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Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol.

ABSTRACT: BACKGROUND:Cancer has a lot of consequences on patients' quality of life (such as cancer-related fatigue (CRF), sleep difficulties and emotional distress) and on patients' partners and their relationship, such as distress and communication difficulties. These consequences are undertreated, and interventions based on hypnosis often focus on breast cancer patients only. This paper describes the study protocol of a longitudinal randomized controlled trial aiming to assess the efficacy of an 8-week intervention combining hypnosis and self-care to improve cancer patients' CRF, sleep and emotional distress and to indirectly improve their partners' distress. METHODS:A power analysis required a total sample of 88 patients. To test the efficacy of the intervention, results of the experimental group receiving the intervention will be compared to those of the control group. Data will be collected by questionnaires, relaxation tasks, an attentional bias task, and everyday life assessments measured at four different times: 1.) before inclusion in the study (baseline); 2.) after the intervention; and 3.) at 4- and 12-month follow-up. Partners' symptoms will also be evaluated with questionnaires at the same measurement times. DISCUSSION:There is a growing interest in alternative approaches (such as hypnosis) in addition to standard therapies in oncology settings. The results of this study should be useful for improving knowledge about long-term efficacy of hypnosis-based group interventions for CRF, sleep and distress among all types of cancer patients and their partners, and to better understand the mechanisms of emotional regulation in cancer patients through the attentional bias task. TRIAL REGISTRATION:ClinicalTrials.gov (NCT03144154). Retrospectively registered on the 1st of May, 2017.

SUBMITTER: Gregoire C

PROVIDER: S-EPMC6238378 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol.

Grégoire Charlotte C Faymonville Marie-Elisabeth ME Vanhaudenhuyse Audrey A Charland-Verville Vanessa V Jerusalem Guy G Bragard Isabelle I

BMC cancer 20181115 1

<h4>Background</h4>Cancer has a lot of consequences on patients' quality of life (such as cancer-related fatigue (CRF), sleep difficulties and emotional distress) and on patients' partners and their relationship, such as distress and communication difficulties. These consequences are undertreated, and interventions based on hypnosis often focus on breast cancer patients only. This paper describes the study protocol of a longitudinal randomized controlled trial aiming to assess the efficacy of an ...[more]

PMID: 30442120

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Project description:BACKGROUND:Chronic heart failure (CHF) is a public health priority. Its age-standardized prevalence has increased over the past decade. A major challenge for the management of CHF is to promote long-term adherence to self-care behaviors without overtaxing available health care resources. Counseling by multidisciplinary health care teams helps to improve adherence to self-care behaviors and to reduce the rate of death and hospitalization. In the absence of intervention, adherence to self-care is below recommended standards. OBJECTIVE:This trial aims to establish and evaluate a Canadian e-platform that will provide a core, standardized protocol of behavioral counseling and education to facilitate long-term adherence to self-care among patients with CHF. METHODS:Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure (CHF-CePPORT) is a multi-site, double blind, randomized controlled trial with a 2 parallel-group (e-Counseling + Usual Care vs e-Info Control + Usual Care) by 3 assessments (baseline, 4-, and 12-month) design. We will identify subjects with New York Heart Association Class II or III systolic heart failure from collaborating CHF clinics and then recruit them (n=278) by phone. Subjects will be randomized in blocks within each site (Toronto, Montreal, and Vancouver). The primary outcome will be improved quality of life, defined as an increased number of subjects with an improvement of ?5 points on the summary score of the Kansas City Cardiomyopathy Questionnaire. We will also assess the following secondary outcomes: (1) diet habits, depression, anxiety, smoking history, stress level, and readiness for change using self-report questionnaires, (2) physical activity level, current smoking status, and vagal-heart rate modulation by physiological tests, and (3) exercise capacity, prognostic indicators of cardiovascular functioning, and medication adherence through medical chart review. The primary outcome will be analyzed using generalized estimation equations with repeated measures on an intention-to-treat basis. Secondary outcomes will be analyzed using repeated-measures linear mixed models with a random effects intercept. All significant main effects or interactions in the statistical models will be followed up with post hoc contrasts using a Bonferroni correction with a 2-sided statistical significance criterion of P<.05. RESULTS:This 3.5-year, proof-of-principle trial will establish the e-infrastructure for a pan-Canadian e-platform for CHF that is comprised of a standardized, evidence-based protocol of e-Counseling. CONCLUSIONS:CHF-CePPORT is designed to improve long-term adherence to self-care behaviors and quality of life among patients with CHF. It will demonstrate a distinct Canadian initiative to build capacity for preventive eHealth services for patients with CHF. TRIAL REGISTRATION:ClinicalTrials.gov NCT01864369; http://clinicaltrials.gov/ct2/show/NCT01864369 (Archived by WebCite at http://www.webcitation.org/6Iiv6so7E).

Project description:BackgroundThe financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes.Methods/designThe study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status).DiscussionPiloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of efficacy to inform the design of a future full-scale randomized controlled trial of the 'Living well with asthma' website.Trial registrationThis trial is registered with Current Controlled Trials ISRCTN78556552 on 18/06/13.

Project description:BACKGROUND:New technologies, internet accessibility, social media, and increased smartphone ownership provide new opportunities for health researchers to communicate and engage target audiences. An innovative burn prevention intervention was developed using these channels. OBJECTIVE:The aim of this study was to evaluate the efficacy of Cool Runnings, an app-based intervention to increase knowledge of childhood burn risk (specifically hot beverage scalds) and correct burn first aid among mothers of young children. METHODS:This was a 2-group, parallel, single-blinded randomized controlled trial (RCT). Participants were women aged 18 years and above, living in Queensland, Australia, with at least 1 child aged 5-12 months at time of enrollment. The primary outcome measures were change in knowledge about risk of burns and correct burn first aid assessed via 2 methods: (1) overall score and (2) categorized as adequate (score=4) versus inadequate (score<4). Efficacy of gamification techniques was also assessed. RESULTS:In total, 498 participants were recruited via social media and enrolled. At the 6-month follow-up, 244 participants completed the posttest questionnaire. Attrition rates in both groups were similar. Participants who remained in the study did not differ from those lost to follow-up on any characteristics except education level. Although similar at baseline, intervention group participants achieved significantly greater improvement in overall knowledge posttest than control group participants on both primary outcome measures (overall knowledge intervention: mean [SD] of overall knowledge 2.68 [SD 1.00] for intervention vs 2.13 [SD 1.03] for control; 20.7% [25/121] adequate in intervention vs 7.3% [2/123] in control). Consequently, the number needed to treat was 7.46. Logistic regression showed participants exposed to the highest level of disadvantage had 7.3 times higher odds of improved overall knowledge scores than participants in other levels of disadvantage. There were also significant correlations between gamification techniques and knowledge change (P<.001). In addition, odds of knowledge improvement between baseline and 6-month follow-up was higher in participants with low-moderate app activity compared with no app activity (odds ratio [OR] 8.59, 95% CI 2.9-25.02) and much higher in participants with high app activity (OR 18.26, 95% CI 7.1-46.8). CONCLUSIONS:Despite substantial loss to follow-up, this RCT demonstrates the Cool Runnings app was an effective intervention for improving knowledge about risks of hot beverage scalds and burn first aid in mothers of young children. The benefits of combining gamification elements in the intervention were also highlighted. Given the low cost and large reach of smartphone apps to deliver content to and engage with targeted populations, the results from this RCT provide important information on how smartphone apps can be used for widespread injury prevention campaigns and public health campaigns generally. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12616000019404; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369745&showOriginal=true&isReview=true (Archived by WebCite at http://www.webcitation.org/72b1E8gTW).

Project description:BackgroundObesity affects 25% of the UK adult population but modest weight loss can reduce the incidence of obesity-related chronic disease. Some effective weight loss treatments exist but there is no nationally available National Health Service (NHS) treatment service, and general practitioners (GPs) rarely discuss weight management with patients or support behavior change. Evidence shows that commercial weight management services, that most primary care trusts have 'on prescription', are more effective than primary care treatment.Methods/designWe propose a controlled trial where patients will be randomized to receive either the offer of help by referral to a weight management service and follow-up to assess progress, or advice to lose weight on medical grounds. The primary outcome will be weight change at 12-months. Other questions are: what actions do people take to manage their weight in response to the two GP intervention types? How do obese patients feel about GPs opportunistically discussing weight management and how does this vary by intervention type? How do GPs feel about raising the issue opportunistically and giving the two types of brief intervention? What is the cost per kg/m2 lost for each intervention? Research assistants visiting GP practices in England (n?=?60) would objectively measure weight and height prior to GP consultations and randomize willing patients (body mass index 30+, excess body fat, 18+ years) using sealed envelopes. Full recruitment (n?=?1824) is feasible in 46 weeks, requiring six sessions of advice-giving per GP. Participants will be contacted at 3 months (postintervention) via telephone to identify actions they have taken to manage their weight. We will book appointments for participants to be seen at their GP practice for a 12-month follow-up.DiscussionTrial results could make the case for brief interventions for obese people consulting their GP and introduce widespread simple treatments akin to the NHS Stop Smoking Service. Likewise, the intervention could be introduced in the Quality and Outcomes Framework and influence practice worldwide.Trial registrationCurrent Controlled Trials ISRCTN26563137.

Project description:BackgroundMy Diabetes Care (MDC) is a multi-faceted intervention embedded within an established patient portal, My Health at Vanderbilt. MDC is designed to help patients better understand their diabetes health data and support self-care. MDC uses infographics to visualize and summarize patients' diabetes health data, incorporates motivational strategies, provides literacy-level appropriate educational resources, and links to a diabetes online patient support community and diabetes news feeds.ObjectiveThis study aims to evaluate the effects of MDC on patient activation in adult patients with type 2 diabetes mellitus. Moreover, we plan to assess secondary outcomes, including system use and usability, and the effects of MDC on cognitive and behavioral outcomes (eg, self-care and self-efficacy).MethodsWe are conducting a 6-month, 2-arm, parallel-design, pragmatic pilot randomized controlled trial of the effect of MDC on patient activation. Adult patients with type 2 diabetes mellitus are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible for the study if they are currently being treated with at least one diabetes medication, are able to speak and read in English, are 21 years or older, and have an existing My Health at Vanderbilt account and reliable access to a desktop or laptop computer with internet access. We exclude patients living in long-term care facilities, patients with known cognitive deficits or severe visual impairment, and patients currently participating in any other diabetes-related research study. Participants are randomly assigned to MDC or usual care. We collect self-reported survey data, including the Patient Activation Measure (R) at baseline, 3 months, and 6 months. We will use mixed-effects regression models to estimate potentially time-varying intervention effects while adjusting for the baseline measure of the outcome. The mixed-effects model will use fixed effects for patient-level characteristics and random effects for health care provider variables (eg, primary care physicians).ResultsThis study is ongoing. Recruitment was closed in May 2020; 270 patients were randomized. Of those randomized, most (214/267, 80.1%) were non-Hispanic White, and 13.1% (35/267) were non-Hispanic Black, 43.7% (118/270) reported being 65 years or older, and 33.6% (90/268) reported limited health literacy. We obtained at least 95.6% (258/270) completion among participants through the 3-month follow-up assessment.ConclusionsThis randomized controlled trial will be one of the first to evaluate a patient-facing diabetes digital health intervention delivered via a patient portal. By embedding MDC into Epic's MyChart platform with more than 127 million patient records, our intervention is directly integrated into routine care, highly scalable, and sustainable. Our findings and evolving patient portal functionality will inform the continued development of MDC to best meet users' needs and a larger trial focused on the impact of MDC on clinical end points.Trial registrationClinicalTrials.gov NCT03947333; https://clinicaltrials.gov/ct2/show/NCT03947333.International registered report identifier (irrid)DERR1-10.2196/25955.

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Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol.

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Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol.

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