Dataset Information

Internet-based cognitive rehabilitation for WORking Cancer survivors (i-WORC): study protocol of a randomized controlled trial.

ABSTRACT:

Background

Cognitive problems are common in non-central nervous system cancer survivors. These problems are perceived as an important contributor to decline in work performance and work ability. Various interventions for cognitive problems have been proposed, but effectiveness regarding work-related outcomes has not yet been established. Effective treatment options to alleviate the adverse influence of cognitive problems on work performance are needed for working cancer survivors. In this paper, we will describe the design of a randomized, controlled, multicenter trial that evaluates the (cost-)effectiveness of an Internet-based cognitive rehabilitation program for occupationally active cancer survivors confronted with cognitive problems.

Methods/ design

A three-armed randomized controlled trial will be conducted, including two intervention groups (i.e., basic and extensive cognitive rehabilitation program) and one waitlist control group. In total, 261 cancer survivors (18-65?years) who have returned to work and who experience cognitive problems will be recruited. Patients with and without cognitive impairment as established in a neuropsychological assessment will be eligible; stratification will take place based on the presence of this cognitive impairment. The extensive intervention arm will contain a comprehensive training program (including psycho-education, fatigue management, and cognitive strategy training) with individual guidance (blended intervention). The basic intervention arm will contain a brief cognitive training program (including psycho-education and fatigue management) without individual guidance. The primary outcome will be accomplishment of an individually defined work-related treatment goal. Secondary outcomes include, among others, subjective cognitive functioning, work functioning, and quality of life. Primary and secondary outcomes will be measured at baseline (T0) and at 12?weeks (T1) and 26?weeks (T2) post-randomization.

Discussion

About 40-50% of the cancer patients worldwide are of working age at time of diagnosis. Many of the occupationally active cancer survivors experience cognitive problems. Both from an individual and a societal perspective, it is important to sustain cancer survivors' employability. An effective treatment to alleviate the impact of cognitive decline and to improve work ability might help cancer survivors to sustain employability.

Trial registration

ClinicalTrials.gov NCT03900806 . Registered on 03 April 2019 (current status: ongoing).

SUBMITTER: Klaver KM

PROVIDER: S-EPMC7372808 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Publications

Internet-based cognitive rehabilitation for WORking Cancer survivors (i-WORC): study protocol of a randomized controlled trial.

Klaver Kete M KM Duijts Saskia F A SFA Geusgens Chantal A V CAV Aarts Maureen J B MJB Ponds Rudolf W H M RWHM van der Beek Allard J AJ Schagen Sanne B SB

Trials 20200720 1

<h4>Background</h4>Cognitive problems are common in non-central nervous system cancer survivors. These problems are perceived as an important contributor to decline in work performance and work ability. Various interventions for cognitive problems have been proposed, but effectiveness regarding work-related outcomes has not yet been established. Effective treatment options to alleviate the adverse influence of cognitive problems on work performance are needed for working cancer survivors. In thi ...[more]

PMID: 32690067

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Project description:BackgroundPremenstrual syndrome (PMS) is a common problem of women of reproductive age, affecting various aspects of their lives. However, limited studies have investigated the effect of internet-based cognitive-behavioral therapy (ICBT) on PMS. Therefore, we aimed to assess whether ICBT can reduce symptom severity of women with PMS and improve their quality of life during the perimenstrual and late follicular phases of menstrual cycle.MethodsThe study included 92 university students aged 18-35 years who had moderate to severe PMS. The participants were allocated into two groups of 46 using block randomization. The intervention group underwent ICBT for two menstrual cycles, while the control group received no intervention. Before and after the intervention, all participants filled the Daily Record of Severity of Problems (DRSP) for two menstrual cycles and the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) on days 1-2 and 11-13 of the menstrual cycle. Data were analyzed using univariate general linear models.ResultsFour students in the intervention group were lost to follow-up. Following the intervention, the mean score of total PMS symptoms was significantly lower in the intervention group than in the control group (10.4 vs. 20.2, adjusted difference: - 9.9 [95% CI - 13.3 to - 6.6]), and the score of perimenstrual quality of life was significantly higher (64.2 vs. 50.3, 14.1 [8.5 to 19.8]). However, there was no significant intergroup difference in the late follicular quality of life (68.3 vs. 67.3, 1.9 [- 4.4 to 8.1]).ConclusionsThe ICBT could reduce the symptom severity of women suffering from PMS while improving their perimenstrual quality of life. However, it had no significant effect on the late follicular quality of life. Therefore, this intervention can be used for women with PMS. Trial registration The Iranian Registry of Clinical Trials, Identifier: IRCT20100414003706N34, Registered prospectively on 19 June 2019, https://www.irct.ir/trial/38394 .

Project description:INTRODUCTION:Depression and fatigue are common in breast cancer survivors, and their presence is associated with personal suffering and worse prognosis. While many women receive short-term psychological support in the acute treatment phase, this is rarely available in subsequent phases. Internet interventions for breast cancer survivors could provide additional psychological support, as they are easily accessible and may be effective. However, no trial has yet examined the effectiveness of an Internet intervention that provides cognitive behavioural therapy techniques plus lifestyle advice for this population. This trial aims to test whether Optimune, a novel Internet intervention we developed for that purpose, leads to improvements in quality of life and relevant lifestyle habits over the course of 3 to 6 months. METHODS:This randomized controlled trial (RCT) will include 360 female breast cancer survivors who have completed the active tumour eradication phase. Participants will be recruited from various settings, including web-based advertisements and Internet forums in German-speaking countries. The main inclusion criteria are a breast cancer diagnosis less than 5?years ago and completion of acute treatment at least 1?month ago, as verified by discharge letter from an oncology treatment centre. Participants will be randomly assigned to either (1) a control group, in which they receive care as usual (CAU) and are given access to Optimune after a delay of 3?months (CAU/wait list control), or (2) a treatment group that may also use CAU and will receive 12-month access to Optimune immediately after randomization. The three primary endpoints are quality of life, physical activity and diet quality, assessed with the World Health Organization Quality of Life Questionnaire, the International Physical Activity Questionnaire and the Food Quality Questionnaire, at 3 months post-baseline; secondary outcomes include cancer-related fatigue, emotional stress, depression, anxiety, fear of progression, insomnia, usefulness of the programme and negative treatment effects. Online assessments are conducted at baseline (T0), 3 months (T1) and 6 months (T2). DISCUSSION:Results of this RCT are expected to extend the body of knowledge with regard to the effectiveness of CBT-based Internet interventions for female breast cancer survivors. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03643640. Registered on 23 August 2018.

Project description:Menopausal symptoms are common and may be particularly severe in younger women who undergo treatment-induced menopause. Medications to reduce menopausal symptoms are either contra-indicated or have bothersome side effects. Previous studies have demonstrated that face-to-face cognitive behavioral therapy (CBT) is effective in alleviating menopausal symptoms in women with breast cancer. However, compliance with face-to-face CBT programs can be problematic. A promising approach is to use the Internet to make this form of CBT more accessible and feasible for patients. This study is evaluating the efficacy and cost-effectiveness of an Internet-based CBT program, with or without therapist guidance, in alleviating or reducing the severity of menopausal symptoms.In a multicenter, randomized controlled trial we are evaluating the efficacy of two Internet-based CBT programs in alleviating or reducing the impact of menopausal symptoms, and particularly hot flushes and night sweats, in breast cancer survivors who have experienced a treatment-induced menopause. Secondary outcomes include sexual functioning, sleep quality, hot flush frequency, psychological distress, health-related quality of life and cost-effectiveness. We will recruit 248 women who will be randomized to either a therapist guided or a self-management version of the 6-week Internet-based CBT program, or to a usual care, waiting list control group. Self-administered questionnaires are completed at baseline (T0), and at 10 weeks (T1) and 24 weeks (T2) post-randomization.Internet-based CBT is a potentially useful treatment for reducing menopausal symptoms in breast cancer survivors. This study will provide evidence on the efficacy and cost-effectiveness of such an Internet-based CBT program, with or without therapist support. If demonstrated to be efficacious and cost-effective, the availability of such structured supportive intervention programs will be a welcome addition to standard medical treatment offered to cancer patients with treatment-induced menopause.The study is retrospectively registered at ClinicalTrials.gov on January 26th 2016 ( NCT02672189 ).

Project description:BACKGROUND:Obsessive-compulsive disorder (OCD) is a highly disabling psychological disorder with a chronic course if left untreated. Cognitive behavioral therapy (CBT) has been shown to be an effective treatment, but access to face-to-face CBT is not always possible. Internet-based CBT (iCBT) has become an increasingly viable option. However, no study has compared iCBT to an analogous control condition using a randomized controlled trial (RCT). OBJECTIVE:A 2-armed RCT was used to compare a therapist-assisted 12-module iCBT to an analogous active attention control condition (therapist-assisted internet-based standard progressive relaxation training, iPRT) in adult OCD. This paper reports pre-post findings for OCD symptom severity. METHOD:In total, 179 participants (117 females, 65.7%) were randomized (stratified by gender) into iCBT or iPRT. The iCBT intervention included psychoeducation, mood and behavioral management, exposure and response prevention (ERP), cognitive therapy, and relapse prevention; the iPRT intervention included psychoeducation and relaxation techniques as a way of managing OCD-related anxiety but did not incorporate ERP or other CBT elements. Both treatments included audiovisual content, case stories, demonstrations of techniques, downloadable audio content and worksheets, and expert commentary. All participants received 1 weekly email, with a maximum 15-minute preparation time per client from a remote therapist trained in e-therapy. Emails aimed to monitor progress, provide support and encouragement, and assist in individualizing the treatment. Participants were assessed for baseline and posttreatment OCD severity with the telephone-administered clinician-rated Yale-Brown Obsessive-Compulsive Scale and other measures by assessors who were blinded to treatment allocation. RESULTS:No pretreatment differences were found between the 2 conditions. Intention-to-treat analysis revealed significant pre-post improvements in OCD symptom severity for both conditions (P<.001). However, relative to iPRT, iCBT showed significantly greater symptom severity improvement (P=.001); Cohen d for iCBT was 1.05 (95% CI 0.72-1.37), whereas for iPRT it was 0.48 (95% CI 0.22-0.73). The iCBT condition was superior in regard to reliable improvement (25/51, 49% vs 16/55, 29%; P=.04) and clinically significant pre-post-treatment changes (17/51, 33% vs 6/55, 11%; P=.005). Those undertaking iCBT post completion of iPRT showed further significant symptom amelioration (P<.001), although the sequential treatment was no more efficacious than iCBT alone (P=.63). CONCLUSION:This study is the first to compare a therapist-assisted iCBT program for OCD to an analogous active attention control condition using iPRT. Our findings demonstrate the large magnitude effect of iCBT for OCD; interestingly, iPRT was also moderately efficacious, albeit significantly less so than the iCBT intervention. The findings are compared to previous internet-based and face-to-face CBT treatment programs for OCD. Future directions for technology-enhanced programs for the treatment of OCD are outlined. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12611000321943; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336704 (Archived by WebCite at http://www.webcitation.org/70ovUiOmd).

Project description:BackgroundMild cognitive impairment (MCI) is defined as an intermediate stage between normal aging and Alzheimer's disease (AD), and early and easily available interventions to delay the progress of MCI to AD are necessary. Feasible complementary and alternative therapies such as electroacupuncture (EA), exercise, and cognitive training have shown some beneficial effects on MCI and AD. Here we report the protocol for a randomized controlled trial of the efficacy and safety of EA combined with computer-based cognitive rehabilitation (EA-CCR) for the treatment of MCI.MethodsThe study will be a prospective, outcome assessor-blinded, parallel-arm, single-center (DongShin University Gwangju Korean Medicine Hospital, Republic of Korea), pilot randomized controlled clinical trial with a 1:1 allocation ratio. Participants with MCI will be randomized to a computer-based cognitive rehabilitation (CCR) or an EA-CCR group (n?=?18 each). The CCR group will receive RehaCom cognitive rehabilitation once (30?min) a day, 3?days per week (excluding Saturday and Sunday) for 8?weeks. The EA-CCR group will receive EA at Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), and Shenting (GV24) in addition to RehaCom cognitive rehabilitation once (EA:30?min, CCR:30?min) a day, 3?days per week (excluding Saturday and Sunday) for 8?weeks. The primary outcome will be an improvement in cognitive function assessed using the Korean version of the Alzheimer's Disease Assessment Scale-cognitive subscale. Scores for the Korean version of the Montreal Cognitive Assessment scale, Center for Epidemiological Studies Depression Scale, Korean Activities of Daily Living scale, Korean Instrumental Activities of Daily Living scale, and European Quality of Life Five Dimension Five Level Scale will be recorded as secondary outcome measures. All scores will be recorded at baseline (before intervention), 8?weeks after the first intervention (i.e., at the end of the intervention), and 12?weeks after completion of the intervention.DiscussionThe study is expected to provide preliminary evidence regarding the efficacy, safety, and usefulness of EA-CCR for the treatment of MCI.Trial registrationKorea Clinical Information Service, cris.nih.go.kr, KCT0003415 . Registered on 4 January 2019. Retrospectively registered, http://cris.nih.go.kr .

Dataset Information

Internet-based cognitive rehabilitation for WORking Cancer survivors (i-WORC): study protocol of a randomized controlled trial.

Background

Methods/ design

Discussion

Trial registration

Publications

Internet-based cognitive rehabilitation for WORking Cancer survivors (i-WORC): study protocol of a randomized controlled trial.

Similar Datasets

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