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

Breast Cancer Clinical Trial

— ICE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02626377
• Other study ID #: P/2014/231
• Status: Terminated
• Phase: N/A
• Start date: October 2015
• Est. completion date: May 2019

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 186
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Alzheimer Disease
• Breast Cancer
• Cardiac Disease
• Colorectal Cancer
• Heart Diseases
• Hemorrhagic Stroke
• Ischemic Stroke
• Macular Degeneration
• Parkinson Disease
• Prostate Cancer
• Stroke

Intervention

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)

Locations

Country	Name	City	State
France	CHRU de Besançon	Besançon

Sponsors (29)

Lead Sponsor

Collaborator

Centre Hospitalier Universitaire de Besancon

Association Gérontopôle Pierre Pfitzenmeyer, Burgundy Regional Council, CARSAT Bourgogne et Franche-Comté, CCAS of Besançon, CCAS of Dijon, CCAS of Montbéliard, Collectif Inter Associatif Sur la Sante Bourgogne, France Alzheimer, Franche-Comté Regional Council, General Council of the Doubs, General Council of the Territoire de Belfort, Institut Régional de Vieillissement (IRV), Ligue contre le cancer, France, Methodological and quality of life unit in oncology (CHRU de Besançon), National Cancer Institute, France, National Old Age Insurance Fund for Employees (CNAVTS), National Research Agency, France, Novartis Pharmaceuticals, Pôle de compétitivité Vitagora Goût-Nutrition-Santé, Pôle de Gérontologie Interrégional Bourgogne et Franche-Comté, Quality of life and cancer clinical research platform, Roche Foundation, Sheerbrooke Gérontopôle, The Municipality of Besançon, The Municipality of Dijon, Union Régionale Interfédérale des Œuvres et Organismes Privés Sanitaires Bourgogne, University of Burgundy, University of Franche-Comté

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(Interventional Study) Comparison of caregivers' HRQoL according to the allocated intervention by randomization based on summaries score the MOS SF36	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.	One year after randomization
Primary	(Observational study) Changes in HRQoL of patients' caregivers using the MOS SF36 questionnaire	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	At 1, 3, 6, 9, 12, 15,18, 21, 24, 30, 36, 42, 48, 54 and 60 months post-randomization
Primary	(Observational study) Changes in HRQoL of cancer patients' caregivers using the CarGoQoL questionnaire	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	At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization
Primary	(Observational study) Changes in the coping strategies of patients' caregivers using the Borteyrou, Rascle and Truchot Questionnaire	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.	At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
Primary	(Observational study) Changes in feelings of anxiety and depression of patients' caregivers according to the HADs questionnaire	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.	At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization
Primary	(Observational study) Changes in social support of patients' caregivers using the SSQ6 questionnaire	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.	At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
Primary	(Observational study) Changes in burden of patients' caregivers using the Zarit burden inventory	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	At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
Secondary	(Interventional Study) Comparison of caregivers' HRQoL according to the intervention allocated by randomization based on summaries score the MOS SF36	To compare the Health Related Quality of Life based on summaries score the MOS SF36 two years after randomization according to the allocated intervention.	Two years after randomization
Secondary	(Interventional Study) Changes in HRQoL of patients' caregivers according to the allocated intervention using the MOS SF36 questionnaire	To compare longitudinally all dimensions of HRQoL using the MOS SF36 questionnaire according to the allocated intervention.	At 1, 3, 6, 9, 12, 15,18, 21, 24, 30, 36, 42, 48, 54 and 60 months post-randomization
Secondary	(Interventional Study) Changes in HRQoL of cancer patients' caregivers according to the allocated intervention using the CarGoQol questionnaire	To compare longitudinally the HRQoL of cancer patients' caregivers, according to the allocated intervention, using the CarGoQol questionnaire.	At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization
Secondary	(Interventionnal Study) Changes in the coping strategies of patients' caregivers according to the allocated intervention using the Borteyrou, Rascle and Truchot Questionnaire	To compare longitudinally the coping strategies of patients' caregivers, according to the allocated intervention, using the Borteyrou, Rascle and Truchot Questionnaire.	At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
Secondary	(Interventional Study) Changes in feelings of anxiety and depression of patients' caregivers according to the allocated intervention using the HADs Questionnaire	To compare longitudinally the feelings of anxiety and depression of patients' caregivers, according to the allocated intervention, using the HADs Questionnaire.	At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization
Secondary	(Interventional Study) Changes in social supports of patients' caregivers according to the allocated intervention using the SSQ6 questionnaire	To compare longitudinally the social support of patients' caregivers, according to the allocated intervention, using the SSQ6 questionnaire.	At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
Secondary	(Interventional Study) Changes in burden of patients' caregivers according to the allocated intervention using the Zarit burden inventory	To compare longitudinally the burden of patients' caregivers, according to the allocated intervention, using the Zarit burden inventory.	At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
Secondary	(Interventional study) Efficiency of the intervention of a social worker for caregivers using a cost-utility analysis	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	At 1, 3, 6,9,12,15,18 and 24 months post-randomization
Secondary	(Observational study) Changes in the caregivers/patients' relationship using a qualitative approach (semi-structure interview)	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)	At 1,6,12,18,24,30,36,42,48,54 and 60 months post randomization
Secondary	(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)	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)	At 1,6,12,18,24,30,36,42,48,54 and 60 months post randomization

External Links

•   ICE study results article