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

Primary Purpose

Breast Cancer, Colorectal Cancer, Prostate Cancer

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Support provided by social worker

Information booklet receipt

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Informal caregivers, Elderly, Quality of life, Cost effectiveness, Cohort study, Randomized study

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHRU de Besançon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Interventional arm

Non-interventional arm

Arm Description

'Support provided by social worker'

'Information booklet receipt'

Outcomes

Primary Outcome Measures

(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.

(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

(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

(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.

(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.

(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.

(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

Secondary Outcome Measures

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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

(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)

(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)

Full Information

NCT ID

NCT02626377

First Posted

December 1, 2015

Last Updated

October 20, 2023

Sponsor

Centre Hospitalier Universitaire de Besancon

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, National Old Age Insurance Fund for Employees (CNAVTS), Sheerbrooke Gérontopôle, France Alzheimer, 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

1. Study Identification

Unique Protocol Identification Number

NCT02626377

Brief Title

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

Acronym

ICE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Terminated

Why Stopped

inclusions problems

Study Start Date

October 2015 (undefined)

Primary Completion Date

May 2019 (Actual)

Study Completion Date

May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

186 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Interventional arm

Arm Type

Experimental

Arm Description

'Support provided by social worker'

Arm Title

Non-interventional arm

Arm Type

Other

Arm Description

'Information booklet receipt'

Intervention Type

Behavioral

Intervention Name(s)

Support provided by social worker

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Information booklet receipt

Intervention Description

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

Primary Outcome Measure Information:

Title

(Interventional Study) Comparison of caregivers' HRQoL according to the allocated intervention by randomization based on summaries score the MOS SF36

Description

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.

Time Frame

One year after randomization

Title

(Observational study) Changes in HRQoL of patients' caregivers using the MOS SF36 questionnaire

Description

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

Time Frame

At 1, 3, 6, 9, 12, 15,18, 21, 24, 30, 36, 42, 48, 54 and 60 months post-randomization

Title

(Observational study) Changes in HRQoL of cancer patients' caregivers using the CarGoQoL questionnaire

Description

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

Time Frame

At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization

Title

(Observational study) Changes in the coping strategies of patients' caregivers using the Borteyrou, Rascle and Truchot Questionnaire

Description

Time Frame

At 1, 6, 12, 24, 36, 48 and 60 months post-randomization

Title

(Observational study) Changes in feelings of anxiety and depression of patients' caregivers according to the HADs questionnaire

Description

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.

Time Frame

At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization

Title

(Observational study) Changes in social support of patients' caregivers using the SSQ6 questionnaire

Description

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.

Time Frame

At 1, 6, 12, 24, 36, 48 and 60 months post-randomization

Title

(Observational study) Changes in burden of patients' caregivers using the Zarit burden inventory

Description

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

Time Frame

At 1, 6, 12, 24, 36, 48 and 60 months post-randomization

Secondary Outcome Measure Information:

Title

(Interventional Study) Comparison of caregivers' HRQoL according to the intervention allocated by randomization based on summaries score the MOS SF36

Description

To compare the Health Related Quality of Life based on summaries score the MOS SF36 two years after randomization according to the allocated intervention.

Time Frame

Two years after randomization

Title

(Interventional Study) Changes in HRQoL of patients' caregivers according to the allocated intervention using the MOS SF36 questionnaire

Description

To compare longitudinally all dimensions of HRQoL using the MOS SF36 questionnaire according to the allocated intervention.

Time Frame

At 1, 3, 6, 9, 12, 15,18, 21, 24, 30, 36, 42, 48, 54 and 60 months post-randomization

Title

(Interventional Study) Changes in HRQoL of cancer patients' caregivers according to the allocated intervention using the CarGoQol questionnaire

Description

To compare longitudinally the 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

Title

(Interventionnal Study) Changes in the coping strategies of patients' caregivers according to the allocated intervention using the Borteyrou, Rascle and Truchot Questionnaire

Description

To compare longitudinally 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

Title

(Interventional Study) Changes in feelings of anxiety and depression of patients' caregivers according to the allocated intervention using the HADs Questionnaire

Description

To compare longitudinally the 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

Title

(Interventional Study) Changes in social supports of patients' caregivers according to the allocated intervention using the SSQ6 questionnaire

Description

To compare longitudinally the social support 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

Title

(Interventional Study) Changes in burden of patients' caregivers according to the allocated intervention using the Zarit burden inventory

Description

To compare longitudinally the 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

Title

(Interventional study) Efficiency of the intervention of a social worker for caregivers using a cost-utility analysis

Description

Time Frame

At 1, 3, 6,9,12,15,18 and 24 months post-randomization

Title

(Observational study) Changes in the caregivers/patients' relationship using a qualitative approach (semi-structure interview)

Description

Time Frame

At 1,6,12,18,24,30,36,42,48,54 and 60 months post randomization

Title

Description

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)

Time Frame

At 1,6,12,18,24,30,36,42,48,54 and 60 months post randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Virginie NERICH, Dr

Organizational Affiliation

Pôle Pharmaceutique CHU de Besançon

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHRU de Besançon

City

Besançon

ZIP/Postal Code

25030

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

27881145

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.

Results Reference

derived

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/37711159/

Description

ICE study results article

Learn more about this trial

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

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