ClinicalTrials.gov
ClinicalTrials.gov Menu

Multicenter Prospective Cohort of Informal Caregivers in Burgundy and Franche-Comté (ICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02626377
Recruitment Status : Recruiting
First Posted : December 10, 2015
Last Update Posted : October 12, 2017
Sponsor:
Collaborators:
Methodological and quality of life unit in oncology (CHRU de Besançon)
University of Franche-Comté
University of Burgundy
Pôle de Gérontologie Interrégional Bourgogne et Franche-Comté
CARSAT Bourgogne et Franche-Comté
CCAS of Dijon
CCAS of Besançon
CCAS of Montbéliard
Burgundy Regional Council
Franche-Comté Regional Council
The Municipality of Besançon
The Municipality of Dijon
General Council of the Doubs
General Council of the Territoire de Belfort
Collectif Inter Associatif Sur la Sante Bourgogne
Union Régionale Interfédérale des Œuvres et Organismes Privés Sanitaires Bourgogne
Association Gérontopôle Pierre Pfitzenmeyer
Pôle de compétitivité Vitagora Goût-Nutrition-Santé
Caisse Nationale d’Assurance Vieillesse des Travailleurs Salariés (CNAVTS)
Sheerbrooke Gérontopôle
France Alzheimer Côte-d’Or
Institut Régional de Vieillissement (IRV)
Novartis Pharmaceuticals
Roche Foundation
Ligue contre le cancer, France
National Cancer Institute, France
Quality of life and cancer clinical research platform
National Research Agency, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:

Medical progress and modification of lifestyles have prolonged life expectancy, despite the development of chronic diseases. The support and care are often provided by a network of informal caregivers composed of family, friends, and neighbors. They became essential to help maintening the elderly persons to live at home. It has been demonstrated that the importance and the diversity of informal tasks may jeopardize their own physical, mental and social well-being.

The aim of the Informal Carers of Elderly Cohort is to define, through a longitudinal study of their life course, the profiles of caregivers of patients with a diagnosis of one of the following diseases: cancer (breast, prostate, colon-rectum), neuro-degenerative diseases (Parkinson's disease, Alzheimer's and similar diseases), neuro-vascular diseases (Cerebrovascular Accident (CVA)), Age-related Macular Degeneration(AMD) and heart disease (heart failure), aged ≥ 60 years old and living in Burgundy or Franche-Comte. 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 and evaluate the implementation of a pragmatic social action to help informal caregivers through a randomized intervention trial nested in the cohort.

Thanks to an analytical and longitudinal definition of the profiles of informal caregivers, this study could gather precise information on their life courses and their health trajectory by identifying the consequences associated with the concept of their role of aid in care. In addition, the randomized intervention trial will explore the efficacy, in terms of quality of life, and efficiency of a social action to support the caregivers. These data will allow 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 and to give an impulse for new healthcare policies.


Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Prostate Cancer Alzheimer Disease Age-related Macular Degeneration Parkinson Disease Cardiac Disease Ischemic Stroke Hemorrhagic Stroke Behavioral: Support provided by social worker Other: Information booklet receipt Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7604 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Multicenter Prospective Cohort of Informal Caregivers in Burgundy-Franche-Comté. ICE Cohort (Informal Caregivers of Elderly)
Study Start Date : October 2015
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Interventional arm
'Support provided by social worker'
Behavioral: Support provided by social worker
Caregivers randomized in intervention arm will receive an information booklet (which informs about existing structures and actions) and will receive support provided by a social worker schedule every 6 months during two years. The support duration will be one hour and will be defined as two parts: administration of the LASA questionnaire, and a standardized semi directive interview to assess needs.

Other: Information booklet receipt
Caregivers will only receive an information booklet (which informs about existing structures and actions)

Non-interventional arm
'Information booklet receipt'
Other: Information booklet receipt
Caregivers will only receive an information booklet (which informs about existing structures and actions)




Primary Outcome Measures :
  1. (Interventional Study) Comparison of caregivers' HRQoL according to the allocated intervention by randomization based on summaries score the MOS SF36 [ Time Frame: One year after randomization ]
    The main objective of the randomized study is to compare the Health Related Quality of Life based on summaries score the MOS SF36 one year after randomization according to the allocated intervention.

  2. (Observational study) Changes in HRQoL of patients' caregivers using the MOS SF36 questionnaire [ Time Frame: At 1, 3, 6, 9, 12, 15,18, 21, 24, 30, 36, 42, 48, 54 and 60 months post-randomization ]
    The main objective of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their HRQoL using the MOS SF36 questionnaire

  3. (Observational study) Changes in HRQoL of cancer patients' caregivers using the CarGoQoL questionnaire [ Time Frame: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization ]
    the aim of the observational study is to define the longitudinal profiles of cancer patient's caregivers according to the evaluation of their HRQoL using the CarGoQoL questionnaire

  4. (Observational study) Changes in the coping strategies of patients' caregivers using the Borteyrou, Rascle and Truchot Questionnaire [ Time Frame: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization ]
    The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their coping strategies using the Borteyrou, Rascle and Truchot Questionnaire.

  5. (Observational study) Changes in feelings of anxiety and depression of patients' caregivers according to the HADs questionnaire [ Time Frame: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization ]
    The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their anxiety and depression according to the HADs questionnaire.

  6. (Observational study) Changes in social support of patients' caregivers using the SSQ6 questionnaire [ Time Frame: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization ]
    The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their social support using the SSQ6 questionnaire.

  7. (Observational study) Changes in burden of patients' caregivers using the Zarit burden inventory [ Time Frame: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization ]
    The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation burden using the Zarit burden inventory


Secondary Outcome Measures :
  1. (Interventional Study) Comparison of caregivers' HRQoL according to the intervention allocated by randomization based on summaries score the MOS SF36 [ Time Frame: Two years after randomization ]
    To compare the Health Related Quality of Life based on summaries score the MOS SF36 two years after randomization according to the allocated intervention.

  2. (Interventional Study) Changes in HRQoL of patients' caregivers according to the allocated intervention using the MOS SF36 questionnaire [ Time Frame: At 1, 3, 6, 9, 12, 15,18, 21, 24, 30, 36, 42, 48, 54 and 60 months post-randomization ]
    To compare longitudinally all dimensions of HRQoL using the MOS SF36 questionnaire according to the allocated intervention.

  3. (Interventional Study) Changes in HRQoL of cancer patients' caregivers according to the allocated intervention using the CarGoQol questionnaire [ Time Frame: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization ]
    To compare longitudinally the HRQoL of cancer patients' caregivers, according to the allocated intervention, using the CarGoQol questionnaire.

  4. (Interventionnal Study) Changes in the coping strategies of patients' caregivers according to the allocated intervention using the Borteyrou, Rascle and Truchot Questionnaire [ Time Frame: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization ]
    To compare longitudinally the coping strategies of patients' caregivers, according to the allocated intervention, using the Borteyrou, Rascle and Truchot Questionnaire.

  5. (Interventional Study) Changes in feelings of anxiety and depression of patients' caregivers according to the allocated intervention using the HADs Questionnaire [ Time Frame: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization ]
    To compare longitudinally the feelings of anxiety and depression of patients' caregivers, according to the allocated intervention, using the HADs Questionnaire.

  6. (Interventional Study) Changes in social supports of patients' caregivers according to the allocated intervention using the SSQ6 questionnaire [ Time Frame: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization ]
    To compare longitudinally the social support of patients' caregivers, according to the allocated intervention, using the SSQ6 questionnaire.

  7. (Interventional Study) Changes in burden of patients' caregivers according to the allocated intervention using the Zarit burden inventory [ Time Frame: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization ]
    To compare longitudinally the burden of patients' caregivers, according to the allocated intervention, using the Zarit burden inventory.

  8. (Interventional study) Efficiency of the intervention of a social worker for caregivers using a cost-utility analysis [ Time Frame: At 1, 3, 6,9,12,15,18 and 24 months post-randomization ]
    The efficiency of the intervention of a social worker for caregivers will be assessed using a cost-utility analysis, aiming at comparing in terms of costs and utility the intervention versus the absence of intervention of a social worker

  9. (Observational study) Changes in the caregivers/patients' relationship using a qualitative approach (semi-structure interview) [ Time Frame: At 1,6,12,18,24,30,36,42,48,54 and 60 months post randomization ]
    to evaluate the caregivers/patients' relationship and the changes of the relationship using a qualitative approach (semi-structure interview), to describe the specificity of the care and of the help from people carrying diseases with behavioral disorders (Alzheimer-type dementia in particular)

  10. (Observational study) Changes in the role of caregiver due to a situation generating a rupture (entry into an institution or death, disease remission) using a qualitative approach (semi-structure interview) [ Time Frame: At 1,6,12,18,24,30,36,42,48,54 and 60 months post randomization ]
    to study the situations generating a rupture in their role of caregiver (entry into an institution or death, disease remission) using a qualitative approach (semi-structure interview)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patient :

Inclusion Criteria:

  • To be able to identify a principal caregiver via a specific questionnaire (if the patient is unable to identify himself his caregiver due to the disease, a self-designation form as a principal caregiver will be allow and propose)
  • to accept to complete the questionnaire to designate the principal caregiver;
  • To live in either Burgundy-Franche-Comte county;
  • have been recently diagnosed at hospital or in private-sector for the following diseases: Local or metastatic cancer diagnosed less than 6 month (breast cancer-hormone sensitive- in first line chemotherapy treatment, hormone-sensitive prostate cancer or in metastatic recurrence after 3 years of remission, considered as a new case, colorectal cancer in first line chemotherapy treatment), a neuro-degenerative disease (Parkinson disease diagnosed less than 7 years, Alzheimer disease and similar diseases diagnosed less than 12 months and /or with a Mini Mental State Examination (MMSE)<24 and >10 (performed less than 3 mois)), Age-related Macular Degeneration,( geographic atrophy or neovascular, diagnosed less than 12 month with an acuity range between 2 and 6/10e, be at least 65 years old and have received less than 3 sessions of intravitreal injections (IVT)), cardiac disease (heart failure diagnosed less than 3 months), neuro-vascular disease (ischemic or hemorrhagic stroke with clinical evidence of post stroke lesions upper than 24 hours, diagnosed less than 6 months and with a Rankin's score inferior or equal to 2).

Exclusion Criteria:

  • previously diagnosed with another targeted disease and/or living in retirement home could not be included

Caregiver

Inclusion Criteria:

  • to be a member of the patient's social environment (family, friend and neighbor);
  • to be identify by the patient as the "principal caregiver" based on the designation questionnaire or to have complete the self-designation form as a principal caregiver;
  • ≥ 18 years old;
  • not be an employee of a healthcare organization;
  • living in Burgundy-Franche-Comte;
  • to be able to complete questionnaires,

Exclusion Criteria:

- to be under guardianship, curatorship or under the protection of justice


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626377


Contacts
Contact: Clémence QUIBEL 0380371372 ext +33 cquibel.pgi@gmail.com
Contact: Astrid POZET 0370632179 ext +33 apozet@chu-besancon.fr

Locations
France
CHRU de Besançon Recruiting
Besançon, France, 25030
Contact: Morgane CHOTARD    0370632183 ext +33    mchotard@chu-besancon.fr   
Contact: Cécile ROLLER    0370632178    croller@chu-besancon.fr   
Centre Georges François Leclerc Recruiting
Dijon, France, 21079
Contact: Valérie BOYEAU    0345348089 ext +33    VBoyeau@cgfl.fr   
Contact: Geneviève LAPORTE    0345348089 ext +33    GLaporte@cgfl.fr   
CHU de DIJON Recruiting
Dijon, France, 21079
Contact: Ophélie HOCHART    0380293592 ext +33    ophelie.hochart@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Methodological and quality of life unit in oncology (CHRU de Besançon)
University of Franche-Comté
University of Burgundy
Pôle de Gérontologie Interrégional Bourgogne et Franche-Comté
CARSAT Bourgogne et Franche-Comté
CCAS of Dijon
CCAS of Besançon
CCAS of Montbéliard
Burgundy Regional Council
Franche-Comté Regional Council
The Municipality of Besançon
The Municipality of Dijon
General Council of the Doubs
General Council of the Territoire de Belfort
Collectif Inter Associatif Sur la Sante Bourgogne
Union Régionale Interfédérale des Œuvres et Organismes Privés Sanitaires Bourgogne
Association Gérontopôle Pierre Pfitzenmeyer
Pôle de compétitivité Vitagora Goût-Nutrition-Santé
Caisse Nationale d’Assurance Vieillesse des Travailleurs Salariés (CNAVTS)
Sheerbrooke Gérontopôle
France Alzheimer Côte-d’Or
Institut Régional de Vieillissement (IRV)
Novartis Pharmaceuticals
Roche Foundation
Ligue contre le cancer, France
National Cancer Institute, France
Quality of life and cancer clinical research platform
National Research Agency, France
Investigators
Principal Investigator: Virginie NERICH, Dr Pôle Pharmaceutique CHU de Besançon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02626377     History of Changes
Other Study ID Numbers: P/2014/231
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

Keywords provided by Centre Hospitalier Universitaire de Besancon:
Informal caregivers
Elderly
Quality of life
Cost effectiveness
Cohort study
Randomized study

Additional relevant MeSH terms:
Stroke
Colorectal Neoplasms
Parkinson Disease
Alzheimer Disease
Macular Degeneration
Heart Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases
Dementia
Tauopathies
Neurocognitive Disorders
Mental Disorders