Breast CancerICENCT02626377
Multicenter Prospective Cohort of Informal Caregivers in Burgundy and Franche-Comté
A study testing Support provided by social worker and Information booklet receipt in people with Breast Cancer and Colorectal Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Prostate Cancer
- What is being tested?
- Support provided by social worker and Information booklet receipt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 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;
Show all 10Show fewer
- ≥ 18 years old;
- not be an employee of a healthcare organization;
- living in Burgundy-Franche-Comte;
- to be able to complete questionnaires,
Who cannot join
- previously diagnosed with another targeted disease and/or living in retirement home could not be included
- Caregiver
- to be under guardianship, curatorship or under the protection of justice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Prospective Cohort of Informal Caregivers in Burgundy-Franche-Comté. ICE Cohort (Informal Caregivers of Elderly)
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.
- Conditions
- Breast Cancer, Colorectal Cancer, Prostate Cancer, Alzheimer Disease, Age-related Macular Degeneration, Parkinson Disease
- Being tested
- Support provided by social worker, Information booklet receipt
- Keywords
- Informal caregivers, Elderly, Quality of life, Cost effectiveness, Cohort study, Randomized study
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Alzheimer Disease, Macular Degeneration, Parkinson Disease, Heart Diseases, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support provided by social workerBehavioural
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.
Information booklet receiptOther
Caregivers will only receive an information booklet (which informs about existing structures and actions)
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | 'Support provided by social worker' Receives: Behavioral: Support provided by social worker; Other: Information booklet receipt |
| Non-interventional arm | Other | 'Information booklet receipt' Receives: Other: Information booklet receipt |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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.
Measured: One year after randomization
(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
Measured: At 1, 3, 6, 9, 12, 15,18, 21, 24, 30, 36, 42, 48, 54 and 60 months post-randomization
(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
Measured: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization
(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.
Measured: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
(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.
Measured: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization
(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.
Measured: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
(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
Measured: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
Secondary outcomes (10)
(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.
Measured: Two years after randomization
(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.
Measured: At 1, 3, 6, 9, 12, 15,18, 21, 24, 30, 36, 42, 48, 54 and 60 months post-randomization
(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.
Measured: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization
(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.
Measured: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
(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.
Measured: At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization
(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.
Measured: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
(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.
Measured: At 1, 6, 12, 24, 36, 48 and 60 months post-randomization
(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
Measured: At 1, 3, 6,9,12,15,18 and 24 months post-randomization
(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)
Measured: At 1,6,12,18,24,30,36,42,48,54 and 60 months post randomization
(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)
Measured: At 1,6,12,18,24,30,36,42,48,54 and 60 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2019
- Study completionMay 2019
Why it stopped: inclusions problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Virginie NERICH, Dr, Principal investigator, Pôle Pharmaceutique CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626377
- Sponsor's protocol ID
- P/2014/231
- Acronym
- ICE
- Status last verified
- Jul 2022
- First submitted
- 1 Dec 2015
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Pozet A, Falcoz A, Roller C, Jai T, Meurisse A, Nerich V. Health-state utility values and their time to deterioration in informal caregivers of older patients with chronic diseases. Front Public Health. 2025 Apr 30;13:1531608. doi: 10.3389/fpubh.2025.1531608. eCollection 2025.
PubMed 40371298Pozet A, Darnis S, Bonnet M, Meurisse A, Dabakuyo-Yonli TS, Lejeune C, Fagnoni P, Gaimard M, Manckoundia P, Quibel C, Marchand M, Anota A, Nerich V. Quality of Life and Needs in Caregivers: Results From the Prospective Multicentric Open-Label Randomized Study of Informal Caregivers of Elderly Patients. Int J Public Health. 2023 Aug 30;68:1605459. doi: 10.3389/ijph.2023.1605459. eCollection 2023.
PubMed 37711159Pozet 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.
PubMed 27881145
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Cohort of Informal Caregivers in Burgundy-Franche-Comté. ICE Cohort (Informal Caregivers of Elderly)
- ClinicalTrials.gov ID
- NCT02626377
- Acronym / sponsor ID
- ICE / P/2014/231
- Conditions
- Breast Cancer, Colorectal Cancer, Prostate Cancer, Alzheimer Disease, Age-related Macular Degeneration, Parkinson Disease
- Keywords
- Informal caregivers, Elderly, Quality of life, Cost effectiveness, Cohort study, Randomized study
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusions problems
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- 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
- Study start
- Oct 2015
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Behavioral: Support provided by social worker, Other: Information booklet receipt'Support provided by social worker' |
| Non-interventional arm | Other | Other: Information booklet receipt'Information booklet receipt' |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
- to be a member of the patient's social environment (family, friend and neighbor);
Key exclusion criteria (3 listed)
- previously diagnosed with another targeted disease and/or living in retirement home could not be included
- Caregiver
- to be under guardianship, curatorship or under the protection of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Support provided by social workerCaregivers 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. | Behavioural | Interventional arm |
| Information booklet receiptCaregivers will only receive an information booklet (which informs about existing structures and actions) | Other | Interventional arm, Non-interventional arm |
Primary outcome
(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.
(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
(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
(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.
(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.
(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.
(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
10 secondary outcomes
(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
(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
(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
(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
(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
(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
(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
(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
(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
(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
Results and safety
The study was stopped early (reason given: inclusions problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 40371298Pozet A, Falcoz A, Roller C, Jai T, Meurisse A, Nerich V. Health-state utility values and their time to deterioration in informal caregivers of older patients with chronic diseases. Front Public Health. 2025 Apr 30;13:1531608. doi: 10.3389/fpubh.2025.1531608. eCollection 2025.
- Derived from this study: PubMed 37711159Pozet A, Darnis S, Bonnet M, Meurisse A, Dabakuyo-Yonli TS, Lejeune C, Fagnoni P, Gaimard M, Manckoundia P, Quibel C, Marchand M, Anota A, Nerich V. Quality of Life and Needs in Caregivers: Results From the Prospective Multicentric Open-Label Randomized Study of Informal Caregivers of Elderly Patients. Int J Public Health. 2023 Aug 30;68:1605459. doi: 10.3389/ijph.2023.1605459. eCollection 2023.
- Derived from this study: PubMed 27881145Pozet 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.
- ICE study results articleLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginie NERICH, Dr principal investigator
Pôle Pharmaceutique CHU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support provided by social worker and Information booklet receipt in people with Breast Cancer and Colorectal Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inclusions problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02626377, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.