scholarly journals Protocol for ‘Resilient Caregivers’: a randomised trial of a resilience-based intervention for psychologically distressed partner caregivers of patients with cancer

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e048327
Author(s):  
Peter Genter ◽  
Beverley Lim Høeg ◽  
Camilla Jensen Hamre ◽  
Elisabeth Anne Wreford Andersen ◽  
Susanne Oksbjerg Dalton ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Patients With Cancer ◽  
Registration Number ◽  
Resilience Framework ◽  
Reflective Skills ◽  
Written Informed Consent

IntroductionIntimate partners of patients with cancer often experience significant distress, but there is a lack of psychological interventions that specifically target this population. ‘Resilient Caregivers’ is a novel resilience-based intervention for distressed partner cancer caregivers. The intervention was developed according to a resilience framework focusing on meta-reflective skills, coping strategies and value clarification. The aim of this study is to evaluate the effectiveness of this intervention in a randomised trial.Methods and analysisEighty participants will be invited through the Oncology Department at Herlev Hospital, Denmark and randomised to either the intervention or usual care. Participants are eligible if they are partners (married or unmarried) of patients diagnosed with cancer and experience distress (>4 on the distress thermometer). ‘Resilient Caregivers’ consists of seven manualised group sessions (2.5 hours each), focusing on resilience in relation to being a partner caregiver of a patient with cancer. The primary outcome is symptoms of anxiety, while secondary outcomes include distress, depression, quality of life, sleep quality and resilience. Data will be collected at baseline, 3, 6 and 12 months follow-up using validated scales, and analysed using mixed models for repeated measures.Ethics and disseminationThis study will follow the ethical principles in the Declaration of Helsinki and has been reviewed by the Ethics Committee of the Capital Region of Denmark (Journal no. 18055373). Written informed consent will be obtained from all participants. Results will be reported through scientific peer-reviewed journals and relevant conferences.Trial registration numberNCT04610034.

scholarly journals Reducing emotional distress in people caring for patients receiving specialist palliative care

2007 ◽  
Vol 190 (2) ◽  
pp. 142-147 ◽  
Author(s):  
Kiri Walsh ◽  
Louise Jones ◽  
Adrian Tookman ◽  
Christina Mason ◽  
Joanne McLoughlin ◽  
...  
Keyword(s):  
Palliative Care ◽  
Primary Outcome ◽  
General Health Questionnaire ◽  
Intervention Group ◽  
Additional Advantage ◽  
Patients With Cancer ◽  
Secondary Outcomes ◽  
Informal Carers

BackgroundCaring for relatives with advanced cancer may cause psychological and physical ill health.AimsTo evaluate the effectiveness of increased support for distressed, informal carers of patients receiving palliative care.MethodThe sample was composed of 271 informal carers who scored over 5 on the 28-item General Health Questionnaire (GHQ-28). The intervention comprised six weekly visits by a trained advisor. Primary outcome was carer distress (GHQ-28) at 4-week, 9-week and 12-week follow-up. Secondary outcomes were carer strain and quality of life, satisfaction with care, and bereavement outcome.ResultsScores on the GHQ-28 fell below the threshold of 5/6 in a third of participants in each trial arm at any follow-up point. Mean scores in the intervention group were lower at all time points but these differences were not significant. No difference was observed in secondary outcomes. Carers receiving the intervention reported qualitative benefit.ConclusionsThe intervention might have been too brief, and ongoing help might have had accruing benefits. Alternatively, informal carers of patients with cancer may already receive considerable input and the advisor's help gave little additional advantage; or caring for a dying relative is extremely stressful and no amount of support is going to make it much better.

scholarly journals Integrating vocational rehabilitation and mental healthcare to improve the return-to-work process for people on sick leave with depression or anxiety: results from a three-arm, parallel randomised trial

2021 ◽  
pp. oemed-2021-107894
Author(s):  
Andreas Hoff ◽  
Rie Mandrup Poulsen ◽  
Jonas Fisker ◽  
Carsten Hjorthøj ◽  
Nicole Rosenberg ◽  
...  
Keyword(s):  
Sick Leave ◽  
Return To Work ◽  
Vocational Rehabilitation ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Mental Healthcare ◽  
Stress Symptoms ◽  
Registration Number ◽  
Anxiety Depression

ObjectiveThe aim of this study was to investigate an integrated mental healthcare and vocational rehabilitation intervention to improve and hasten the process of return-to-work of people on sick leave with anxiety and depression.MethodsIn this three-arm, randomised trial, participants were assigned to (1) integrated intervention (INT), (2) improved mental healthcare (MHC) or (3) service as usual (SAU). The primary outcome was time to return-to-work measured at 12-month follow-up. The secondary outcomes were time to return-to-work measured at 6-month follow-up; levels of anxiety, depression, stress symptoms, and social and occupational functioning at 6 months; and return-to-work measured as proportion in work at 12 months.Results631 individuals were randomised. INT yielded a higher proportion in work compared with both MHC (56.2% vs 43.7%, p=0.012) and SAU (56.2% vs 45%, p=0.029) at 12-month follow-up. We found no differences in return-to-work in terms of sick leave duration at either 6-month or 12-month follow-up, with the latter being the primary outcome. No differences in anxiety, depression or functioning between INT, MHC and SAU were identified, but INT and MHC showed lower scores on Cohen’s Perceived Stress Scale compared with SAU at 12-month follow-up.ConclusionsAlthough INT did not hasten the process of return-to-work, it yielded better outcome with regard to proportion in work compared with MHC and SAU. The findings suggest that INT compared with SAU is associated with a few, minor health benefits. Overall, INT yielded slightly better vocational and health outcomes, but the clinical significance of the health advantage is questionable.Trial registration numberNCT02872051.

scholarly journals Hypotension in Preterm Infants (HIP) randomised trial

2021 ◽  
pp. fetalneonatal-2020-320241
Author(s):  
Eugene M Dempsey ◽  
Keith J Barrington ◽  
Neil Marlow ◽  
Colm Patrick Finbarr O'Donnell ◽  
Jan Miletin ◽  
...  
Keyword(s):  
Brain Injury ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Intraventricular Haemorrhage ◽  
Standard Group ◽  
Double Blind ◽  
Group Assignment ◽  
Standard Management ◽  
Postmenstrual Age ◽  
Registration Number

ObjectiveTo determine whether restricting the use of inotrope after diagnosis of low blood pressure (BP) in the first 72 hours of life affects survival without significant brain injury at 36 weeks of postmenstrual age (PMA) in infants born before 28 weeks of gestation.DesignDouble-blind, placebo-controlled randomised trial. Caregivers were masked to group assignment.Setting10 sites across Europe and Canada.ParticipantsInfants born before 28 weeks of gestation were eligible if they had an invasive mean BP less than their gestational age that persisted for ≥15 min in the first 72 hours of life and a cerebral ultrasound free of significant (≥ grade 3) intraventricular haemorrhage.InterventionParticipants were randomly assigned to saline bolus followed by either a dopamine infusion (standard management) or placebo (5% dextrose) infusion (restrictive management).Primary outcomeSurvival to 36 weeks of PMA without severe brain injury.ResultsThe trial terminated early due to significant enrolment issues (7.7% of planned recruitment). 58 infants were enrolled between February 2015 and September 2017. The two groups were well matched for baseline variables. In the standard group, 18/29 (62%) achieved the primary outcome compared with 20/29 (69%) in the restrictive group (p=0.58). Additional treatments for low BP were used less frequently in the standard arm (11/29 (38%) vs 19/29 (66%), p=0.038).ConclusionThough this study lacked power, we did not detect major differences in clinical outcomes between standard or restrictive approach to treatment. These results will inform future studies in this area.Trial registration numberNCT01482559, EudraCT 2010-023988-17.

scholarly journals Quality of Life and Hemodynamic Effects of Switching From Hemodialysis to Hemodiafiltration: A Canadian Controlled Cohort Study

2021 ◽  
Vol 8 ◽  
pp. 205435812110577
Author(s):  
Isabelle Ethier ◽  
Immaculate Nevis ◽  
Rita S. Suri
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Repeated Measures ◽  
Recovery Time ◽  
Randomized Clinical Trials ◽  
Analysis Of Covariance ◽  
Intradialytic Hypotension ◽  
Laboratory Values

Background: Recent randomized clinical trials have demonstrated beneficial effects of hemodiafiltration (HDF) compared with hemodialysis (HD) on mortality and hemodynamic stability. Data on quality of life in HDF compared with HD is limited. Objective: This study aimed to determine whether patients receiving HD experience improvements in quality of life, hemodynamic and laboratory parameters after switching to HDF. Design: Observational controlled cohort study. Setting & Patients: Adult patients receiving maintenance dialysis were followed for 3 months both before and after transfer to a new unit, where they received HDF. Prior to transfer, control patients were already treated by HDF. Methods: Quality of life at baseline and follow-up was measured using the validated minutes to recovery (MR) question. Dialysis data were collected for 3 consecutive sessions monthly; laboratory values were collected monthly. Wilcoxon signed rank test and repeated measures analysis of covariance were used to evaluate pre/post transfer changes and quantile regression to identify predictors of change in recovery time. Results: Of 227 patients, 82 died, were transplanted, were hospitalized or did not transfer, leaving 123 subjects and 22 controls for analysis. MR did not improve with switching to HDF, although patients with MR > 60 min before transfer experienced a significant decrease in their MR, compared with controls. There was no improvement in intradialytic hypotension with HDF. There were no differences in laboratory values before vs after switch. Limitations: Nonrandomized single-center study, including only small numbers of patients and covering a short follow-up period; hemodynamic values only evaluated over 1 week per month; residual kidney function not recorded. Conclusions: In this Canadian experience of HDF, patients remained stable with respect to several laboratory and dialysis related parameters. Switch to HDF was associated with substantially reduced recovery time in patients with MR > 60 minutes at baseline.

scholarly journals Long-Term Patient Satisfaction and Quality of Life After Breast-Conserving Therapy: A Prospective Study Using the BREAST-Q

2021 ◽  
Author(s):  
Ilona Stolpner ◽  
Jörg Heil ◽  
Fabian Riedel ◽  
Markus Wallwiener ◽  
Benedikt Schäfgen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Risk Factors ◽  
Patient Satisfaction ◽  
Repeated Measures ◽  
Aesthetic Surgery ◽  
Well Being ◽  
Breast Conserving Therapy ◽  
Patient Reported

Abstract Background Poor patient-reported satisfaction after breast-conserving therapy (BCT) has been associated with impaired health-related quality of life (HRQOL) and subsequent depression in retrospective analysis. This prospective cohort study aimed to assess the HRQOL of patients who have undergone BCT using the BREAST-Q, and to identify clinical risk factors for lower patient satisfaction. Methods Patients with primary breast cancer undergoing BCT were asked to complete the BREAST-Q preoperatively (T1) for baseline evaluation, then 3 to 4 weeks postoperatively (T2), and finally 1 year after surgery (T3). Clinicopathologic data were extracted from the patients’ charts. Repeated measures analysis of variance (ANOVA) was used to determine significant differences in mean satisfaction and well-being levels among the test intervals. Multiple linear regression was used to evaluate risk factors for lower satisfaction. Results The study enrolled 250 patients. The lowest baseline BREAST-Q score was reported for “satisfaction with breast” (mean, 61 ± 19), but this increased postoperatively (mean, 66 ± 18) and was maintained at the 1 year follow-up evaluation (mean, 67 ± 21). “Physical well-being” decreased from T1 (mean, 82 ± 17) to T2 (mean, 28 ± 13) and did not recover much by T3 (mean, 33 ± 13), being the lowest BREAST-Q score postoperatively and in the 1-year follow-up evaluation. In multiple regression, baseline psychosocial well-being, body mass index (BMI), and type of incision were risk factors for lower “satisfaction with breasts.” Conclusion Both the aesthetic/surgery-related and psychological aspects are equally important with regard to “satisfaction with breasts” after BCT. The data could serve as the benchmark for future studies.

scholarly journals Effectiveness of expanding annual mass azithromycin distribution treatment coverage for trachoma in Niger: a cluster randomised trial

2017 ◽  
Vol 102 (5) ◽  
pp. 680-686 ◽  
Author(s):  
Abdou Amza ◽  
Boubacar Kadri ◽  
Beido Nassirou ◽  
Sun Y Cotter ◽  
Nicole E Stoller ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Randomised Trial ◽  
Chlamydia Infection ◽  
Cluster Randomised Trial ◽  
Active Trachoma ◽  
Treatment Coverage ◽  
Significant Difference ◽  
Registration Number ◽  
Rate Of Decline ◽  
Antibiotic Coverage

Background/aimsThe WHO recommends 3–5 years of annual mass azithromycin distribution with at least 80% treatment coverage to districts with active trachoma prevalence over 10% among children. Here, we assess the efficacy of expanding the coverage target to at least 90% for trachoma control in a mesoendemic region of Niger.MethodsTwenty-four communities were randomised to a single day of azithromycin distribution with a coverage target of 80% of the community or up to 4 days of treatment, aiming for greater than 90% coverage. Distributions were annual and individuals above 6 months of age were treated. Children under 5 years of age were monitored for ocular chlamydia infection and active trachoma.ResultsAt baseline, ocular chlamydia prevalence was 20.5% (95% CI 9.8% to 31.2%) in the standard coverage arm and 21.9% (95% CI 11.3% to 32.5%) in the enhanced coverage arm, which reduced to 4.6% (95% CI 0% to 9.5%, p=0.008) and 7.1% (95% CI 2.7% to 11.4%, p<0.001) at 36 months, respectively. There was no significant difference in 36-month ocular chlamydia prevalence between the two arms (p=0.21). There was no difference in the rate of decline in ocular chlamydia between the two arms in a repeated measures model (p=0.80).ConclusionsFor annual mass azithromycin distribution programme to an entire community, there may be no additional benefit of increasing antibiotic coverage above the WHO’s 80% target.Trial registration numberNCT00792922, post-results.

Sleep Pattern and Predictors of Sleep Disturbance Among Family Caregivers of Terminal Ill Patients With Cancer in Taiwan: A Longitudinal Study

2018 ◽  
Vol 35 (8) ◽  
pp. 1109-1117 ◽  
Author(s):  
Kwo-Chen Lee ◽  
Ya-Ling Hsieh ◽  
Pi-Chu Lin ◽  
Yun-Ping Lin
Keyword(s):  
Longitudinal Study ◽  
Sleep Quality ◽  
Sleep Disturbance ◽  
Family Caregivers ◽  
Terminally Ill ◽  
Patients With Cancer ◽  
Terminally Ill Patients ◽  
Prospective Longitudinal

Background: Sleep disturbance commonly has a negative impact on the well-being of family caregivers (FCs) of terminally ill patients with cancer. The effect of sleep disturbance on FCs has not been explored through long-term follow-up studies in Taiwan. Objective: The purposes of this study were to (1) identify the trajectory of sleep quality of FCs of terminally ill patients with cancer in Taiwan and (2) examine the determinants of sleep disturbance through a longitudinal follow-up until patient death. Methods: A prospective, longitudinal study was conducted among 95 FCs of terminally ill patients with cancer. The FCs’ sleep quality was measured subjectively by using the Pittsburgh Sleep Quality Index and objectively by wearing a wrist actigraphy for 48 hours each month during the 6-month follow-up assessments. The trajectory and determinants of sleep quality were identified using a generalized estimation equation approach. Results: The FCs’ sleep quality significantly decreased as the patient’s death approached. Family caregivers who were women or older, had a relative with a longer survival period after diagnosis, reported higher levels of depression and fatigue, and provided lower levels of assistance to their relatives experienced more sleep disturbance. Conclusion: The sleep quality of Taiwanese FCs significantly deteriorated as the death of the terminally ill patients with cancer approached. Early detection of the FCs’ sleep disturbance, increasing their self-awareness of sleep problems, and providing nonpharmacological interventions and psychosocial support may be helpful for FCs to improve their quantity and quality of sleep.

scholarly journals Managing Pain in Patients With Cancer: The Chinese Good Pain Management Experience

2017 ◽  
Vol 3 (5) ◽  
pp. 583-595 ◽  
Author(s):  
Shi-Ying Yu ◽  
Jie-Jun Wang ◽  
Yu-guang Huang ◽  
Bing Hu ◽  
Kun Wang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Management ◽  
High Standard ◽  
Management Training ◽  
Drug Dose ◽  
Dose Titration ◽  
Patients With Cancer ◽  
Opioid Drugs

Purpose The number of cancer cases in China has increased rapidly from 2.1 million in 2000 to 4.3 million in 2015. As a consequence, pain management as an integral part of cancer treatment became an important health care issue. In March 2011, the Good Pain Management (GPM) program was launched to standardize the treatment of cancer pain and improve the quality of life for patients with cancer. With this work, we will describe the GPM program, its implementation experience, and highlight key lessons that can improve pain management for patients with cancer. Methods We describe procedures for the selection, implementation, and assessment procedures for model cancer wards. We analyzed published results in areas of staff training and patient education, pain management in practice, analgesic drugs administration, and patient follow-up and satisfaction. Results Pain management training enabled medical staff to accurately assess the level of pain and to provide effective pain relief through timely dispensation of medication. Patients with good knowledge of treatment of pain were able to overcome their aversion to opioid drugs and cooperate with nursing staff on pain assessment to achieve effective drug dose titration. Consumption of strong opioid drugs increased significantly; however, there was no change for weaker opioids. Higher pain remission rates were achieved for patients with moderate-to-severe pain levels. Proper patient follow-up after discharge enabled improved outcomes to be maintained. Conclusion The GPM program has instituted a consistent and high standard of care for pain management at cancer wards and improved the quality of life for patients with cancer.

scholarly journals Frailty and the Kidney Transplant Wait List: Protocol for a Multicenter Prospective Study

2020 ◽  
Vol 7 ◽  
pp. 205435812095743
Author(s):  
Karthik K. Tennankore ◽  
Lakshman Gunaratnam ◽  
Rita S. Suri ◽  
Seychelle Yohanna ◽  
Michael Walsh ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Kidney Transplant ◽  
Repeated Measures ◽  
Primary Outcome ◽  
Frailty Index ◽  
Wait List ◽  
Relative Hazard ◽  
Risk Of Death ◽  
Secondary Outcomes

Background: Understanding how frailty affects patients listed for transplantation has been identified as a priority research need. Frailty may be associated with a high risk of death or wait-list withdrawal, but this has not been evaluated in a large multicenter cohort of Canadian wait-listed patients. Objective: The primary objective is to evaluate whether frailty is associated with death or permanent withdrawal from the transplant wait list. Secondary objectives include assessing whether frailty is associated with hospitalization, quality of life, and the probability of being accepted to the wait list. Design: Prospective cohort study. Setting: Seven sites with established renal transplant programs that evaluate patients for the kidney transplant wait list. Patients: Individuals who are being considered for the kidney transplant wait list. Measurements: We will assess frailty using the Fried Phenotype, a frailty index, the Short Physical Performance Battery, and the Clinical Frailty Scale at the time of listing for transplantation. We will also assess frailty at the time of referral to the wait list and annually after listing in a subgroup of patients. Methods: The primary outcome of the composite of time to death or permanent wait-list withdrawal will be compared between patients who are frail and those who are not frail and will account for the competing risks of deceased and live donor transplantation. Secondary outcomes will include number of hospitalizations and length of stay, and in a subset, changes in frailty severity over time, change in quality of life, and the probability of being listed. Recruitment of 1165 patients will provide >80% power to identify a relative hazard of ≥1.7 comparing patients who are frail to those who are not frail for the primary outcome (2-sided α = .05), whereas a more conservative recruitment target of 624 patients will provide >80% power to identify a relative hazard of ≥2.0. Results: Through December 2019, 665 assessments of frailty (inclusive of those for the primary outcome and all secondary outcomes including repeated measures) have been completed. Limitations: There may be variation across sites in the processes of referral and listing for transplantation that will require consideration in the analysis and results. Conclusions: This study will provide a detailed understanding of the association between frailty and outcomes for wait-listed patients. Understanding this association is necessary before routinely measuring frailty as part of the wait-list eligibility assessment and prior to ascertaining the need for interventions that may modify frailty. Trial Registration: Not applicable as this is a protocol for a prospective observational study.

scholarly journals Evaluation of a positive psychotherapy group intervention for people with psychosis: pilot randomised controlled trial

2015 ◽  
Vol 25 (3) ◽  
pp. 235-246 ◽  
Author(s):  
Beate Schrank ◽  
Tamsin Brownell ◽  
Zivile Jakaite ◽  
Charley Larkin ◽  
Francesca Pesola ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Group Intervention ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Self Esteem ◽  
Positive Psychotherapy ◽  
Main Effect ◽  
Randomised Controlled

Aims.Third-wave psychological interventions have gained relevance in mental health service provision but their application to people with psychosis is in its infancy and interventions targeting wellbeing in psychosis are scarce. This study tested the feasibility and preliminary effectiveness of positive psychotherapy adapted for people with psychosis (WELLFOCUS PPT) to improve wellbeing.Methods.WELLFOCUS PPT was tested as an 11-week group intervention in a convenience sample of people with psychosis in a single centre randomised controlled trial (ISRCTN04199273) involving 94 people with psychosis. Patients were individually randomised in blocks to receive either WELLFOCUS PPT in addition to treatment as usual (TAU), or TAU only. Assessments took place before randomisation and after the therapy. The primary outcome was wellbeing (Warwick-Edinburgh Mental Well-Being Scale, WEMWBS). Secondary outcomes included symptoms (Brief Psychiatric Rating Scale), depression (Short Depression-Happiness Scale), self-esteem, empowerment, hope, sense of coherence, savouring beliefs and functioning, as well as two alternative measures of wellbeing (the Positive Psychotherapy Inventory and Quality of Life). Intention-to-treat analysis was performed. This involved calculating crude changes and paired-sample t-tests for all variables, as well as ANCOVA and Complier Average Causal Effect (CACE) Analysis to estimate the main effect of group on all outcomes.Results.The intervention and trial procedures proved feasible and well accepted. Crude changes between baseline and follow-up showed a significant improvement in the intervention group for wellbeing according to all three concepts assessed (i.e., WEMWBS, Positive Psychotherapy Inventory and Quality of Life), as well as for symptoms, depression, hope, self-esteem and sense of coherence. No significant changes were observed in the control group. ANCOVA showed no main effect on wellbeing according to the primary outcome scale (WEMWBS) but significant effects on symptoms (p = 0.006, ES = 0.42), depression (p = 0.03, ES = 0.38) and wellbeing according to the Positive Psychotherapy Inventory (p = 0.02, ES = 0.30). Secondary analysis adapting for therapy group further improved the results for symptom reduction (p = 0.004, ES = 0.43) and depression (p = 0.03, ES = 0.41) but did not lead to any more outcomes falling below the p = 0.05 significance level. CACE analysis showed a non-significant positive association between the intervention and WEMWBS scores at follow-up (b = 0.21, z = 0.9, p = 0.4).Conclusions.This study provides initial evidence on the feasibility of WELLFOCUS PPT in people with psychosis, positively affecting symptoms and depression. However, more work is needed to optimise its effectiveness. Future research might evaluate positive psychotherapy as a treatment for comorbid depression in psychosis, and consider alternative measurements of wellbeing.

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