The intervention group received the HAART regimen plus IMOD every day for 3 months. The control group received only the HAART regimen every day for 3 months. RESULTS: In the intervention group, a significant difference was observed in CD4between before and after drug therapy (CD4 was increased). However, in the control group, the difference in CD4 was not significant before and after drug therapy. The difference in TLC was not significantly different between the two groups before and after therapy. Nevertheless, TLC was higher in the intervention group. CONCLUSION: IMOD (as a herbal drug) has been successfully added to the HAART regimen to improve the immunological status of HIV-positive patients.

Effects of Slow-Stroke Back Massage on Symptom Cluster in Adult Patients With Acute Leukemia: Supportive Care in Cancer Nursing.

BACKGROUND: Patients with acute leukemia usually experience pain, fatigue, and sleep disorders, which affect their quality of life. Massage therapy, as a nondrug approach, can be useful in controlling such problems. However, very few studies have been conducted on the effects of massage therapy on the complications of leukemia. OBJECTIVE: The aim of this study was to examine the effects of slow-stroke back massage (SSBM) on the symptom cluster in acute leukemia adult patients undergoing chemotherapy. METHODS: In this randomized controlled trial, 60 patients with acute leukemia were allocated randomly to either the intervention or control group. The intervention group received SSBM 3 times a week (every other day for 10 minutes) for 4 weeks. The pain, fatigue, and sleep disorder intensities were measured using the numeric rating scale. The sleep quality was measured using the Pittsburgh Sleep Quality Index. Statistical tests of χ, t test, and the repeated-measure analysis of variance were used for data analysis. RESULTS: Results showed that the SSBM intervention significantly reduced the progressive sleep disorder, pain, fatigue, and improved sleep quality over time. CONCLUSIONS: Slow-stroke back massage, as a simple, noninvasive, and cost-effective approach, along with routine nursing care, can be used to improve the symptom cluster of pain, fatigue, and sleep disorders in leukemia patients. IMPLICATIONS FOR PRACTICE: Oncology nurses can increase their knowledge regarding this symptom cluster and work to diminish the cluster components by using SSBM in adult leukemia patients.