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.

The effect of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: A double-blind placebo-controlled trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9062-9062
Author(s):  
Egidio Del Fabbro ◽  
Rony Dev ◽  
David Hui ◽  
J. Lynn Palmer ◽  
Eduardo Bruera
Keyword(s):  
Quality Of Life ◽  
Weight Loss ◽  
Advanced Cancer ◽  
Interim Analysis ◽  
Controlled Trial ◽  
Well Being ◽  
Test Statistic ◽  
Double Blind ◽  
Edmonton Symptom Assessment Scale

9062 Background: Patients with advanced cancer experience anorexia and weight loss which impairs their quality of life. Prior studies suggest melatonin, a frequently used integrative medicine may attenuate weight loss, anorexia, fatigue, and depression. These studies were limited by a lack of blinding and absence of placebo controls. The primary objective of this study was to compare melatonin to placebo for appetite in patients with cachexia. Methods: A randomized, double-blind, 28 day trial of melatonin 20mg vs. placebo in patients with advanced lung or gastrointestinal cancer, appetite scores >3 on a 0 to 10 scale (10 = worst appetite) and a history of weight loss ≥ 5% within 6 months. Patients unable to maintain oral intake, thyroid or adrenal dysfunction, or with a karnofsky <40 were excluded from the study. The assessments included weight, symptom severity by Edmonton Symptom Assessment Scale (ESAS) and quality of life by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT).Differences between groups from baseline to day 28 were analyzed using one-sided two sample t tests (appetite, pain and well-being) or Wilcoxon two-sample tests for the other variables. Interim analysis at half point had a Lan-DeMets monitoring boundary with an O’Brien-Fleming stopping rule. The decision boundaries for the interim test was to accept the null hypothesis of no treatment difference (futility) if the test statistic Z < 0.39 (p ≥ 0.348). Results: After interim analysis of 48 patients, the study was closed by the Data Safety Monitoring Board for futility. There were no significant differences between groups in appetite (p=0.78), weight (p= 0.17), FAACT score (p=0.95), insomnia (p=0.62) or other symptoms measured by the ESAS from baseline to day 28.No significant toxicities were observed. Conclusions: In cachectic patients with advanced cancer, 20mg oral Melatonin at night does not improve appetite, weight or quality of life compared to placebo.

Testosterone replacement for fatigue in male hypogonadic patients with advanced cancer: A preliminary double-blind placebo-controlled trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19643-e19643
Author(s):  
Kalyan Pulivarthi ◽  
Rony Dev ◽  
Jose Garcia ◽  
J. Lynn Palmer ◽  
Eduardo Bruera ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Depression Scale ◽  
T Test ◽  
Testosterone Replacement ◽  
Double Blind ◽  
Significant Difference ◽  
Edmonton Symptom Assessment Scale

e19643 Background: Hypogonadism affects two thirds of men with advanced cancer. Uncontrolled studies show fatigue, anorexia, depression,and insomnia are associated with low testosterone in men with cancer. Testosterone replacement improves quality of life and diminishes fatigue in patients with non-cancer conditions. The primary goal of this study was to evaluate the effect of testosterone replacement on fatigue in hypogonadal males with advanced cancer, by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)at day 29. Methods: Randomized, double-blinded placebo controlled at two centers. Clinic outpatients with advanced cancer, bioavailable testosterone (BT) <70ng/dL, hemoglobin>9g/dL, and moderate to severe fatigue assessed by a score >3/10 on the Edmonton Symptom Assessment Scale (ESAS) were eligible.Contraindications to testosterone therapy or other causes of fatigue such as hypothyroidism, hypercalcemia, or chronic kidney disease excluded subjects. Weight-based intra-muscular testosterone or a sesame seed oil placebo administered every 14 days to achieve a BT level 70-270ng/dL. Initial sample size was for fifty evaluable patients per group. One-sided t test was used to analyze differences in FACIT scores between arms. Results: Accrual was slower than anticipated with a final total of 43 eligible males randomized to testosterone(19) or placebo(24). Neither age nor site was statistically significant (<0.05) between arms. 14 placebo and 12 testosterone treated patients were evaluable for the primary outcome.No statistically significant difference was found for FACIT-F total scores between arms, with a trend for testosterone to improve scores (-5.5±19 for placebo, 3.9±14 for testosterone, p=0.09) using a one-sided t test. Adverse events were similar between groups. There were no significant differences in secondary outcomes of ESAS scores, Hospital Anxiety and Depression Scale, hand-grip or 6 minute walk. Conclusions: Testosterone replacement in hypogonadal male patients with advanced cancer had a trend to improve fatigue and quality of life in this preliminary trial.

The time taken to complete quality of life questionnaires in an advanced cancer trial

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8592-8592
Author(s):  
M. R. Stockler ◽  
S. Heritier ◽  
A. K. Nowak ◽  
D. Goldstein ◽  
J. Turner ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Advanced Cancer ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Depression Scale ◽  
Well Being ◽  
Cancer Trial ◽  
Respondent Burden ◽  
Quality Of Life Questionnaires

8592 Background: Respondent burden is important when designing trials in advanced cancer. We determined the time taken to complete a set of quality of life questionnaires (TTTCQ) in a randomized trial of sertraline in advanced cancer. Methods: Participants recorded the times they started and finished an 11 page questionnaire of 187 items including the Centre for Epidemiologic Studies Depression Scale, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Therapy General and Fatigue scales, and 4 other validated instruments. Determinants of the TTTCQ were sought amongst the self-ratings of anxiety, depression, fatigue, trouble concentrating, other aspects of quality of life, and other characteristics including age, Karnofsky Performance Status (KPS) and treatment. Distributions are summarised by their median, interquartile range (25th to 75th percentiles, IQR) and interdecile range (10th to 90th percentiles, IDR). Associations were assessed with Spearman’s rank correlation coefficient (r), and differences with the Mann-Whitney test. All p-values are two-sided. Results: The TTTCQ was available for 128 of 150 subjects (85%). Median age was 66 (IQR 59 to 73), median KPS was 80 (IQR 70 to 90), and 63% were male. The median TTTCQ was 30 mins (IQR 23 to 40, IDR 15 to 50), equating to a median of 10 secs per item (IQR 7 to 13, IDR 5 to 16). The TTTCQ was modestly correlated with age and KPS (r = 0.19, p = 0.04 for both). Age and KPS were not correlated (r = 0.03, p = 0.8). Subjects aged 60 or older had a median TTTCQ 10 mins longer than those 59 or younger (35 v 25 mins, p = 0.002). Subjects with a KPS of 100, 90, 80, and 70 or less had a median TTTCQ of 20, 25, 31, and 35 mins respectively. TTTCQ was modestly correlated with self-ratings of: problems coping with treatment, dry mouth, feeling dizzy or lightheaded (r = 0.22 to 0.25, p = 0.01). Correlations were weak or non-existent with all measures of depression, anxiety, trouble concentrating, emotional well-being, and overall well-being (r = 0.10 to 0.18, p = 0.04 to 0.25). TTTCQ was unaffected by gender, opioids, steroids and number of previous cytotoxic regimens. Conclusions: Respondent burden was less of a problem than anticipated and little affected by treatments or self-rated psychological problems. No significant financial relationships to disclose.

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.

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.

scholarly journals Quality of life support in advanced cancer—web and technological interventions: systematic review and narrative synthesis

2021 ◽  
pp. bmjspcare-2020-002820
Author(s):  
Kathleen Kane ◽  
Fiona Kennedy ◽  
Kate L Absolom ◽  
Clare Harley ◽  
Galina Velikova
Keyword(s):  
Quality Of Life ◽  
Advanced Cancer ◽  
Life Support ◽  
Well Being ◽  
Narrative Synthesis ◽  
Monitoring Tools ◽  
Technological Interventions ◽  
Cancer Trajectory ◽  
Interactive Health Communication

BackgroundAs treatments continue to progress, patients with advanced cancer are living longer. However, ongoing physical side-effects and psychosocial concerns can compromise quality of life (QoL). Patients and physicians increasingly look to the internet and other technologies to address diverse supportive needs encountered across this evolving cancer trajectory.Objectives1. To examine the features and delivery of web and technological interventions supporting patients with advanced cancer. 2. To explore their efficacy relating to QoL and psychosocial well-being.MethodsRelevant studies were identified through electronic database searches (MEDLINE, PsychINFO, Embase, CINAHL, CENTRAL, Web of Science and ProQuest) and handsearching. Findings were collated and explored through narrative synthesis.ResultsOf 5274 identified records, 37 articles were included. Interventions were evaluated within studies targeting advanced cancer (13) or encompassing all stages (24). Five subtypes emerged: Interactive Health Communication Applications (n=12), virtual programmes of support (n=11), symptom monitoring tools (n=8), communication conduits (n=3) and information websites (n=3). Modes of delivery ranged from self-management to clinically integrated. Support largely targeted psychosocial well-being, alongside symptom management and healthy living. Most studies (78%) evidenced varying degrees of efficacy through QoL and psychosocial measures. Intervention complexity made it challenging to distinguish the most effective components. Incomplete reporting limited risk of bias assessment.ConclusionWhile complex and varied in their content, features and delivery, most interventions led to improvements in QoL or psychosocial well-being across the cancer trajectory. Ongoing development and evaluation of such innovations should specifically target patients requiring longer-term support for later-stage cancer.PROSPERO registration numberCRD42018089153.

Assessment of Quality of Life in Outpatients With Advanced Cancer: The Accuracy of Clinician Estimations and the Relevance of Spiritual Well-Being—A Hoosier Oncology Group Study

2003 ◽  
Vol 21 (14) ◽  
pp. 2754-2759 ◽  
Author(s):  
Michael J. Fisch ◽  
Michael L. Titzer ◽  
Jean L. Kristeller ◽  
Jianzhao Shen ◽  
Patrick J. Loehrer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Advanced Cancer ◽  
Performance Status ◽  
Well Being ◽  
Categorical Variables ◽  
Therapeutic Trial ◽  
Slight Variation ◽  
Cross Sectional ◽  
Spiritual Well Being

Purpose: To evaluate the association between quality-of-life (QOL) impairment as reported by patients and QOL impairment as judged by nurses or physicians, with and without consideration of spiritual well-being (SWB). Patients and Methods: A total of 163 patients with advanced cancer were enrolled onto a therapeutic trial, and cross-sectional data were derived from clinical and demographic questionnaires obtained at baseline, including assessment of patient QOL and SWB. Clinicians rated the QOL impairment of their patients as mild, moderate, or severe. Clinician-estimated QOL impairment and patient-derived QOL categories were compared. Correlation coefficients were estimated to associate QOL scores using different instruments. The analysis of variance method was used to compare Functional Assessment of Cancer Therapy–General scores on categorical variables. Results: There was no significant association between self-assessment scores and marital status, education level, performance status, or predicted life expectancy. However, a strong relationship between SWB and QOL was noted (P < .0001). Clinician-estimated QOL impairment matched the level of patient-derived QOL correctly in approximately 60% of cases, with only slight variation depending on the method of categorizing patient-derived QOL scores. The accuracy of clinician estimates was not associated with the level of SWB. Interestingly, a subset analysis of the inaccurate estimates revealed an association between lower SWB and clinician underestimation of QOL impairment (P = .0025). Conclusion: Clinician estimates of QOL impairment were accurate in more than 60% of patients. SWB is strongly associated with QOL, but it is not associated with the overall accuracy of clinicians’ judgments about QOL impairment.

P–478 Quality of life assessment in women undergoing assisted reproduction. A study of FertiQol and HADS

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
N Figueras-Puigderrajols ◽  
A Ballesteros ◽  
D Guerra
Keyword(s):  
Quality Of Life ◽  
Depression Scale ◽  
Well Being ◽  
Self Esteem ◽  
Mobile App ◽  
Life Assessment ◽  
Fertility Treatment ◽  
Anxiety And Depression ◽  
Gamete Donation

Abstract Study question The present study aims to explore infertility-related psychosocial outcomes, including fertility quality of life (QoL), as well as anxiety and depression levels, in women diagnosed with infertility. Summary answer Differences on fertility-related QoL appeared when comparing treatment types (gamete donation vs own gamete). Furthermore, statistically significant associations were found between QoL and anxious-depressive symptomatology. What is known already Those who wish to have children and do not achieve their objective just like other peers can see their goals and expectations with pessimism, generating concern and a series of negative emotions. Several psychological implications of infertility have been described, such as increased levels of stress, anxiety, depression, decreased self-esteem, mood and hope, or poor relationship adjustment. The emotional impact of infertility in people’s life cycle can be so strong that reducing it only to biological aspects would lead to a dangerous situation of neglect. For this reason, QoL assessment in ART becomes an important need. Study design, size, duration FertiQol stands as the most widely used tool to assess infertility-related QoL, overcoming the limitations of other instruments that only target specific medical conditions. The present is a multi-site cross-sectional study over patients with infertility (n = 104), aiming to explore their fertility-QoL, as well as their anxiety and depression levels, which are symptoms that have been previously associated.Questionnaire administration, and sociodemographic and medical data gathering took place between January 2019 and December 2020. Participants/materials, setting, methods Participants were 104 female patients (M.age= 39.8) undergoing or expecting a fertility treatment. The FertiQol Spanish version was administered through mobile app, and its paper version distributed at medical/psychological appointments. QoL was self-reported through FertiQol, assessing the influence of infertility problems in various areas (e.g. impact on self-esteem, emotions, general health, family, partners, social relationships, work, life projects...). Additionally, HADS (Hospital Anxiety and Depression Scale) was provided as a measurement of anxiety and depression levels. Main results and the role of chance Regarding treatments, 50.6% of participants were currently undergoing gamete donation while 44.3% were undergoing treatments that involved using their own gametes. After comparing QoL between these treatment types, results showed that patients who underwent egg donation, compared to those who used their own eggs, reported statistically significantly lower scores of QoL in the Social Subscale (p = .03), but not in the other psychological outcomes. Also, statistically significant negative correlations were found between HADS and all core FertiQol subscales (p&lt; .05). Results are consistent with previous studies showing similar associations between fertility QoL and anxiety and depression, as well as with increased psychological negative implications of gamete donation. The majority of participants reported non-pathological scores of anxiety and depression when considering the cut off value of 8 for HADS, thus suggesting the presence of a relatively healthy sample. The number of treatments that patients had previously taken and the years of infertility were not associated with any of the psychological variables. Limitations, reasons for caution Some limitations to consider are presence of co-morbid diagnosis, differences in medication, or patient’s cultural backgrounds.Also, conclusions should be interpreted cautiously since the design doesn’t allow causal inferences. Further investigations should consider a continuous assessment to explore changes in psychological well-being at different points of intervention, specially with gamete donation. Wider implications of the findings: The great advantage we’ve seen so far when using FertiQol is the possibility to identify more accurately the true impact on other aspects of patient’s well-being besides the emotional area.ART professionals, including psychologists and counselors,will have more information within a small amount of time about QoL when using this tool. Trial registration number 1503-BCN–019-DG

scholarly journals The ‘Cancer Home-Life Intervention’: A randomised controlled trial evaluating the efficacy of an occupational therapy–based intervention in people with advanced cancer

2018 ◽  
Vol 32 (4) ◽  
pp. 744-756 ◽  
Author(s):  
Marc Sampedro Pilegaard ◽  
Karen la Cour ◽  
Lisa Gregersen Oestergaard ◽  
Anna Thit Johnsen ◽  
Line Lindahl-Jacobsen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Health Related Quality ◽  
Home Life ◽  
Everyday Activities ◽  
Related Quality ◽  
Health Related ◽  
Randomised Controlled

Background: People with advanced cancer face difficulties with their everyday activities at home that may reduce their health-related quality of life. To address these difficulties, we developed the ‘Cancer Home-Life Intervention’. Aim: To evaluate the efficacy of the ‘Cancer Home Life-Intervention’ compared with usual care with regard to patients’ performance of, and participation in, everyday activities, and their health-related quality of life. Design and intervention: A randomised controlled trial ( ClinicalTrials.gov NCT02356627). The ‘Cancer Home-Life Intervention’ is a brief, tailored, occupational therapy–based and adaptive programme for people with advanced cancer targeting the performance of their prioritised everyday activities. Setting/participants: Home-living adults diagnosed with advanced cancer experiencing functional limitations were recruited from two Danish hospitals. They were assessed at baseline, and at 6 and 12 weeks of follow-up. The primary outcome was activities of daily living motor ability. Secondary outcomes were activities of daily living process ability, difficulty performing prioritised everyday activities, participation restrictions and health-related quality of life. Results: A total of 242 participants were randomised either to the intervention group ( n = 121) or the control group ( n = 121). No effect was found on the primary outcome (between-group mean change: −0.04 logits (95% confidence interval: −0.23 to 0.15); p = 0.69). Nor was any effect on the secondary outcomes observed. Conclusion: In most cases, the ‘Cancer Home-Life Intervention’ was delivered through only one home visit and one follow-up telephone contact, which not was effective in maintaining or improving participants’ everyday activities and health-related quality of life. Future research should pay even more attention to intervention development and feasibility testing.

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.

Sign in / Sign up

Export Citation Format

Share Document