The Needs and Burden of Family Caregivers of Older Adults With Cancer

Tumor Clinical Trial

Official title:

The Needs and Burden of Family Caregivers of Older Adults With Cancer and Their Social Determinants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02285296
• Other study ID #: 2013_40
• Secondary ID: 2014-A00018-39
• Status: Terminated
• Phase: N/A
• First received: November 4, 2014
• Last updated: March 13, 2018
• Start date: December 11, 2014
• Est. completion date: December 1, 2017

Study information

• Verified date: March 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: December 1, 2017
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Oncologic Disorders
• Tumor

Intervention

Other:
• personalized support program
interview of the primary caregivers to identify their needs and expectations, the implementation of a "personalized support program", including telephone follow-up

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille
France	University hospital, Lille	Lille

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Lille	Centre Oscar Lambret, National Cancer Institute, France, University of Lille Nord de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship between needs and EPICES score		baseline
Primary	change in caregiver burden (22 items Zarit Burden Interview)		6 months
Secondary	Link between caregiver burden (ZBI) and the indicator of precariousness (EPICES score)		baseline evaluation
Secondary	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)	baseline and 6 months
Secondary	Link between caregiver burden and geriatric syndromes		baseline and 6 months
Secondary	Link between caregiver burden and stage of cancer / time from cancer diagnosis		baseline
Secondary	Match between caregiver personalized support plan (PSP) objectives and effective implemented PSP		6 months
Secondary	Time spent for the development and implementation of the caregiver personalized support plan		6 months