scholarly journals Effect of Wellness Education on Quality of Life of Patients With Non–Small Cell Lung Cancer Treated With First-Line Icotinib and on Their Family Caregivers

2019 ◽  
Vol 18 ◽  
pp. 153473541984237 ◽  
Author(s):  
Yanwei Li ◽  
Li Ling ◽  
Pan Zhanyu
Keyword(s):  
Quality Of Life ◽  
Family Environment ◽  
Controlled Trial ◽  
Depression Scale ◽  
Well Being ◽  
Control Group ◽  
Education Intervention ◽  
Education Group ◽  
Wellness Education

Objective: To examine the effects of a wellness-education intervention on quality of life (QOL) of patients with NSCLC treated with icotinib and on their caregivers. Methods: This feasibility study was a prospective pilot randomized controlled trial to evaluate a wellness-education intervention in NSCLC patients and caregivers undergoing icotinib treatment. The participants in the wellness-education group were provided with well-being information over 8 weeks. The Family Environment Scale (FES), Functional Assessment of Cancer Therapy–Lung (FACT-L), Caregiver QOL Index–Cancer Scale (CQOLC), and Hospital Anxiety and Depression Scale (HADS) were measured at baseline prior to randomization and after 8 weeks. Patients completed the FACT-L and HADS, caregivers completed the CQOLC and FES. Results: 67 patients/caregivers in the wellness-education group and 71 in the control group could be analyzed. Feasibility targets were the following: (1) >70% study enrollment of eligible patients; (2) >90% of participants completing this study; (3) <10% missing data. Wellness-education group had better change scores at 8 weeks for the emotional well-being subscale of FACT-L (12.8 vs 15.6, P = .014), anxiety subscale of HADS (6.1 vs 6.7, P = .030), adaptation (66.0 vs 54.7, P = .037) and financial subscales of CQOLC (70.8 vs 69.8, P = .044), and the cohesion (7.3 ± 1.8 vs 5.7 ± 1.7, P= .021) and conflict (3.4 ± 1.9 vs 4.5 ± 1.7, P = .031) subscales of the FES. Conclusion: Wellness-education in patients/caregivers with NSCLC treated with icotinib are feasible and could improve patients’ QOL and their relationship with caregivers.

A Proposal of an innovative program for informal caregivers of patients with mood disorders

2017 ◽  
Vol 41 (S1) ◽  
pp. S603-S603
Author(s):  
J. Cabral ◽  
C. Barreto Carvalho ◽  
P. Castilho Freitas ◽  
C. Pato
Keyword(s):  
Quality Of Life ◽  
Mood Disorders ◽  
Negative Impact ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
Well Being ◽  
Control Group ◽  
Compassion Focused Therapy ◽  
The Impact

IntroductionIntervention with informal caregivers (IC) of psychiatric patients is internationally recognized as relevant and a priority. However, the existing responses in this area are still insufficient, especially regarding caregivers of individuals with mood disorders (MD). Mindfulness and compassion focused therapy have proven to be an effective approach in stress reduction and in improving emotional and social well-being of caregivers of patients with other conditions. However, no studies testing these new approaches in IC of patients with MD have been carried out. The objective of this work is to present a research project that aims to develop, implement and empirically test the effectiveness of an innovative group program to help informal caregivers of individuals with mood disorders to cope with the negative impact of the disease and reduce caregiver burdens.MethodsThe design of this experimental study to test the program's efficacy is a non-randomised controlled trial (nrct) with 12 months follow-up, with a mixed assessment methodology (quantitative and qualitative analysis). A sample of 60 informal caregivers of individuals with chronic MD will be constituted (n = 30 Control group; n= 30 Experimental group).ResultsWe expect the program to promote significant changes in participants in terms of several emotional variables (eg: burden, stress, resilience, compassion and quality of life).ConclusionsFurther efforts to continue studying the impact of interventions in caregivers should be carried out, as a way to improve the quality of life of caregivers and their ability to provide informal care to MD patients.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Kathleen P. O'Hora ◽  
Raquel A. Osorno ◽  
Dena Sadeghi-Bahmani ◽  
Mateo Lopez ◽  
Allison Morehouse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Early Treatment ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact ◽  
Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

A placebo-controlled trial of Sertraline's effects on symptoms, well-being and survival in advanced cancer: The ZEST Trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9002-9002 ◽  
Author(s):  
N. R. Wilcken ◽  
D. Goldstein ◽  
A. K. Nowak ◽  
P. J. Beale ◽  
M. Jefford ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Advanced Cancer ◽  
Cox Model ◽  
Controlled Trial ◽  
Depression Scale ◽  
Final Analysis ◽  
Well Being ◽  
Hazard Ratio ◽  
Sensitivity Analyses

9002 Background: Depression, anxiety, fatigue and impaired well-being are common, important and closely related in advanced cancer. We sought to determine the effects of sertraline (a well-tolerated, SSRI antidepressant) on these symptoms and survival in a broad cross-section of people with advanced cancer but without major depression. Methods: 189 participants (pts) were randomly allocated to sertraline 50 mg daily or placebo. Assessments were at baseline; months 1, 2, 4, 6, 9, 12; and, then 3-monthly. Outcome measures rated by pts included the: Centre for Epidemiologic Studies Depression scale (CES-D); Hospital Anxiety and Depression Scale (HADS-A, HADS-D); and the Functional Assessment of Cancer Therapy General and Fatigue scales (FACT-G and FACT-F). Clinicians completed Spitzer's Quality of Life Index (SQLI). Outcomes on all scales are expressed from 0 (worst) to 100 (best). The primary analyses of sertraline's effects on quality of life were based on scores at 4 and 8 weeks adjusted for baseline scores using generalised estimating equations. Efficacy analyses are by intention to treat; toxicity analyses by treatment received. P-values and 95% confidence intervals (CI) are 2-sided. Results: Recruitment was stopped after the first planned interim analysis of 150 pts showed a trend in overall survival favouring placebo (univariable logrank p=0.04; multivariable Cox model hazard ratio 1.61, CI 1.1 to 2.5, p=0.02). This trend was weaker at the final analysis including all 189 patients and longer follow-up (univariable logrank p=0.09); and, after accounting for baseline factors (multivariable Cox model hazard ratio 1.27, CI 0.87 to 1.8, p=0.2). Sertraline had no significant effects (scale: benefit over placebo, 95% CI) on depression (CES-D: 0.4, −2.6 to 3.4), anxiety (HADS-A: 2.0, −1.5 to 5.5), fatigue (FACT-F: 0.3, −4.3 to 4.9), overall quality of life (FACT-G: 1.7, −1.3 to 4.7) or clinicians’ ratings (SQLI: 2.0, −2.5 to 6.5). Subgroup and sensitivity analyses also excluded significant benefits. Sertraline was discontinued more often and earlier than placebo (logrank p = 0.03). The trial was closed for lack of benefit. Conclusions: Sertraline did not improve symptoms, well-being or survival and should be reserved for those with a proven indication. No significant financial relationships to disclose.

AwareCare: a pilot randomized controlled trial of an awareness-based staff training intervention to improve quality of life for residents with severe dementia in long-term care settings

2012 ◽  
Vol 25 (1) ◽  
pp. 128-139 ◽  
Author(s):  
Linda Clare ◽  
Rhiannon Whitaker ◽  
Robert T Woods ◽  
Catherine Quinn ◽  
Hannah Jelley ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Care Home ◽  
Intervention Group ◽  
Well Being ◽  
Care Staff ◽  
Control Group ◽  
Severe Dementia ◽  
Term Care

ABSTRACTBackground: The extent to which care home residents with severe dementia show awareness is influenced by the extent to which the environment provides opportunities for engagement and by the way in which care staff interact with them. We aimed to establish whether training care staff to observe and identify signs of awareness in residents with severe dementia resulted in improved quality of life for residents.Methods: In this pilot cluster randomized trial, care staff in four homes (n = 32) received training and supervision and carried out structured observations of residents using the AwareCare measure (n = 32) over an eight-week period, while staff in four control homes (n = 33) had no training with regard to their residents (n = 33) and no contact with the research team. The primary outcome was resident quality of life. Secondary outcomes were resident well-being, behavior and cognition, staff attitudes and well-being, and care practices in the home.Results: Following intervention, residents in the intervention group had significantly better quality of life as rated by family members than those in the control group, but care staff ratings of quality of life did not differ. There were no other significant between-group differences. Staff participating in the intervention identified benefits in terms of their understanding of residents’ needs.Conclusions: Staff were able to use the observational measure effectively and relatives of residents in the intervention homes perceived an improvement in their quality of life.

scholarly journals Virtual reality for relatives of ICU patients to improve psychological sequelae: study protocol for a multicentre, randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e049704
Author(s):  
Johan H Vlake ◽  
Jasper van Bommel ◽  
Evert-Jan Wils ◽  
Tim Korevaar ◽  
Merel E Hellemons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Virtual Reality ◽  
Intensive Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Icu Patients ◽  
Randomised Controlled

IntroductionIntensive care unit (ICU) admission of a relative might lead to psychological distress and complicated grief (post-intensive care syndrome–family; PICS-F). Evidence suggests that increased distress during ICU stay increases risk of PICS-F, resulting in difficulty returning to their normal lives after the ICU experience. Effective interventions to improve PICS-F are currently lacking. In the present trial, we hypothesised that information provision using ICU-specific Virtual Reality for Family members/relatives (ICU-VR-F) may improve understanding of the ICU and subsequently improve psychological well-being and quality of life in relatives of patients admitted to the ICU.Methods and analysisThis multicentre, clustered randomised controlled trial will be conducted from January to December 2021 in the mixed medical-surgical ICUs of four hospitals in Rotterdam, the Netherlands. We aim to include adult relatives of 160 ICU patients with an expected ICU length of stay over 72 hours. Participants will be randomised clustered per patient in a 1:1 ratio to either the intervention or control group. Participants allocated to the intervention group will receive ICU-VR-F, an information video that can be watched in VR, while the control group will receive usual care. Initiation of ICU-VR-F will be during their hospital visit unless participants cannot visit the hospital due to COVID-19 regulations, then VR can be watched digitally at home. The primary objective is to study the effect of ICU-VR-F on psychological well-being and quality of life up to 6 months after the patients’ ICU discharge. The secondary outcome is the degree of understanding of ICU treatment and ICU modalities.Ethics and disseminationThe Medical Ethics Committee of the Erasmus Medical Centre, Rotterdam, the Netherlands, approved the study and local approval was obtained from each participating centre (NL73670.078.20). Our findings will be disseminated by presentation of the results at (inter)national conferences and publication in scientific, peer-reviewed journals.Trial registration numberNetherlands Trial Register (TrialRegister.nl, NL9220).

scholarly journals Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo)

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Marjolein M. Iversen ◽  
Jannicke Igland ◽  
Hilde Smith-Strøm ◽  
Truls Østbye ◽  
Grethe S. Tell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Foot Ulcer ◽  
Well Being ◽  
Foot Ulcers ◽  
Control Group ◽  
Patient Reported ◽  
Reported Health

Abstract Background Follow-up care provided via telemedicine (TM) is intended to be a more integrated care pathway to manage diabetes-related foot ulcers (DFU) than traditionally-delivered healthcare. However, knowledge of the effect of TM follow-up on PROMs including self-reported health, well-being and QOL in patients with DFUs is lacking and often neglected in RCT reports in general. Therefore, in this study of secondary outcomes from the DiaFOTo trial, the aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care. Methods The current study reports secondary endpoints from a cluster randomized controlled trial whose primary endpoint was ulcer healing time. The trial included 182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway. Mean (SD) diabetes duration for the study population was 20.8 (15.0). The intervention group received care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention. The intervention included an interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care. In total 156 participants (78/78) reported on secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer–Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects regression was used to investigate possible differences in changes in the scores between the intervention and control group at the end of follow-up. Results In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life. Conclusions There were no significant differences in changes in scores for the patient reported outcomes between the intervention and control group, indicating that the intervention did not affect the participants’ health, well-being and quality of life. Trial registration Clinicaltrials.gov, NCT01710774. Registered October 19th, 2012.

scholarly journals Effect of hope therapy on psychological well-being of women after abortion: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Fatemeh Raphi ◽  
Soheila Bani ◽  
Mahmoud Farvareshi ◽  
Shirin Hasanpour ◽  
Mojgan Mirghafourvand
Keyword(s):  
Quality Of Life ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Psychological Well Being ◽  
Counseling Group ◽  
The Mean ◽  
Hope Therapy

Abstract Background Giving a healthy birth plays a vital role in a person’s personality development, but giving unhealthy birth and abortion can increase the risk of a range of mental disorders and psychological harms including reduced well-being and quality of life. Psychological interventions can reduce the problems of individuals, so the present study was conducted to evaluate the effect of counseling with hope therapy on psychological well-being (primary outcome) and quality of life (secondary outcome) of women with an experience of abortion. Method This randomized controlled trial was conducted in Alzahra and Taleghani educational and medical centers in Tabriz, Iran, on 52 women aged 16 years and above whose pregnancies led to abortion in 2020–21. Participants were assigned to intervention and control groups using random blocking method. The intervention group received counseling with hope therapy approach in 8 sessions of 45 min twice a week. The psychological well-being and WHO Quality of Life (WHOQOL) questionnaires were completed before the intervention and immediately and 4 weeks after the intervention. Independent t-test and repeated measures ANOVA were used to compare the outcomes in two groups. Results After the intervention based on the repeated measures ANOVA test and by adjusting the baseline score, the mean total score of psychological well-being in the counseling group was significantly higher than that in the control group (adjusted mean difference (AMD): 76.76; 95% confidence interval (95% CI): 63.81 to 89.70; P < 0.001). Also, the mean total score of quality of life in the counseling group was significantly higher than in the control group (AMD: 7.93; 95% CI: 6.38 to 9.46; P < 0.001). The mean score of all sub-domains of psychological well-being and quality of life in the counseling group was significantly higher than that in the control group (P < 0.05). Conclusion Using hope therapy can improve the psychological well-being and quality of life of women after abortion. However, further clinical trials are required before making a definitive conclusion. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N60. Date of registration: 17 Dec 2020. Date of first registration: 20 Dec 2020.

scholarly journals Psycho-emotional profile of patients with vulvar lichen sclerosus

2020 ◽  
Vol 14 (2) ◽  
pp. 203-210
Author(s):  
A. G. Solopova ◽  
E. E. Achkasov ◽  
A. D. Makatsariya ◽  
V. S. Moskvichyova ◽  
A. E. Ivanov
Keyword(s):  
Quality Of Life ◽  
Depressive Disorders ◽  
Life Quality ◽  
Depression Scale ◽  
Lichen Sclerosus ◽  
Well Being ◽  
Control Group ◽  
Significant Deterioration ◽  
Vulvar Lichen Sclerosus

Aim: to assess the psycho-emotional profile in patients with vulvar lichen sclerosus.Materials and methods. We examined 57 patients with a diagnosis of vulvar lichen sclerosus, the average age of 35.0 ± 0.6 (from 18 to 45) years. The control group included 45 healthy women without dystrophic changes in the external genital organs, who applied for a routine examination. The following methods were used to analyze the psycho-emotional profile: WAM questionnaire (well-being, activity, mood), Hospital Anxiety and Depression Scale (HADS), the Dermatology Life Quality Index (DLQI).Results. In patients with vulvar lichen sclerosus a decrease in indicators “well-being” (24.3 ± 1.7 versus 52.4 ± 5.6 scores) and “mood” (28.7 ± 3.6 versus 58.1 ± 6.1 scores) was revealed; “activity” was changed slightly (41.2 ± 3.2 against 47.4 ± 4.9 scores). Depressive (75.4 % versus 15.6 %) and anxiety (68.4 % versus 20 %) disorders were also more common in this group. Significant deterioration in the quality of life in patients was confirmed by a DIQL (18.79 ± 4.98 scores).Conclusion. Psycho-emotional profile of patients with vulvar lichen sclerosus is characterized by a change in most of the analyzed parameters. The presence of anxiety-depressive disorders can aggravate both the general somatic state and the course of the underlying disease. So activities aimed at improving the quality of life should be included in the rehabilitation of these patients.

scholarly journals An assisted structured reflection on life events and life goals in advanced cancer patients: Outcomes of a randomized controlled trial (Life InSight Application (LISA) study)

2018 ◽  
Vol 33 (2) ◽  
pp. 221-231
Author(s):  
Renske Kruizinga ◽  
Michael Scherer-Rath ◽  
Johannes BAM Schilderman ◽  
Iris D Hartog ◽  
Jacoba PM Van Der Loos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Life Goals ◽  
Control Group ◽  
Incurable Cancer ◽  
Randomized Controlled ◽  
Spiritual Well Being

Background: Diagnosis and treatment of incurable cancer as a life-changing experience evokes difficult existential questions. Aim: A structured reflection could improve patients’ quality of life and spiritual well-being. We developed an interview model on life events and ultimate life goals and performed a randomized controlled trial to evaluate the effect thereof on quality of life and spiritual well-being. Design: The intervention group had two consultations with a spiritual counselor. The control group received care as usual. EORTC QLQ-C15-PAL and the FACIT-sp were administered at baseline and 2 and 4 months after baseline. Linear mixed model analysis was performed to test between-group differences over time. Participants: Adult patients with incurable cancer and a life expectancy ⩾6 months were randomized in a 1:1 ratio to the intervention or control group. Results: A total of 153 patients from six different hospitals were included: 77 in the intervention group and 76 in the control group. Quality of life and spiritual well-being did not significantly change over time between groups. The experience of Meaning/Peace was found to significantly influence quality of life ( β = 0.52, adj. R2 = 0.26) and satisfaction with life ( β = 0.61, adj. R2 = 0.37). Conclusion: Although our newly developed interview model was well perceived by patients, we were not able to demonstrate a significant difference in quality of life and spiritual well-being between groups. Future interventions by spiritual counselors aimed at improving quality of life, and spiritual well-being should focus on the provision of sources of meaning and peace.

Comparing counseling and dignity therapies in home care patients: A pilot study

2015 ◽  
Vol 14 (4) ◽  
pp. 321-329 ◽  
Author(s):  
David Rudilla ◽  
Laura Galiana ◽  
Amparo Oliver ◽  
Pilar Barreto
Keyword(s):  
Quality Of Life ◽  
Home Care ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Depression Scale ◽  
Well Being ◽  
University Hospital ◽  
Dignity Therapy ◽  
Counseling Group

AbstractObjective:Several studies have successfully tested psychosocial interventions in palliative care patients. Counseling is the technique most often employed. Dignity therapy (DT) has recently emerged as a tool that can be utilized to address patients' needs at the end of life. The aims of our study were to examine the effects of DT and counseling and to offer useful information that could be put into practice to better meet patients' needs.Method:We developed a pilot randomized controlled trial at the Home Care Unit of the General University Hospital of Valencia (Spain). Some 70 patients were assigned to two therapy groups. The measurement instruments employed included the Patient Dignity Inventory (PDI), the Hospital Anxiety and Depression Scale (HADS), the Brief Resilient Coping Scale (BRCS), the GES Questionnaire, the Duke–UNC-11 Functional Social Support Questionnaire, and two items from the EORTC Quality of Life C30 Questionnaire (EORTC–QLQ–C30).Results:The results of repeated-measures t tests showed statistically significant differences with respect to the dimensions of dignity, anxiety, spirituality, and quality of life for both groups. However, depression increased in the DT group after the intervention, and there were no differences with respect to resilience. Therapy in the counseling group did not negatively affect depression, and resilience did improve. When post-intervention differences between groups were calculated, statistically significant differences in anxiety were found, with lower scores in the counseling group (t(68) = –2.341, p = 0.022, d = 0.560).Significance of Results:Our study provided evidence for the efficacy of dignity therapy and counseling in improving the well-being of palliative home care patients, and it found better results in the counseling therapy group with respect to depression, resilience, and anxiety.

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