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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France2 sites
  • Centre Oscar Lambret

    Lille

  • University hospital, Lille

    Lille

Other trials in France

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:

  1. a comprehensive geriatric assessment (elderly patients with cancer)
  2. an assessment of caregiver burden by the Zarit burden interview (ZBI)
  3. an assessment of subjective well-being
  4. 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).

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 groups in NCT02285296
Study groupRoleWhat they receive
control armNo interventionusual care
personalized support programExperimentalinterview 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.

  1. change in caregiver burden (22 items Zarit Burden Interview)

    Measured: 6 months

Secondary outcomes (6)
  1. Link between caregiver burden (ZBI) and the indicator of precariousness (EPICES score)

    Measured: baseline evaluation

  2. 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

  3. Link between caregiver burden and geriatric syndromes

    Measured: baseline and 6 months

  4. Link between caregiver burden and stage of cancer / time from cancer diagnosis

    Measured: baseline

  5. Match between caregiver personalized support plan (PSP) objectives and effective implemented PSP

    Measured: 6 months

  6. 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.

  1. First posted6 Nov 2014 (estimated)
  2. Study start11 Dec 2014
  3. Primary completion12 Jun 2017
  4. Study completion1 Dec 2017

Resources

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)
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

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.

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