Clinical trial NCT02626377: Multicenter Prospective Cohort of Informal Caregivers in Burgundy and Franche-Comté
Official title: Multicenter Prospective Cohort of Informal Caregivers in Burgundy-Franche-Comté. ICE Cohort (Informal Caregivers of Elderly)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Prostate Cancer
Alzheimer Disease
Age-related Macular Degeneration
Parkinson Disease
Cardiac Disease
Ischemic Stroke
Hemorrhagic Stroke
Keywords: Informal caregivers
Elderly
Quality of life
Cost effectiveness
Cohort study
Randomized study
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Methodological and quality of life unit in oncology (CHRU de Besançon)
name: University of Franche-Comté
name: University of Burgundy
name: Pôle de Gérontologie Interrégional Bourgogne et Franche-Comté
name: CARSAT Bourgogne et Franche-Comté
name: CCAS of Dijon
name: CCAS of Besançon
name: CCAS of Montbéliard
name: Burgundy Regional Council
name: Franche-Comté Regional Council
name: The Municipality of Besançon
name: The Municipality of Dijon
name: General Council of the Doubs
name: General Council of the Territoire de Belfort
name: Collectif Inter Associatif Sur la Sante Bourgogne
name: Union Régionale Interfédérale des Œuvres et Organismes Privés Sanitaires Bourgogne
name: Association Gérontopôle Pierre Pfitzenmeyer
name: Pôle de compétitivité Vitagora Goût-Nutrition-Santé
name: National Old Age Insurance Fund for Employees (CNAVTS)
name: Sheerbrooke Gérontopôle
name: France Alzheimer
name: Institut Régional de Vieillissement (IRV)
name: Novartis Pharmaceuticals
name: Roche Foundation
name: Ligue contre le cancer, France
name: National Cancer Institute, France
name: Quality of life and cancer clinical research platform
name: National Research Agency, France
First posted: 2015-12-10
Enrollment: 186
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: (Interventional Study) Comparison of caregivers' HRQoL according to the allocated intervention by randomization based on summaries score the MOS SF36
timeFrame: One year after randomization
measure: (Observational study) Changes in HRQoL of patients' caregivers using the MOS SF36 questionnaire
timeFrame: At 1, 3, 6, 9, 12, 15,18, 21, 24, 30, 36, 42, 48, 54 and 60 months post-randomization
measure: (Observational study) Changes in HRQoL of cancer patients' caregivers using the CarGoQoL questionnaire
timeFrame: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization
measure: (Observational study) Changes in the coping strategies of patients' caregivers using the Borteyrou, Rascle and Truchot Questionnaire
timeFrame: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
measure: (Observational study) Changes in feelings of anxiety and depression of patients' caregivers according to the HADs questionnaire
timeFrame: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization
measure: (Observational study) Changes in social support of patients' caregivers using the SSQ6 questionnaire
timeFrame: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
measure: (Observational study) Changes in burden of patients' caregivers using the Zarit burden inventory
timeFrame: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
Secondary outcomes:
measure: (Interventional Study) Comparison of caregivers' HRQoL according to the intervention allocated by randomization based on summaries score the MOS SF36
timeFrame: Two years after randomization
measure: (Interventional Study) Changes in HRQoL of patients' caregivers according to the allocated intervention using the MOS SF36 questionnaire
timeFrame: At 1, 3, 6, 9, 12, 15,18, 21, 24, 30, 36, 42, 48, 54 and 60 months post-randomization
measure: (Interventional Study) Changes in HRQoL of cancer patients' caregivers according to the allocated intervention using the CarGoQol questionnaire
timeFrame: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization
measure: (Interventionnal Study) Changes in the coping strategies of patients' caregivers according to the allocated intervention using the Borteyrou, Rascle and Truchot Questionnaire
timeFrame: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
measure: (Interventional Study) Changes in feelings of anxiety and depression of patients' caregivers according to the allocated intervention using the HADs Questionnaire
timeFrame: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization
measure: (Interventional Study) Changes in social supports of patients' caregivers according to the allocated intervention using the SSQ6 questionnaire
timeFrame: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
measure: (Interventional Study) Changes in burden of patients' caregivers according to the allocated intervention using the Zarit burden inventory
timeFrame: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
measure: (Interventional study) Efficiency of the intervention of a social worker for caregivers using a cost-utility analysis
timeFrame: At 1, 3, 6,9,12,15,18 and 24 months post-randomization
measure: (Observational study) Changes in the caregivers/patients' relationship using a qualitative approach (semi-structure interview)
timeFrame: At 1,6,12,18,24,30,36,42,48,54 and 60 months post randomization
measure: (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)
timeFrame: At 1,6,12,18,24,30,36,42,48,54 and 60 months post randomization
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHRU de Besançon
Study officials:
affiliation: Pôle Pharmaceutique CHU de Besançon
name: Virginie NERICH, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pozet A, Lejeune C, Bonnet M, Dabakuyo S, Dion M, Fagnoni P, Gaimard M, Imbert G, Nerich V, Foubert A, Chotard M, Bonin M, Anota A, Bonnetain F. 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. Trials. 2016 Nov 3;17(1):531. doi: 10.1186/s13063-016-1622-8.