title: Evaluation of efficacy and efficiency of a pragmatic intervention by a social worker to support informal caregivers of elderly patients (The ICE Study): study protocol for a randomized controlled trial.
abstract: Medical progress and the lifestyle modification have prolonged life expectancy, despite the development of chronic diseases. Support and care for older subjects are often provided by a network of informal caregivers composed of family, friends and neighbors, who are essential in helping older persons to continue living at home. It has been shown that the extent and diversity of informal tasks may jeopardize the physical, mental and social wellbeing of caregivers.
  
  
  
  The aim of the Informal Carers of Elderly cohort is to define, through a longitudinal study, profiles of caregivers of older patients with a diagnosis of one of the following diseases: cancer (breast, prostate, colorectal), neurodegenerative diseases (Parkinson's disease, Alzheimer's disease and similar diseases), neurovascular diseases (stroke), sensory diseases (age-related macular degeneration (AMD)) and heart disease (heart failure). Patients must be at least 60 years old and living in the region of Burgundy-Franche-Comte (France). By following the different phases of the caregiving relationship from the announcement of the diagnosis, it will be possible to assess the quality of life of caregivers, coping strategies, levels of anxiety and depression, social support and the extent of their burden. We will also evaluate the efficacy and efficiency of the implementation of a pragmatic intervention by a social worker to help informal caregivers, through a randomized interventional trial nested in the cohort. Qualitative approaches aimed at studying the caregiver/patient relationship, and situations leading to breakdown of the caregiver relationship will be also undertaken.
  
  
  
  Through an analytical and longitudinal definition of profiles of informal caregivers, this study will gather detailed information on their life courses and their health trajectory by identifying consequences associated with the concept of their role as carers. In addition, the randomized interventional trial will explore the relevance of the implementation of a supportive intervention by a social worker to help caregivers. These data will help to identify strategies that could be used to improve the existing sources of aid and to propose new approaches to help caregivers. This study will provide the opportunity to identify the most relevant means of support adapted to caregivers, and provide an impulse for new health care policies.
  
  
  
  ClinicalTrials.gov Identifier: NCT02626377 . Retrospectively registered on 9 December 2015. Protocol date/version: 23 October 2014/version 2.
authors.affiliation: Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Institut National de la Santé et de la Recherche Médicale UMR 1098, Besançon, France. apozet@chu-besancon.fr.|Methodology and Quality of Life in Oncology Unit, University Hospital Jean Minjoz, Boulevard Fleming, 25030, Besançon, France. apozet@chu-besancon.fr.
authors.forename: Astrid
authors.identifier: 0000-0003-4371-1112
authors.initials: A
authors.lastname: Pozet
authors.affiliation: INSERM U866 Epidémiologie et Recherche Clinique en Oncologie Digestive, University of Burgundy, Dijon, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Lejeune
authors.affiliation: UFR Sciences du Langage de l'Homme et de la Société, University of Franche-Comté, Besançon, France.
authors.forename: Magalie
authors.initials: M
authors.lastname: Bonnet
authors.affiliation: EA 4184, Centre Georges François Leclerc, Dijon, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Dabakuyo
authors.affiliation: Centre Georges Chevrier, UMR CNRS 7366, UFR Sciences Humaines et Sociales, Dijon, France.
authors.forename: Michèle
authors.initials: M
authors.lastname: Dion
authors.affiliation: EA 4184, Faculty of Pharmacy, University of Burgundy, Dijon, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Fagnoni
authors.affiliation: Centre Georges Chevrier, UMR CNRS 7366, UFR Sciences Humaines et Sociales, Dijon, France.
authors.forename: Maryse
authors.initials: M
authors.lastname: Gaimard
authors.affiliation: Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Institut National de la Santé et de la Recherche Médicale UMR 1098, Besançon, France.
authors.forename: Geneviève
authors.initials: G
authors.lastname: Imbert
authors.affiliation: INSERM U1098. Interaction Hôte-Greffon et Ingénierie Cellulaire et Génique, Besançon, France.
authors.forename: Virginie
authors.initials: V
authors.lastname: Nerich
authors.affiliation: Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Institut National de la Santé et de la Recherche Médicale UMR 1098, Besançon, France.
authors.forename: Audrey
authors.initials: A
authors.lastname: Foubert
authors.affiliation: Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Institut National de la Santé et de la Recherche Médicale UMR 1098, Besançon, France.
authors.forename: Morgane
authors.initials: M
authors.lastname: Chotard
authors.affiliation: Pôle de Gérontologie Interrégional Bourgogne et Franche-Comté (PGI), Besançon, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Bonin
authors.affiliation: Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Institut National de la Santé et de la Recherche Médicale UMR 1098, Besançon, France.|The French National Platform Quality of Life and Cancer, Besançon, France.
authors.forename: Amélie
authors.initials: A
authors.lastname: Anota
authors.affiliation: Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Institut National de la Santé et de la Recherche Médicale UMR 1098, Besançon, France.|The French National Platform Quality of Life and Cancer, Besançon, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000223:Adaptation, Psychological; D000367:Age Factors; D000375:Aging; D001007:Anxiety / Q000175:diagnosis / Q000209:etiology / Q000523:psychology; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D017028:Caregivers / Q000523:psychology; D057186:Comparative Effectiveness Research; D017281:Cost of Illness; D003863:Depression / Q000175:diagnosis / Q000209:etiology / Q000523:psychology; D005602:France; D006304:Health Status; D057187:Independent Living; D008137:Longitudinal Studies; D009369:Neoplasms / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D019636:Neurodegenerative Diseases / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D011446:Prospective Studies; D036301:Qualitative Research; D011788:Quality of Life; D012107:Research Design; D012944:Social Support; D000068217:Social Workers; D013997:Time Factors; D016032:Randomized Controlled Trials as Topic; D064792:Pragmatic Clinical Trials as Topic
keywords: Cancer; Chronic disease; Cost-utility; Elderly; Health-related quality of life; Informal caregivers; Longitudinal cohort study; Randomized study