Dataset Information

PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial.

ABSTRACT:

Background

Social isolation potentiates the risk of death by cancer in the older cancer patient population. The PREDOMOS study investigates the impact of establishing a Program of Social intervention associated with techniques of Domotic and Remote assistance on the improvement of quality of life of older isolated patients, treated for locally advanced or metastatic cancer. This paper updates the pilot trial protocol.

Methods/design

The original protocol was published in Trials, accessible at https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1894-7 . This update reports on the eligibility criteria expansion and on the adjunction of a cost-utility analysis. We widened the eligible population to patients with locally advanced or metastatic cancer including malignant hemopathies (except acute myeloid leukemia) and to patients in the first and second lines of oncologic treatment. We restricted the inclusion to patients with a Mini Mental State Examination score strictly over 24. In addition to the secondary outcomes outlined in the protocol, a medico-economic analysis has been added to evaluate both the health benefits and costs of the two strategies and calculate the incremental cost-utility ratio of the innovative program assessed, compared to the standard practice.

Trial registration

ClinicalTrials.gov, NCT02829762 . Registered on 29 June 2016.

SUBMITTER: Couderc AL

PROVIDER: S-EPMC6334455 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial.

Couderc Anne-Laure AL Nouguerède Emilie E Baumstarck Karine K Loubière Sandrine S Le Caer Hervé H Guillem Olivier O Rousseau Frédérique F Greillier Laurent L Norguet-Monnereau Emmanuelle E Cecile Maud M Boulahssass Rabia R Le Caer Françoise F Tournier Sandrine S Butaud Chantal C Guillet Pierre P Nahon Sophie S Kirscher Sylvie S Diaz Nadine N Morando Claire C Villani Patrick P Auquier Pascal P Daumas Aurélie A

Trials 20190115 1

<h4>Background</h4>Social isolation potentiates the risk of death by cancer in the older cancer patient population. The PREDOMOS study investigates the impact of establishing a Program of Social intervention associated with techniques of Domotic and Remote assistance on the improvement of quality of life of older isolated patients, treated for locally advanced or metastatic cancer. This paper updates the pilot trial protocol.<h4>Methods/design</h4>The original protocol was published in Trials, a ...[more]

PMID: 30646923

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Project description:BackgroundCancer incidence and social isolation increase along with advanced age, and social isolation potentiates the relative risk of death by cancer. Once spotted, social isolation can be averted with the intervention of a multidisciplinary team. Techniques of automation and remote assistance have already demonstrated their positive impact on falls prevention and quality of life (QoL), though little is known about their impact on socially isolated elderly patients supported for cancer. The primary objective of the PREDOMOS study is to evaluate the impact of establishing a Program of Social intervention associated with techniques of Domotic and Remote assistance (PS-DR) on the improvement of QoL of elderly isolated patients, treated for locally advanced or metastatic cancer. The secondary objectives include treatment failure, tolerance, survival, and autonomy.Methods/designThis trial is a multicenter, prospective, randomized, placebo-controlled, open-label, two-parallel group study. The setting is 10 French oncogeriatric centers. Inclusion criteria are patients aged at least 70 years with a social isolation risk and a histological diagnosis of cancer, locally advanced or metastatic disease. The groups are (1) the control group, receiving usual care; (2) the experimental group, receiving usual care associating with monthly social assistance, domotic, and remote assistance. Participants are randomized in a 1:1 allocation ratio. Evaluation times involve inclusion (randomization) and follow-up (12 months). The primary endpoint is QoL at 3 months (via European Organization for Research and Treatment of Cancer (EORTC) QLQ C30); secondary endpoints are social isolation, time to treatment failure, toxicity, dose response-intensity, survival, autonomy, and QoL at 6 months. For the sample size, 320 individuals are required to obtain 90% power to detect a 10-point difference (standard deviation 25) in QoL score between the two groups (20% loss to follow-up patients expected).DiscussionThe randomized controlled design is the most appropriate design to demonstrate the efficacy of a new experimental strategy (Evidence-Based Medicine Working Group classification). National and international recommendations could be updated based on the findings of this study.Trial registrationClinicalTrials.gov, NCT02829762 . Registered on 29 June 2016.

Project description:IntroductionLoneliness and social isolation have been identified as significant public health concerns, but improving relationships and increasing social participation may improve health outcomes and quality of life. The aim of the Project About Loneliness and Social networks (PALS) study is to assess the effectiveness and cost-effectiveness of a guided social network intervention within a community setting among individuals experiencing loneliness and isolation and to understand implementation of Generating Engagement in Network Involvement (Genie) in the context of different organisations.Methods and analysisThe PALS trial will be a pragmatic, randomised controlled trial comparing participants receiving the Genie intervention to a wait-list control group. Eligible participants will be recruited from organisations working within a community setting: any adult identified as socially isolated or at-risk of loneliness and living in the community will be eligible. Genie will be delivered by trained facilitators recruited from community organisations. The primary outcome will be the difference in the SF-12 Mental Health composite scale score at 6-month follow-up between the intervention and control group using a mixed effects model (accounting for clustering within facilitators and organisation). Secondary outcomes will be loneliness, social isolation, well-being, physical health and engagement with new activities. The economic evaluation will use a cost-utility approach, and adopt a public sector perspective to include health-related resource use and costs incurred by other public services. Exploratory analysis will use a societal perspective, and explore broader measures of benefit (capability well-being). A qualitative process evaluation will explore organisational and environmental arrangements, as well as stakeholder and participant experiences of the study to understand the factors likely to influence future sustainability, implementation and scalability of using a social network intervention within this context.Ethics and disseminationThis study has received NHS ethical approval (REC reference: 18/SC/0245). The findings from PALS will be disseminated widely through peer-reviewed publications, conferences and workshops in collaboration with our community partners.Trial registration numberISRCTN19193075.

Project description:ObjectivesCurrent choice models in healthcare (and beyond) can provide suboptimal predictions of healthcare users' decisions. One reason for such inaccuracy is that standard microeconomic theory assumes that decisions of healthcare users are made in a social vacuum. Healthcare choices, however, can in fact be (entirely) socially determined. To achieve more accurate choice predictions within healthcare and therefore better policy decisions, the social influences that affect healthcare user decision-making need to be identified and explicitly integrated into choice models. The purpose of this study is to develop a socially interdependent choice framework of healthcare user decision-making.DesignA mixed-methods approach will be used. A systematic literature review will be conducted that identifies the social influences on healthcare user decision-making. Based on the outcomes of a systematic literature review, an interview guide will be developed that assesses which, and how, social influences affect healthcare user decision-making in four different medical fields. This guide will be used during two exploratory focus groups to assess the engagement of participants and clarity of questions and probes. The refined interview guide will be used to conduct the semistructured interviews with healthcare professionals and users. These interviews will explore in detail which, and how, social influences affect healthcare user decision-making. Focus group and interview transcripts will be analysed iteratively using a constant comparative approach based on a mix of inductive and deductive coding. Based on the outcomes, a social influence independent choice framework for healthcare user decision-making will be drafted. Finally, the Delphi technique will be employed to achieve consensus about the final version of this choice framework.Ethics and disseminationThis study was approved by the Erasmus School of Health Policy and Management Research Ethics Review Committee (ESHPM, Rotterdam, The Netherlands; reference ETH2122-0666).

Project description:Physical activity during pregnancy assumes an important role in the health of both the pregnant and newborn. Given that physical activity tends to decrease throughout this period, it is essential to inform and encourage pregnant women to acquire healthy lifestyles, enabling them to improve their physical and psychological well-being. This study aims to evaluate the impact of an intervention program on pregnant, newborn, and gestation outcomes, by increasing physical activity levels during this important period of woman's life. This study will be conducted with 410 pregnant women in the first trimester. Participants will be recruited through the central hospital or community centers. Following consent and baseline data collection, pregnant women who do not have any medical or obstetric contraindication for physical exercise, will be assigned to the control or intervention groups. There will be 3 assessment periods: baseline (time 1-between the 7th and 10th week of gestation), after the intervention (time 2-between the 1st and 3rd day after delivery), and follow-up (time 3-1 month after delivery). The intervention group will have an intervention program, which comprises 2 terms: (1) teachers' training delivered by researchers and (2) intervention delivered to pregnant women by trained teachers, which consists in 3 weekly classes of physical exercise (45/50 min each). The control group will have the standard care that is usually provided by health professionals. The research has been approved by the Subcommittee on Ethics for the Life Sciences and Health of the University of Minho (id: SECVS 086/2015) and by the Ethics Committee for Health from the Central Hospital (id: 056/2014). There is a registration in clinical trials.gov, with the reference NCT03045237 (02/2017). This study has the potential to increase pregnant's physical activity levels and contribute to programs and policies developed to optimize lifestyles during pregnancy and with implications in newborn outcomes.

Project description:Postoperative delirium is common in the elderly and is associated with a significant increase in mortality, complications, length of hospital stay and admission in long care facility. Although several interventions have proved their effectiveness to prevent it, the Cochrane advises an assessment of multifaceted intervention using rigorous methodology based on randomized study design. Our purpose is to present the methodology and expected results of the CONFUCIUS trial, which aims to measure the impact of a multifaceted program on the prevention of postoperative delirium in elderly.Study design is a stepped wedge cluster randomized trial within 3 surgical wards of three French university hospitals. All patients aged 75 and older, and admitted for scheduled surgery will be included. The multifaceted program will be conducted by mobile geriatric team, including geriatric preoperative consultation, training of the surgical staff and implementation of the Hospital Elder Life Program, and morbidity and mortality conference related to delirium cases. The primary outcome is based on postoperative delirium rate within 7 days after surgery. This program is planned to be implemented along four successive time periods within all the surgical wards. Each one will be affected successively to the control arm and to the intervention arm of the trial and the order of program introduction within each surgical ward will be randomly assigned. Based on a 20% reduction of postoperative delirium rate (ICC = 0.25, ? = 0.05, ? = 0.1), three hundred sixty patients will be included i.e. thirty patients per service and per time period. Endpoints comparison between intervention and control arms of the trial will be performed by considering the cluster and time effects.Better prevention of delirium is expected from the multifaceted program, including a decrease of postoperative delirium, and its consequences (mortality, morbidity, postoperative complications and length of hospital stay) among elderly patients. This study should allow better diagnosis of delirium and strengthen the collaboration between surgical and mobile geriatric teams. Should the program have a substantial impact on the prevention of postoperative delirium in elderly, it could be extended to other facilities.ClinicalTrials.gov: NCT01316965.

Project description:BackgroundThe limited or uncertain access to adequate food in elderly people includes not only economic restrictions but also inability of food utilization due to functional or cognitive impairment, health problems, and illiteracy.ObjectiveThe aim of this work is to present the protocol of the randomized controlled trial Saúde.Come Senior, an educational and motivational television (TV)-based intervention to promote healthy lifestyles and decrease food insecurity in elderly people.MethodsA randomized controlled study will be conducted in subjects aged 60 years and older with food insecurity, identified at 17 primary care centers in the Lisboa e Vale do Tejo health region in Lisbon, Portugal. The primary outcome will be the changes in participants' food insecurity score (evaluated by the Household Food Insecurity Scale) at 3 months. Change in other outcomes will be assessed (dietary habits, nutritional status, physical activity, health status, and clinical outcomes). Subjects will be followed over 6 months; the intervention will last 3 months. Data collection will be performed at 3 different time points (baseline, end of intervention at 3 months, and follow-up at 6 months). The intervention is based on an interactive TV app with an educational and motivational program specifically developed for the elderly that has weekly themes and includes daily content in video format: (1) nutrition and diet tips for healthy eating, (2) healthy, easy to cook and low-cost recipes, and (3) physical exercise programs. Furthermore, brief reminders on health behaviors will also be broadcasted through the TV app. The total duration of the study will be 6 months. The intervention is considered to be effective and meaningful if 50% of the individuals in the experimental group have a decrease of 1 point in the food insecurity score, all the remaining being unchanged. We expect to include and randomize 282 (141 experimental and 141 control) elderly with food insecurity. We will recruit a total of 1,128 subjects considering that 50% of the target individuals are food insecure (based on INFOFAMÍLIA Survey) (567) and about 50% of those will adhere to the study (282).ResultsThe randomized controlled trial with the 12-week home-based intervention with a comprehensive program on healthy eating and physical activity delivery is planned to start recruiting participants at the end of 2017.ConclusionsThis study will assess the efficacy of this innovative tool (Saúde.Come Senior) for disseminating relevant health information, modifying behaviors, and decreasing food insecurity in an easy, low-cost, and massive way.

Project description:BackgroundSedentary lifestyles, poor nutritional choices, inadequate sleep, risky substance use, limited social connections, and high stress contribute to the growing prevalence of chronic diseases. Lifestyle medicine, emphasizing therapeutic lifestyle changes for prevention and treatment, has demonstrated effectiveness but remains underutilized in clinical settings. The Complete Lifestyle Medicine Intervention Program-Ontario (CLIP-ON) was developed to educate the rural population of Northern Ontario in lifestyle medicine to improve health outcomes and engagement.ObjectiveThis study evaluates the implementation and effectiveness of the CLIP-ON program for patients with chronic diseases in the Parry Sound area, focusing on lifestyle behaviors, health outcomes, enrollment, retention rates, and interdisciplinary team engagement.MethodsThis observational cohort study guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) includes pre- and postintervention assessments from participants and health care providers. A hybrid type II mixed methods design evaluates the intervention's effectiveness and implementation process in real-world settings through quantitative and qualitative data collection. CLIP-ON is tailored to the residents of the Parry Sound catchment area in Northern Ontario. Participants (≥18 years old) with chronic conditions such as prediabetes, type II diabetes, systemic hypertension, cardiovascular vascular disease, dyslipidemia, or high BMI (≥25) will be recruited through self-referral or provider referral. Approximately 10 participants per cohort will be enrolled in the CLIP-ON program, consisting of 22 weeks of weekly group sessions and monthly individual consultations with physicians, health coaches, kinesiologists, and registered dieticians either in person or through a web-based platform. CLIP-ON will cover the 6 pillars of lifestyle medicine through 14 group sessions followed by an 8-week supervised exercise program. Anthropometric and cardiometabolic variables will be measured before and after the program. Participants will be surveyed on lifestyle habits, wellness, perceived barriers, and program satisfaction at 3 and 6 months. Focus groups and dropout interviews with participants (n=10 per cohort) and providers (n=6 per cohort) will guide program adaptations. Quantitative and qualitative data collected at baseline and follow-up will assess the program's implementation and identify barriers and opportunities for improvement.ResultsThis study was approved by the Laurentian University Research Ethics Board (6021397) on July 6, 2023. The first cohort was enrolled in late 2023 and is still under evaluation. The second cohort began in mid-2024, and data collection is currently underway. A mixed methods analysis will be used at enrollment, program completion (22 weeks), and follow-up (6 months after program completion). Focus groups assessing the program's effectiveness and implementation will take place after the 22-week intervention. Data will be analyzed in early 2025.ConclusionsThis protocol provides insights into the implementation of this lifestyle medicine program and its impact on participants' health. The findings will guide future advancements and establish a scalable model for other communities.Trial registrationClinicalTrials.gov NCT06192251; https://clinicaltrials.gov/study/NCT06192251.International registered report identifier (irrid)DERR1-10.2196/59179.

Dataset Information

PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial.

Background

Methods/design

Trial registration

Publications

PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial.

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