Oncologic DisordersNCT02285296
The Needs and Burden of Family Caregivers of Older Adults With Cancer
A study testing personalized support program in people with Oncologic Disorders and Tumor, run by University Hospital, Lille at 2 sites in France.
Trial summary
Elderly cancer patients need more help from their relatives and for longer than young adults. Our hypothesis of research is that the needs and resources to help the couple " elderly patient/caregiver ", are at least in part socially determined and that the implementation of a personalized support plan to help the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncologic Disorders, Tumor
- What is being tested?
- personalized support program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Dec 2014to 1 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identification of a patient / caregiver couple
- Be the primary caregiver for at least one month of a subject
- Age ≥70 years
- With cancer
- Who benefited a comprehensive geriatric assessement at University Lille Hospital or Centre Oscar Lambret
- Affiliated to a social security or receiving an equivalent system of social protection
Show all 9Show fewer
- caregiver able to understand the nature, purpose and methodology of the study
- caregiver able to cooperate in interviews and questionnaires
- Written informed consent of the caregiver and the cancer patient provided before any study specific procedures
Who cannot join
- Caregiver < 18 years old
- Legal inability or restricted legal ability
- Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions
- patient's life expectancy less than 6 months (clinical assessment)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Needs and Burden of Family Caregivers of Older Adults With Cancer and Their Social Determinants
Elderly cancer patients need more help from their relatives and for longer than young adults.
Our hypothesis of research is that the needs and resources to help the couple " elderly patient/caregiver ", are at least in part socially determined and that the implementation of a personalized support plan to help the caregiver (PSP) taking into account needs, resources and expectations of the primary caregiver in addition to those of elderly patients with cancer may partly correct inequalities. The PSP should allow a better management of cancer, a lesser burden for the caregiver and a better quality of life for both the caregiver and the patient.
Read the detailed description
Scientific context Elderly cancer patients need more help from their relatives and for longer than young adults. The person who takes primary responsibility for someone who cannot care fully for themselves is called the primary caregiver.
A recent personal study concerning elderly cancer patients caregivers show that most caregivers reported high or moderate levels of psychological distress, with an impact on their own health status.
In addition, family caregivers often report deficits in information about the disease, in training and skills related to their patients' care, and a lack of assistance from healthcare professionals.
The ability of the primary caregiver to meet the medical, material and emotional needs of the patient depends on their own resources (psychological, physical, intellectual, physical, financial) and on the diversity of their social network, but it also depends on the quality of the personalized support program (including information and training) that has been established for them.
Research hypotheses
Our hypothesis of research is that the needs and resources to help the couple " elderly patient/caregiver ", are at least in part socially determined and that the implementation of a personalized support plan to help the caregiver (PSP) taking into account needs, resources and expectations of the primary caregiver in addition to those of elderly patients with cancer may partly correct inequalities. The PSP should allow a better management of cancer, a lesser burden for the caregiver and a better quality of life for both the caregiver and the patient.
Intervention description
Prospective, interventional, randomized trial, with 118 patients in each group:
- an experimental interventional arm including an interview of the primary caregivers to identify their needs and expectations, the implementation of a "personalized support program", including telephone follow-up
- A control arm corresponding to the standard care. Caregiver aid is usually proposed when accompanying a sick relative in consultation or hospitalization.
All the "couples patient / caregiver' will benefit initially from:
- a comprehensive geriatric assessment (elderly patients with cancer)
- an assessment of caregiver burden by the Zarit burden interview (ZBI)
- an assessment of subjective well-being
- an individual assessment of the precariousness and health inequalities based on the score EPICES (Evaluation of precariousness and health inequalities in the health Centers)
Randomization will be stratified according to:
- living in the same household or not
- score of initial Zarit Burden Interview
Intervention Stage 1: A semi-structured interview centered on the caregiver's needs (COAT tool) Stage 2: guided questionnaires to assess the psychosocial situation of caregivers Stage 3: implementation of a multi-component PSP (information, counseling, listening time, training to help overcome their difficulties as a caregiver, planning for future care) Stage 4: at least one monthly phone interview Stage 5: 6 months follow up on the psychosocial characteristics of caregivers
Expected results in public health Our study will help to better define the way to take better account of the needs of the helper / helped couple, and reinforce the role of the coordinating nurse in the care pathways.
If our hypotheses can confirmed that there is a link between the caregivers needs and the social determinants of health and that the intervention has a positive impact on the caregivers burden and stress, it will suggest that this intervention not only acts favorably on social inequalities in health, but it can help reduce health care costs, as the caregiver exhaustion increases the risk of health expenditure (drug consumption, hospitalization of the patient and of the caregiver).
- Conditions
- Oncologic Disorders, Tumor
- Being tested
- personalized support program
- Keywords
- geriatric assessment, Caregivers, Needs Assessment, oncology nursing, frail elderly, Medical, psychologic and sociologic approach
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized support programOther
interview of the primary caregivers to identify their needs and expectations, the implementation of a "personalized support program", including telephone follow-up
| Study group | Role | What they receive |
|---|---|---|
| control arm | No intervention | usual care |
| personalized support program | Experimental | interview of the primary caregivers to identify their needs and expectations, the implementation of a "personalized support program", including telephone follow-up Receives: Other: personalized support program |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in caregiver burden (22 items Zarit Burden Interview)
Measured: 6 months
Secondary outcomes (6)
Link between caregiver burden (ZBI) and the indicator of precariousness (EPICES score)
Measured: baseline evaluation
psychosocial characteristics of caregivers of patients with cancer
Caregiver Reaction Assessment (CRA) Carers' Assessment of Managing Index (CAMI) Inventory of social support (ISSB) Hospital Anxiety and Depression Scale (HADS) Cognitive Inventory of Subjective Distress (CISD) Subjective well-being scale (BES)
Measured: baseline and 6 months
Link between caregiver burden and geriatric syndromes
Measured: baseline and 6 months
Link between caregiver burden and stage of cancer / time from cancer diagnosis
Measured: baseline
Match between caregiver personalized support plan (PSP) objectives and effective implemented PSP
Measured: 6 months
Time spent for the development and implementation of the caregiver personalized support plan
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study start11 Dec 2014
- Primary completion12 Jun 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oncologic DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Oscar Lambret, University of Lille Nord de France, National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- GAXATTE Cédric, MD, Study chair, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285296
- Sponsor's protocol ID
- 2013_40
- Other IDs
- 2014-A00018-39
- Status last verified
- Mar 2018
- First submitted
- 4 Nov 2014
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Horn M, D'Hondt F, Vaiva G, Thomas P, Pins D. Categorical perception of familiarity: Evidence for a hyper-familiarity in schizophrenia. J Psychiatr Res. 2015 Dec;71:63-9. doi: 10.1016/j.jpsychires.2015.09.015. Epub 2015 Sep 30.
PubMed 26452199
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Needs and Burden of Family Caregivers of Older Adults With Cancer and Their Social Determinants
- ClinicalTrials.gov ID
- NCT02285296
- Acronym / sponsor ID
- 2013_40
- Conditions
- Oncologic Disorders, Tumor
- Keywords
- geriatric assessment, Caregivers, Needs Assessment, oncology nursing, frail elderly, Medical, psychologic and sociologic approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Centre Oscar Lambret, University of Lille Nord de France, National Cancer Institute, France
- Study start
- 11 Dec 2014 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 6 Nov 2014 (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.
Elderly cancer patients need more help from their relatives and for longer than young adults.
Our hypothesis of research is that the needs and resources to help the couple " elderly patient/caregiver ", are at least in part socially determined and that the implementation of a personalized support plan to help the caregiver (PSP) taking into account needs, resources and expectations of the primary caregiver in addition to those of elderly patients with cancer may partly correct inequalities. The PSP should allow a better management of cancer, a lesser burden for the caregiver and a better quality of life for both the caregiver and the patient.
Detailed description
Scientific context Elderly cancer patients need more help from their relatives and for longer than young adults. The person who takes primary responsibility for someone who cannot care fully for themselves is called the primary caregiver.
A recent personal study concerning elderly cancer patients caregivers show that most caregivers reported high or moderate levels of psychological distress, with an impact on their own health status.
In addition, family caregivers often report deficits in information about the disease, in training and skills related to their patients' care, and a lack of assistance from healthcare professionals.
The ability of the primary caregiver to meet the medical, material and emotional needs of the patient depends on their own resources (psychological, physical, intellectual, physical, financial) and on the diversity of their social network, but it also depends on the quality of the personalized support program (including information and training) that has been established for them.
Research hypotheses
Our hypothesis of research is that the needs and resources to help the couple " elderly patient/caregiver ", are at least in part socially determined and that the implementation of a personalized support plan to help the caregiver (PSP) taking into account needs, resources and expectations of the primary caregiver in addition to those of elderly patients with cancer may partly correct inequalities. The PSP should allow a better management of cancer, a lesser burden for the caregiver and a better quality of life for both the caregiver and the patient.
Intervention description
Prospective, interventional, randomized trial, with 118 patients in each group:
- an experimental interventional arm including an interview of the primary caregivers to identify their needs and expectations, the implementation of a "personalized support program", including telephone follow-up
- A control arm corresponding to the standard care. Caregiver aid is usually proposed when accompanying a sick relative in consultation or hospitalization.
All the "couples patient / caregiver' will benefit initially from:
- a comprehensive geriatric assessment (elderly patients with cancer)
- an assessment of caregiver burden by the Zarit burden interview (ZBI)
- an assessment of subjective well-being
- an individual assessment of the precariousness and health inequalities based on the score EPICES (Evaluation of precariousness and health inequalities in the health Centers)
Randomization will be stratified according to:
- living in the same household or not
- score of initial Zarit Burden Interview
Intervention Stage 1: A semi-structured interview centered on the caregiver's needs (COAT tool) Stage 2: guided questionnaires to assess the psychosocial situation of caregivers Stage 3: implementation of a multi-component PSP (information, counseling, listening time, training to help overcome their difficulties as a caregiver, planning for future care) Stage 4: at least one monthly phone interview Stage 5: 6 months follow up on the psychosocial characteristics of caregivers
Expected results in public health Our study will help to better define the way to take better account of the needs of the helper / helped couple, and reinforce the role of the coordinating nurse in the care pathways.
If our hypotheses can confirmed that there is a link between the caregivers needs and the social determinants of health and that the intervention has a positive impact on the caregivers burden and stress, it will suggest that this intervention not only acts favorably on social inequalities in health, but it can help reduce health care costs, as the caregiver exhaustion increases the risk of health expenditure (drug consumption, hospitalization of the patient and of the caregiver).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control arm | No intervention | –usual care |
| personalized support program | Experimental | Other: personalized support programinterview of the primary caregivers to identify their needs and expectations, the implementation of a "personalized support program", including telephone follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Identification of a patient / caregiver couple
- Be the primary caregiver for at least one month of a subject
- caregiver able to understand the nature, purpose and methodology of the study
- caregiver able to cooperate in interviews and questionnaires
- Written informed consent of the caregiver and the cancer patient provided before any study specific procedures
Key exclusion criteria (4 listed)
- Caregiver < 18 years old
- Legal inability or restricted legal ability
- Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions
- patient's life expectancy less than 6 months (clinical assessment)
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 |
|---|---|---|
| personalized support programinterview of the primary caregivers to identify their needs and expectations, the implementation of a "personalized support program", including telephone follow-up | Other | personalized support program |
Primary outcome
change in caregiver burden (22 items Zarit Burden Interview)
Time frame: 6 months
6 secondary outcomes
Link between caregiver burden (ZBI) and the indicator of precariousness (EPICES score)
Time frame: baseline evaluation
psychosocial characteristics of caregivers of patients with cancer
Time frame: baseline and 6 months
Link between caregiver burden and geriatric syndromes
Time frame: baseline and 6 months
Link between caregiver burden and stage of cancer / time from cancer diagnosis
Time frame: baseline
Match between caregiver personalized support plan (PSP) objectives and effective implemented PSP
Time frame: 6 months
Time spent for the development and implementation of the caregiver personalized support plan
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Results publication: PubMed 26452199Horn M, D'Hondt F, Vaiva G, Thomas P, Pins D. Categorical perception of familiarity: Evidence for a hyper-familiarity in schizophrenia. J Psychiatr Res. 2015 Dec;71:63-9. doi: 10.1016/j.jpsychires.2015.09.015. Epub 2015 Sep 30.
- Individual participant dataSharing planned: Undecided
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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.
GAXATTE Cédric, MD study chair
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized support program in people with Oncologic Disorders and Tumor, run by University Hospital, Lille at 2 sites 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 9 inclusion and 4 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: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in caregiver burden (22 items Zarit Burden Interview) (time frame: 6 months). 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 NCT02285296, which also lists 1 linked publication.
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 21 Apr 2026.