Internet-based guided self-help for glioma patients with depressive symptoms: design of a randomized controlled trial Internet-based guided self-help for glioma patients with depressive symptoms: a randomized controlled trial Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. A guided self-help intervention targeting psychological distress among head and neck cancer and lung cancer patients: motivation to start, experiences and perceived outcomes A qualitative exploration of barriers and facilitatorsto adherence to an online self-help intervention for cancer-related distress The Role of User Control in Adherence to and Knowledge Gained from a Website: Randomized Comparison Between a Tunneled Version and a Freedom-of-Choice Version Effects of exercise intervention in breast cancer patients: is mobile health (mHealth) with pedometer more effective than conventional program using brochure? Finding My Way: protocol of a randomised controlled trial evaluating an internet self-help program for cancer-related distress A pilot randomized controlled trial of the feasibility of a self-directed coping skills intervention for couples facing prostate cancer: Rationale and design The Patient Remote Intervention and Symptom Management System (PRISMS) – a Telehealth- mediated intervention enabling real-time monitoring of chemotherapy side-effects in patients with haematological malignancies: study protocol for a randomised controlled trial Long-term effects of a web-based cancer aftercare intervention on moderate physical activity and vegetable consumption among early cancer survivors: a randomized controlled trial CONSORT-EHEALTH: Implementation of a Checklist for Authors and Editors to Improve Reporting of Web-Based and Mobile Randomized Controlled Trials CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
Background Among glioma patients , depression is estimated to be more prevalent than in both the general population and the cancer patient population . This can have negative consequences for both patients and their primary informal caregivers ( e.g. , a spouse , family member or close friend ) . At present , there is no evidence from r and omized controlled trials for the effectiveness of psychological treatment for depression in glioma patients . Furthermore , the possibility of delivering mental health care through the internet has not yet been explored in this population . Therefore , a r and omized controlled trial is warranted to evaluate the effects of an internet-based , guided self-help intervention for depressive symptoms in glioma patients . Methods / design The intervention is based on problem-solving therapy . An existing 5-week course is adapted for use by adult glioma patients with mild to moderate depressive symptoms ( Center for Epidemiology Studies Depression Scale score ≥12 ) . Sample size calculations yield 126 glioma patients to be included , who are r and omly assigned to either the intervention group or a waiting list control group .  In addition , we aim to include 63 patients with haematological cancer in a non- central nervous system malignancy control group . Assessment s take place at baseline , after 6 and 12 weeks , and after 6 and 12 months . Primary outcome measure is the change in depressive symptoms . Secondary outcome measures include health-related quality of life , fatigue , costs and patient satisfaction . In addition , all patients are asked to assign a primary informal caregiver , who does not participate in the intervention but who is asked to complete similar assessment s. Their mood , health-related quality of life and fatigue is evaluated as well . Discussion This is the first study to evaluate the effects of problem-solving therapy delivered through the internet as treatment for depressive symptoms in glioma patients . If proven effective , this treatment will contribute to the mental health care of glioma patients in clinical practice .Trial registration Netherl and s Trial Register Abstract Depressive symptoms are common in glioma patients , and can negatively affect health-related quality of life ( HRQOL ) . We performed a nation-wide r and omized controlled trial to evaluate the effects of an online guided self-help intervention for depressive symptoms in adult glioma patients . Glioma patients with depressive symptoms were r and omized to a 5-week online course based on problem-solving therapy , or a waiting list control group . After having received the intervention , the glioma patient groups combined were compared with patients with cancer outside the central nervous system ( non-CNS cancer controls ) , who also received the intervention . Sample size calculations yielded 63 participants to be recruited per arm . The primary outcome [ depressive symptoms ( CES-D ) ] and secondary outcomes [ fatigue ( Checklist Individual Strength ( CIS ) ) and HRQOL ( Short Form-36 ) ] , were assessed online at baseline , post-intervention , and 3 and 12 months follow-up . In total , 89 glioma patients ( intervention N = 45 ; waiting list N = 44 ) and 26 non-CNS cancer controls were included , of whom 35 and 54 % completed the intervention , respectively . Recruitment could not be extended beyond 3.5 years due to funding . On depression , no statistically significant differences between the groups were found . Fatigue decreased post-treatment in the glioma intervention group compared with the waiting list group ( p = 0.054 , d = 0.306 ) . At 12 months , the physical component summary ( HRQOL ) remained stable in glioma patients , while scores improved in non-CNS cancer controls ( p = 0.035 , d = 0.883 ) . In this underpowered study , no evidence for the effectiveness of online guided self-help for depression or HRQOL in glioma patients was found , but it may improve fatigue . Trial registration Netherl and s Trial Register NTR3223 CONTEXT The Consoli date d St and ards for Reporting of Trials ( CONSORT ) statement was developed to help improve the quality of reports of r and omized controlled trials ( RCTs ) . To date , a paucity of data exists regarding whether it has achieved this goal . OBJECTIVE To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs . DESIGN AND SETTING Comparative before- and -after evaluation in which reports of RCTs published in 1994 ( pre-CONSORT ) were compared with RCT reports from the same journals published in 1998 ( post-CONSORT ) . We included 211 reports from BMJ , JAMA , and The Lancet ( journals that adopted CONSORT ) as well as The New Engl and Journal of Medicine ( a journal that did not adopt CONSORT and was used as a comparator ) . MAIN OUTCOME MEASURES Number of CONSORT items included in a report , frequency of unclear reporting of allocation concealment , and overall trial quality score based on the Jadad scale , a 5-point quality assessment instrument . RESULTS Compared with 1994 , the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998 , and this increase was statistically significant for the 3 adopter journals ( pre-CONSORT , 23.4 ; mean change , 3.7 ; 95 % confidence interval [ CI ] , 2.1 - 5.3 ) . The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals , and this change was statistically significant for adopters ( pre-CONSORT , 61 % ; mean change , -22 % ; 95 % CI , -38 % to -6 % ) . Similarly , 3 of the 4 journals showed an improvement in the quality score for reports of RCTs , and this increase was statistically significant for adopter journals overall ( pre-CONSORT , 2.7 ; mean change , 0.4 ; 95 % CI , 0.1 - 0.8 ) . CONCLUSION Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs Background Recent results of a r and omized clinical trial showed that a guided self-help intervention ( based on problem-solving therapy ) targeting psychological distress among head and neck cancer and lung cancer patients is effective . This study qualitatively explored motivation to start , experiences with and perceived outcomes of this intervention . Methods Data were collected from semi-structured interviews of 16 patients . All interviews were audio-recorded and transcribed verbatim . Data were analyzed individually by two coders and coded into key issues and themes . Results Patients participated in the intervention for intrinsic ( e.g. to help oneself ) and for extrinsic reasons ( e.g. being asked by a care professional or to help improve health care ) . Participants indicated positive and negative experiences with the intervention . Several participants appreciated participating as being a pleasant way to work on oneself , while others described participating as too confrontational . Some expressed their disappointment as they felt the intervention had brought them nothing or indicated that they felt worse temporarily , but most participants perceived positive outcomes of the intervention ( e.g. feeling less distressed and having learned what matters in life ) . Conclusions Cancer patients have various reasons to start a guided self-help intervention . Participants appreciated the guided self-help as intervention to address psychological distress , but there were also concerns . Most participants reported the intervention to be beneficial . The results suggest the need to identify patients who might benefit most from guided self-help targeting psychological distress and that interventions should be further tailored to individual cancer patients ’ requirements Objective This study qualitatively explored barriers and facilitators of adherence to an online psychological intervention for cancer-related distress . Methods Semi-structured interviews were conducted with 13 adults with cancer , r and omised to receive either a 6-week intervention ( n = 8) or attention control ( n = 5 ) as part of a larger RCT . Transcripts were coded for themes and subthemes , and recruitment ceased when saturation of themes occurred . Results Adherence overall was high : six participants completed all six modules , three completed five modules , two completed four modules , one completed one module , and one did not access the program . The total numbers of barriers ( n = 19 ) and facilitators ( n = 17 ) identified were equivalent and were categorised into five overarching themes : illness factors , psychological factors , personal factors , intervention factors and computer factors . However , the prevalence with which themes were discussed differed : illness factors ( specifically cancer treatment side effects ) were the main reported barrier to adherence ; intervention factors ( email reminders , program satisfaction , ease of use , program content ) were the most common facilitators . Conclusion While some factors were cited as both facilitating and barring adherence , and therefore reflective of personal preferences and circumstances , a number of recommendations were derived regarding ( i ) the best timing for online interventions and ( ii ) the need for multi-platform programs Background Internet-delivered interventions can effectively change health risk behaviors and their determinants , but adherence to these interventions once they are accessed is very low . Therefore , it is relevant and necessary to systematic ally manipulate website characteristics to test their effect on website use . This study focuses on user control as a website characteristic . Objective To test whether and how user control ( the freedom of choice to skip pages ) can increase website use and knowledge gained from the website . Methods Participants older than 18 years were drawn from the Dutch Internet population ( in June 2011 ) and completed a hepatitis knowledge question naire . Subsequently , they were r and omly assigned to three groups : ( 1 ) a tunneled version of the website with less user control ; ( 2 ) a high user control version of the website where visitors had the freedom of choice to skip pages ; and ( 3 ) a control group that was not exposed to the website . Participants completed ( 1 ) a question naire of vali date d measures regarding user perceptions immediately after exposure to the website ( except for the control group ) , and ( 2 ) a  hepatitis knowledge question naire after one week to test whether participants in the experimental groups only clicked through the website or actually processed and learned its content . Server registration s were used to assess website use . Analyses of covariance ( ANCOVA ) using all available data were conducted to determine whether user control increases website use . Structural equation models ( SEM ) using all available data were constructed to test how user control increases website use — a latent variable derived from number of pages visited and time on website . Results Of the 1044 persons invited to participate , 668 took part ( 668/1044 , 64.0 % ) . One half of participants ( 332/668 49.7 % ) were female and the mean age was 49 years ( SD 16 ) . A total of 571 participants completed the one-week follow-up measure regarding hepatitis knowledge ( 571/668 , 85.5 % ) . The findings demonstrate that having less user control ( ie , a tunneled version of the website ) had a negative effect on users ’ perception of efficiency ( F1,452 = 97.69 , P < .001 ) , but a positive effect on number of pages visited ( F1,452 = 171.49 , P < .001 ) , time on the website ( F1,452 = 6.32 , P = .01 ) , and knowledge gained from the website ( F1,452 = 134.32 , P < .001 ) . The direct effect of having less user control appeared to surpass the effect mediated by efficiency , because website use was higher among participants exposed to the tunneled version of the website in comparison with those having the freedom of choice to skip pages . Conclusions The key finding that visitors demonstrated increased website use in the tunneled version of the website indicates that visitors should be carefully guided through the intervention for future intervention websites Purpose To investigate and compare the effects of mobile health ( mHealth ) and pedometer with conventional exercise program using a brochure on physical function and quality of life ( QOL ) . Methods The study was a prospect i ve , quasi-r and omized multicenter trial where 356 patients whose cancer treatment had been terminated were enrolled . All patients were instructed to perform a 12-week regimen of aerobic and resistance exercise . The mHealth group received a pedometer and a newly developed smartphone application to provide information and monitor the prescribed exercises . Those in the conventional group received an exercise brochure . Physical measurements were conducted at baseline , 6 weeks , and 12 weeks . Self-reported physical activity ( international physical activity question naire-short form ) , general QOL ( European Organization for Research and Treatment of Cancer Quality of Life Question naire Core 30 ) , and breast cancer-specific QOL ( Quality of Life Question naire Breast Cancer Module 23 ) were assessed at baseline and 12 weeks . A user satisfaction survey was assessed in the mHealth group . Results Basic characteristics were not different between the two groups except for age and previous radiotherapy . Physical function , physical activity , and QOL scores were significantly improved regardless of the intervention method , and changes were not significantly different between the two groups . Additionally , the mean Likert scale response for overall satisfaction with the service was 4.27/5 in the mHealth group . Conclusions Overall , both the mHealth coupled with pedometer and conventional exercise education using a brochure were effective in improving physical function , physical activity , and QOL . This study provides a basis of mHealth research in breast cancer patients for progressing further developing field , although superiority of the mHealth over the conventional program was not definitely evident Background A cancer diagnosis elicits greater distress than any other medical diagnosis , and yet very few studies have evaluated the efficacy of structured online self-help therapeutic programs to alleviate this distress . This study aims to assess the efficacy over time of an internet Cognitive Behaviour Therapy ( iCBT ) intervention ( ‘ Finding My Way ’ ) in improving distress , coping and quality of life for individuals with a recent diagnosis of early stage cancer of any type . Methods / Design The study is a multi-site R and omised Controlled Trial ( RCT ) seeking to enrol 188 participants who will be r and omised to either the Finding My Way Intervention or an attention-control condition .  Both conditions are delivered online ; with 6 modules released once per week , and an additional booster module released one month after program-completion . Participants complete online question naires on 4 occasions : at baseline ( immediately prior to accessing the modules ) ; post-treatment ( immediately after program-completion ) ; then three and six months later . Primary outcomes are general distress and cancer-specific distress , with secondary outcomes including Health-Related Quality of Life ( HRQoL ) , coping , health service utilisation , intervention adherence , and user satisfaction . A range of baseline measures will be assessed as potential moderators of outcomes . Eligible participants are individuals recently diagnosed with any type of cancer , being treated with curative intent , aged over 18 years with sufficient English language literacy , internet access and an active email account and phone number . Participants are blinded to treatment group allocation . R and omisation is computer generated and stratified by gender . Discussion Compared to the few prior published studies , Finding My Way will be the first adequately powered trial to offer an iCBT intervention to curatively treated patients of heterogeneous cancer types in the immediate post-diagnosis/treatment period . If found efficacious , Finding My Way will assist with overcoming common barriers to face-to-face therapy in a cost-effective and accessible way , thus helping to reduce distress after cancer diagnosis and consequently decrease the cancer burden for individuals and the health system . Trial registration Australian New Zeal and Clinical Trials Registry ACTRN12613000001796 Background Although it is known both patients ’ and partners ’ reactions to a prostate cancer diagnosis include fear , uncertainty , anxiety and depression , with patients ’ and partners ’ reactions mutually determining how they cope with and adjust to the illness , few psychosocial interventions target couples . Those that are available tend to be led by highly trained professionals , limiting their accessibility and long-term sustainability . In addition , it is recognised that patients who might benefit from conventional face-to-face psychosocial interventions do not access these , either by preference or because of geographical or mobility barriers . Self-directed interventions can overcome some of these limitations and have been shown to contribute to patient well-being . This study will examine the feasibility of a self-directed , coping skills intervention for couples affected by cancer , called Coping-Together , and begin to explore its potential impact on couples ’ illness adjustment . The pilot version of Coping-Together includes a series of four booklets , a DVD , and a relaxation audio CD . Methods / design In this double-blind , two-group , parallel , r and omized controlled trial , 70 couples will be recruited within 4 months of a prostate cancer diagnosis through urology private practice s and r and omized to : 1 ) Coping-Together or 2 ) a minimal ethical care condition . Minimal ethical care condition couples will be mailed information booklets available at the Cancer Council New South Wales and a brochure for the Cancer Council Helpline . The primary outcome ( anxiety ) and additional secondary outcomes ( distress , depression , dyadic adjustment , quality of life , illness or caregiving appraisal , self-efficacy , and dyadic and individual coping ) will be assessed at baseline ( before receiving study material ) and 2 months post-baseline . Intention-to-treat and per protocol analysis will be conducted . Discussion As partners ’ distress rates exceed not only population norms , but also those reported by patients themselves , it is imperative that coping skills interventions target the couple as a unit and enhance both partners ’ ability to overcome cancer challenges . This pilot study will examine the feasibility and potential efficacy of Coping-Together in optimising couples ’ illness adjustment . This is one of the first feasibility studies to test this innovative coping intervention , which in turn will contribute to the larger literature advocating for psychosocial care of couples affected by prostate cancer . Trial registration Australian New Zeal and Clinical Trials Registry Background Outpatient chemotherapy is a core treatment for haematological malignancies ; however , its toxicities frequently lead to distressing/potentially life-threatening side-effects ( neutropenia/infection , nausea/vomiting , mucositis , constipation/diarrhoea , fatigue ) . Early detection/management of side-effects is vital to improve patient outcomes , decrease morbidity and limit lengthy/costly hospital admissions . The ability to capture patient-reported health data in real-time , is regarded as the ‘ gold-st and ard ’ to allow rapid clinical decision-making/intervention . This paper presents the protocol for a Phase 3 multi-site r and omised controlled trial evaluating a novel nurse-led Telehealth intervention for remote monitoring/management of chemotherapy side-effects in Australian haematological cancer patients . Methods / Design Two hundred and twenty-two patients will be recruited from two hospitals . Eligibility criteria include : diagnosis of chronic lymphocytic leukaemia/Hodgkin’s/non-Hodgkin ’s lymphoma ; aged ≥ 18 years ; receiving ≥ 2 cycles chemotherapy . Patients will be r and omised 1:1 to either the control or intervention arm with stratification by diagnosis , chemotherapy toxicity ( high versus low ) , receipt of previous chemotherapy and hospital . Patients allocated to the control arm will receive ‘ Usual Care ’ whilst those allocated to the intervention will receive the intervention in addition to ‘ Usual Care ’ . Intervention patients will be provided with a computer tablet and software prompting twice-daily completion of physical/emotional scales for up to four chemotherapy cycles . Should patient data exceed pre-determined limits an Email alert is delivered to the treatment team , prompting nurses to view patient data , and contact the patient to provide clinical intervention . In addition , six scheduled nursing interventions will be completed to educate/support patients in use of the software . Patient outcomes will be measured cyclically ( midpoint and end of cycles ) via pen- and -paper self-report alongside review of the patient medical record . The primary outcome is burden due to nausea , mucositis , constipation and fatigue . Secondary outcomes include : burden due to vomiting and diarrhoea ; psychological distress ; ability to self-manage health ; level of cancer information/support needs and ; utilisation of health services . Analyses will be intention-to-treat . A cost-effectiveness analysis is planned . Discussion This trial is the first in the world to test a remote monitoring/management intervention for adult haematological cancer patients receiving chemotherapy . Future use of such interventions have the potential to improve patient outcomes /safety and decrease health care costs by enabling early detection/ clinical intervention . Trial registration ACTRN12614000516684 . Date registered : 12 March 2014 ( registered retrospectively ) Background The number of cancer survivors is growing . Negative physical and psychosocial consequences of cancer treatment can occur during survivorship . Following healthy lifestyle recommendations is beneficial to increase quality of life and to reduce the risk of cancer recurrence and comorbidities . To meet individual needs , web-based interventions can supply a large population of cancer survivors with easily accessible and personalized information . Evidence concerning the long-term effects of web-based cancer aftercare interventions on lifestyle outcomes is limited . The present study evaluates the 12-month effects of a fully automated web-based cancer aftercare intervention . We investigated whether the previously determined 6-month effects on moderate physical activity and vegetable intake were maintained over 12 months . Possible moderator effects of using specific intervention modules , gender , age , and education were also explored . Method A two-armed r and omized controlled trial was conducted using online self-report question naires among survivors of various types of cancer ( N = 462 ) . The intervention group had access to the online intervention for 6 months , and the control group received access after 12-months . Multilevel linear regression analyses ( complete cases and intention-to-treat ) were conducted to explore 12- month effects . Results A significant intervention effect after 12 months was found for moderate physical activity ( complete cases : B = 128.475 , p = .010 , d = .35 ; intention-to-treat : B = 129.473 , p = .011 ) . Age was the only significant moderator ( p = .010 ) , with the intervention being effective among participants aged younger than 57 years ( B = 256.549 , p = .000 , d = .59 ) . No significant intervention effect remained for vegetable consumption after 12 months ( complete cases : B = 5.860 , p = .121 ; intention – to-treat : B = 5.560 , p = .132 ) . Conclusion The online cancer after care intervention is effective in increasing and maintaining moderate physical activity in the long term among early cancer survivors younger than 57 years . Short-term increases in vegetable consumption were not sustained in the long term . These findings indicate the value and potential of eHealth interventions for cancer survivors . Based on the study results , web-based self-management interventions could be recommended for younger cancer survivors ( < 57 years of age ) as a possible method to increase physical activity . Trial registration Dutch Trial Register NTR3375 . Registered 29 March 2012 BACKGROUND R and omized trials of web-based and mobile interventions pose very specific issues and challenges . A set of best practice s on how to conduct and report such trials was recently summarized in the CONSORT-EHEALTH statement ( Consoli date d St and ards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth ) , published in August 2011 as draft and in December 2011 as journal article ( V1.6.1 ) . The purpose of this presentation is to review the results of the pilot implementation at the Journal of Medical Internet Research ( JMIR ) , a leading eHealth journal , where reporting of trials in accordance with CONSORT-EHEALTH became m and atory in late 2011 . METHODS Authors of all r and omized trials su bmi tted to JMIR were asked to complete an electronic question naire , which involved copying pertinent manuscript sections into a CONSORT EHEALTH data base form , were asked to score the importance of CONSORT EHEALTH items , and were asked to provide narrative feedback on the value of the process . RESULTS Between August 2011 and November 2012 , 67 r and omized trials were su bmi tted , of which 61 were intended for publication in JMIR . Authors reported that it took between 1 and 16 hours to complete the checklist including making required changes to their manuscripts . 72 % ( 48/67 ) of authors reported they made minor changes to the manuscript , 6 % ( 4/67 ) made major changes . Most authors felt it was a useful process that improved their manuscripts : 63 % ( 42/67 ) said it improved their manuscript , 13 % ( 9/67 ) said it did not , 12 % ( 8/67 ) indicated that it had improved a little . CONCLUSIONS The CONSORT EHEALTH statement and checklist appeared successful in improving the quality of reporting . The checklist should be endorsed and used by authors and editors of other journals The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . To encourage dissemination of the CONSORT 2010 Statement , this article is freely accessible on bmj.com and will also be published in the Lancet , Obstetrics and Gynecology , PLoS Medicine , Annals of Internal Medicine , Open Medicine , Journal of Clinical Epidemiology , BMC Medicine , and Trials
Purpose of review The purpose of this article is to provide an up date d review exploring the recent developments in the field of self-guided interventions and describe the state of knowledge .