Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors.
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ABSTRACT:
SUBMITTER: Krusche A
PROVIDER: S-EPMC6429898 | biostudies-literature | 2019 Mar
REPOSITORIES: biostudies-literature
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Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors.
Krusche Adele A Bradbury Katherine K Corbett Teresa T Barnett Jane J Stuart Beth B Yao Guiqing Lily GL Bacon Roger R Böhning Dankmar D Cheetham-Blake Tara T Eccles Diana D Foster Claire C Geraghty Adam William Alfred AWA Leydon Geraldine G Müller Andre A Neal Richard D RD Osborne Richard R Rathod Shanaya S Richardson Alison A Sharman Geoffrey G Summers Kevin K Watson Eila E Wilde Laura L Wilkinson Clare C Yardley Lucy L Little Paul P
BMJ open 20190301 3
<h4>Introduction</h4>Low quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activi ...[more]
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Project description:BackgroundRecurrent stroke is a major contributor to stroke-related disability and costs. Improving health-risk behaviours and mental health has the potential to significantly improve recovery, enhance health-related quality of life (HRQoL), independent living, and lower the risk of recurrent stroke. The primary aim will be to test the effectiveness of an online intervention to improve HRQoL among stroke survivors at 6 months' follow-up. Programme effectiveness on four health behaviours, anxiety and depression, cost-effectiveness, and impact on other hospital admissions will also be assessed.Methods/designAn open-label randomised controlled trial is planned. A total of 530 adults will be recruited across one national and one regional stroke registry and block randomised to the intervention or minimal care control group. The intervention group will receive access to the online programme Prevent 2nd Stroke (P2S); the minimal care control group will receive an email with Internet addresses of generic health sites designed for the general population. The primary outcome, HRQoL, will be measured using the EuroQol-5D. A full analysis plan will compare between groups from baseline to follow-up.DiscussionA low-cost per user option to supplement current care, such as P2S, has the potential to increase HRQoL for stroke survivors, and reduce the risk of second stroke.Trial registrationAustralian and New Zealand Clinical Trials Registry, ID: ACTRN12617001205325p . Registered on 17 August 2017.
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Project description:IntroductionMany stroke survivors have unmet psychosocial needs during the recovery phase following a stroke. There is emerging evidence that peer support interventions may play a valuable role in managing stroke. However, evidence regarding the effectiveness of peer support interventions on the psychosocial outcomes of stroke survivors is uncertain. This study aims to develop a nurse-led peer support intervention for stroke survivors based on the Person-Environment-Occupation-Performance Model and evaluate its effects on the psychosocial outcomes of stroke survivors.Methods and analysisThis is an assessor-blinded two-arm randomised controlled trial. A convenience sample of 120 stroke survivors will be recruited from two community centres and one rehabilitation unit in Yangzhou, a medium-sized city in eastern China, with 60 participants each in the intervention and control groups. The participants allocated to the intervention group will receive the nurse-led peer support intervention, which includes 6 weekly peer support sessions facilitated by a nurse and at least one peer facilitator. Participants randomised to the control group will receive the same dose of interpersonal interaction as intervention participants, including weekly individual face-to-face session for 6 weeks. The primary outcomes are social participation and participation self-efficacy. The secondary outcomes are psychosocial distress, social support, stigma towards disease, self-efficacy in managing chronic conditions and quality of life. Data will be collected at baseline, immediately after the intervention and 3 months after the intervention. A process evaluation will be conducted qualitatively and quantitively to examine the mechanism by which the intervention impacts the psychosocial outcomes of stroke survivors. All outcomes will be analysed following the intention to treat principle. Generalised Estimation Equation models will be used to assess the intervention effect.Ethics and disseminationThis protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2021.196-T). All participants will be required to provide written informed consent. Results of the study will be disseminated through publication in peer-reviewed journals and presentation at local or international conferences.Trial registration numberChiCTR2100050853.
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Project description:BackgroundThe aim of this trial was to evaluate the effectiveness of an online health behaviour change intervention-Prevent 2nd Stroke (P2S)-at improving health-related quality of life (HRQoL) amongst stroke survivors at 6 months of follow-up.Methods and findingsA prospective, blinded-endpoint randomised controlled trial, with stroke survivors as the unit of randomisation, was conducted between March 2018 and November 2019. Adult stroke survivors between 6 and 36 months post-stroke with capacity to use the intervention (determined by a score of ≥4 on the Modified Rankin Scale) and who had access and willingness to use the internet were recruited via mail-out invitations from 1 national and 1 regional stroke registry. Participants completed baseline (n = 399) and 6-month follow-up (n = 356; 89%) outcome assessments via computer-assisted telephone interviewing (CATI). At baseline the sample had an average age of 66 years (SD 12), and 65% were male. Randomisation occurred at the end of the baseline survey; CATI assessors and independent statisticians were blind to group allocation. The intervention group received remote access for a 12-week period to the online-only P2S program (n = 199; n = 28 lost at follow-up). The control group were emailed and posted a list of internet addresses of generic health websites (n = 200; n = 15 lost at follow-up). The primary outcome was HRQoL as measured by the EuroQol Visual Analogue Scale (EQ-VAS; self-rated global health); the outcome was assessed for differences between treatment groups at follow-up, adjusting for baseline measures. Secondary outcomes were HRQoL as measured by the EQ-5D (descriptive health state), diet quality, physical activity, alcohol consumption, smoking status, mood, physical functioning, and independent living. All outcomes included the variable 'stroke event (stroke/transient ischaemic attack/other)' as a covariate, and analysis was intention-to-treat. At 6 months, median EQ-VAS HRQoL score was significantly higher in the intervention group than the control group (85 vs 80, difference 5, 95% CI 0.79-9.21, p = 0.020). The results were robust to the assumption the data were missing at random; however, the results were not robust to the assumption that the difference in HRQoL between those with complete versus missing data was at least 3 points. Significantly higher proportions of people in the intervention group reported no problems with personal care (OR 2.17, 95% CI 1.05-4.48, p = 0.0359) and usual activities (OR 1.66, 95% CI 1.06-2.60, p = 0.0256) than in the control group. There were no significant differences between groups on all other secondary outcomes. The main limitation of the study is that the sample comprises mostly 'well' stroke survivors with limited to no disability.ConclusionsThe P2S online healthy lifestyle program improved stroke survivors' self-reported global ratings of HRQoL (as measured by EQ-VAS) at 6-month follow-up. Online platforms represent a promising tool to engage and support some stroke survivors.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12617001205325.
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Project description:BACKGROUND:The primary objective of this randomised controlled trial (RCT) is to establish the effectiveness of a novel online quality of life (QoL) intervention tailored for people with late stage (? 10 episodes) bipolar disorder (BD) compared with psychoeducation. Relative to early stage individuals, this late stage group may not benefit as much from existing psychosocial treatments. The intervention is a guided self-help, mindfulness based intervention (MBI) developed in consultation with consumers, designed specifically for web-based delivery, with email coaching support. METHODS/DESIGN:This international RCT will involve a comparison of the effectiveness and cost-effectiveness of two 5-week adjunctive online self-management interventions: Mindfulness for Bipolar 2.0 and an active control (Psychoeducation for Bipolar). A total of 300 participants will be recruited primarily via social media channels. Main inclusion criteria are: a diagnosis of BD (confirmed via a phone-administered structured diagnostic interview), no current mood episode, history of 10 or more mood episodes, no current psychotic features or active suicidality, under the care of a medical practitioner. Block randomisation will be used for allocation to the interventions, and participants will retain access to the program for 6 months. Evaluations will be conducted at pre- and post- treatment, and at 3- and 6- months follow-up. The primary outcome measure will be the Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD), collected immediately post-intervention at 5 weeks (T1). Secondary measures include BD-related symptoms (mania, depression, anxiety, stress), time to first relapse, functioning, sleep quality, social rhythm stability and resource use. Measurements will be collected online and via telephone assessments at baseline (T0), 5 weeks (T1), three months (T2) and six months (T3). Candidate moderators (diagnosis, anxiety or substance comorbidities, demographics and current treatments) will be investigated as will putative therapeutic mechanisms including mindfulness, emotion regulation and self-compassion. A cost-effectiveness analysis will be conducted. Acceptability and any unwanted events (including adverse treatment reactions) will be documented and explored. DISCUSSION:This definitive trial will test the effectiveness and cost-effectiveness of a novel QoL focused, mindfulness based, online guided self-help intervention for late stage BD, and investigate its putative mechanisms of therapeutic action. TRIAL REGISTRATION:ClinicalTrials.gov : NCT03197974 . Registered 23 June 2017.
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Project description:BackgroundPrimary care plays an important role in supporting survivors of cancer; however, support is limited because of practitioners' perceived lack of expertise and time. A digital intervention for survivors of cancer could provide an efficient way for primary care staff to support survivors of cancer without the need to accumulate expertise and skills to help patients make behavior changes; providing very brief support alongside this could maximize adherence to digital interventions. Renewed is a digital intervention that combines web-based behavior change advice with brief health care practitioner support from a nurse or health care assistant. Knowledge about the views and experiences of primary care staff providing support alongside a digital intervention for survivors of cancer is sparse, limiting the understanding of the acceptability and feasibility of this type of intervention.ObjectiveThis study aims to explore supporters' experiences of providing support to survivors of cancer using Renewed, understand potential barriers to and facilitators of the implementation of Renewed in practice, and investigate the strengths and weaknesses of the intervention from the perspective of health care professionals.MethodsThis was a qualitative process evaluation nested within a large trial evaluating Renewed. A total of 28 semistructured telephone interviews were conducted with nurses and health care assistants. Data were analyzed using inductive thematic analysis.ResultsFour themes were developed during the analysis, which reflected the factors that supporters identified as hindering or enabling them to provide support alongside Renewed Online: Renewed Online as an acceptable digital tool with some improvements, confidence in enacting the supporter role, practicalities of delivering support alongside a digital intervention, and managing a patient-led approach. The analysis suggests that supporters perceived that a digital intervention such as Renewed would be beneficial in supporting survivors of cancer in primary care and fit within current practices. However, barriers to providing support alongside the intervention were also identified, including concerns about how to facilitate rapport building and, in a minority, concerns about using a nondirective approach, in which most advice and support is provided through digital interventions, with brief additional support provided by primary care staff.ConclusionsThese findings add to the literature on how best to provide support alongside digital interventions, suggesting that although most practitioners cope well with a nondirective approach, a minority requires more training to feel confident in implementing this. This study suggests that the barriers to providing formal support to survivors of cancer in primary care could be successfully overcome with an approach such as Renewed, where a digital intervention provides most of the support and expertise, and health care practitioners provide additional brief human support to maximize engagement. Strategies to maximize the chances of successful implementation for this type of intervention are also discussed.
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| S-EPMC9204413 | biostudies-literature
Project description:BackgroundDespite the evidence that many stroke survivors report longer term unmet needs, the provision of longer term care is limited. To address this, we are conducting a programme of research to develop an evidence-based and replicable longer term care strategy. The developed complex intervention (named New Start), which includes needs identification, exploration of social networks and components of problem solving and self-management, was designed to improve quality of life by addressing unmet needs and increasing participation.Methods/designA multicentre, cluster randomised controlled feasibility trial designed to inform the design of a possible future definitive cluster randomised controlled trial (cRCT) and explore the potential clinical and cost-effectiveness of New Start. Ten stroke services across the UK will be randomised on a 1:1 basis either to implement New Start or continue with usual care only. New Start will be delivered by trained facilitators and will be offered to all stroke survivors within the services allocated to the intervention arm. Stroke survivors will be eligible for the trial if they are 4-6 months post-stroke and residing in the community. Carers (if available) will also be invited to take part. Invitation to participate will be initiated by post and outcome measures will be collected via postal questionnaires at 3, 6 and 9 months after recruitment. Outcome data relating to perceived health and disability, wellbeing and quality of life as well as unmet needs will be collected. A 'study within a trial' (SWAT) is planned to determine the most acceptable format in which to provide the postal questionnaires. Details of health and social care service usage will also be collected to inform the economic evaluation. The feasibility of recruiting services and stroke survivors to the trial and of collecting postal outcomes will be assessed and the potential for effectiveness will be investigated. An embedded process evaluation (reported separately) will assess implementation fidelity and explore and clarify causal assumptions regarding implementation.DiscussionThis feasibility trial with embedded process evaluation will allow us to gather important and detailed data regarding methodological and implementation issues to inform the design of a possible future definitive cRCT of this complex intervention.Trial registrationISRCTN38920246 . Registered 22 June 2016.
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Project description:PurposeLymphoma survivors experience persisting needs as a consequence of disease and treatment, which have an impact on quality of life (QoL). There is evidence supporting the use of relaxation and exercise to improve QoL, but there is no agreement on which is more beneficial. This study aims to compare a relaxation intervention versus an exercise intervention to determine which has a greater impact on QoL post-chemotherapy.MethodsEligible participants (n = 46) were randomised to a relaxation or exercise intervention for 12 weeks. QoL was assessed at baseline, 6 weeks and post-intervention using the European Organisation for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30) questionnaire, which is a valid and reliable tool. The summary score and all EORTC domains were assessed.ResultsThere was a significant difference in QoL post-intervention between groups (p = 0.029) while adjusting for baseline QoL, with the exercise group demonstrating a larger improvement. Within-group QoL significantly improved pre- to post-intervention in both the relaxation (p = 0.036) and exercise (p = 0.004) groups.ConclusionsA self-management intervention of either exercise or relaxation can help significantly improve QoL in lymphoma survivors following chemotherapy. While exercise is preferred, a relaxation intervention would also have a beneficial impact on QoL.Implications for cancer survivorsLymphoma survivors should be routinely screened and those with decreased QoL referred for an exercise programme, or relaxation for survivors who are unable to exercise or choose not to. A home-based programme can have a significant positive impact on QoL and is a feasible and effective method in the current climate.Trial registration numberClinical Trials ID NCT02272751.
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Project description:BackgroundThe Holocaust was one of the most traumatic catastrophes in recorded human history. Survivors seeking psychotherapeutic help today, now in their seventies and older, often show symptoms of a posttraumatic stress disorder (PTSD), depression, or prolonged grief disorder. Established psychological treatments for PTSD (e.g. cognitive behaviour therapy, psychodynamic therapies) have been tested and assessed mainly with young and middle-aged adults; only very few studies examined them in old age. There is no therapy outcome study known to us for any treatment mode for Holocaust survivors. Moreover, there is a need for an age group-specific treatment of PTSD and other stress-related mental disorders. A narrative approach including life-review and narrative exposure seems to meet very well the natural need of older people to review their lives and is highly effective. However, most studies on the efficacy of life review therapy (LRT) focus on late-life depression. There is a lack of efficacy studies evaluating the effect of LRT on PTSD symptoms in older individuals that have experienced traumatic events.MethodsThe main goal of this study is to evaluate the effect of LRT for Holocaust survivors (LRT-HS) on symptoms of PTSD and related mental health problems (depression, anxiety, prolonged grief), compared to a supportive control group. A secondary goal is to identify the characteristics of participants that seem to especially benefit from the treatment. The proposed study is a randomised, controlled follow-up trial including Holocaust survivors with one or more trauma-related disorders. The LRT treatment consists of 20-25 sessions. Before and after the treatment phase, participants in both conditions will be assessed. Follow-up will take place 6 months after the treatment. A sample size of 80 is required (drop-out rate included).DiscussionEfficacious treatments for trauma-related disorders in older people are of high importance, also because the probability of traumatisation and loss increases with age. Because this study is conducted with this specific group of multiply traumatised people, we are convinced that the results can easily transfer to other samples.Trial registrationISRCTN, ISRCTN12823306. Registered 31 March 2018 - Retrospectively registered (first participant 22 December 2017).
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Project description:IntroductionEffective, brief, low-cost interventions for suicide attempt survivors are essential to saving lives and achieving the goals of the National Strategy for Suicide Prevention and Zero Suicide. This study aims to examine the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP) in averting suicide reattempts in the United States healthcare system, its psychological mechanisms as predicted by the Interpersonal Theory of Suicide, and the potential implementation costs, barriers and facilitators for delivering it.Methods and analysisThis study is a hybrid type 1 effectiveness-implementation randomised controlled trial (RCT). ASSIP is delivered at three outpatient mental healthcare clinics in New York State. Participant referral sites include three local hospitals with inpatient and comprehensive psychiatric emergency services, and outpatient mental health clinics. Participants include 400 adults who have had a recent suicide attempt. All are randomised to 'Zero Suicide-Usual Care plus ASSIP' or 'Zero Suicide-Usual Care'. Randomisation is stratified by sex and whether the index attempt is a first suicide attempt or not. Participants complete assessments at baseline, 6 weeks, and 3, 6, 12 and, 18 months. The primary outcome is the time from randomisation to the first suicide reattempt. Prior to the RCT, a 23-person open trial took place, in which 13 participants received 'Zero Suicide-Usual Care plus ASSIP' and 14 completed the first follow-up time point.Ethics and disseminationThis study is overseen by the University of Rochester, with single Institutional Review Board (#3353) reliance agreements from Nathan Kline Institute (#1561697) and SUNY Upstate Medical University (#1647538). It has an established Data and Safety Monitoring Board. Results will be published in peer-reviewed academic journals, presented at scientific conferences, and communicated to referral organisations. Clinics considering ASSIP may use a stakeholder report generated by this study, including incremental cost-effectiveness data from the provider point of view.Trial registration numberNCT03894462.
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