NCT02285296

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

December 11, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 21, 2026

Status Verified

March 1, 2018

Enrollment Period

2.5 years

First QC Date

November 4, 2014

Last Update Submit

April 16, 2026

Conditions

Oncologic DisordersTumor

Keywords

geriatric assessmentCaregiversNeeds Assessmentoncology nursingfrail elderlyMedical, psychologic and sociologic approach

Outcome Measures

Primary Outcomes (1)

  • change in caregiver burden (22 items Zarit Burden Interview)

    6 months

Secondary Outcomes (6)

  • Link between caregiver burden (ZBI) and the indicator of precariousness (EPICES score)

    baseline evaluation

  • psychosocial characteristics of caregivers of patients with cancer

    baseline and 6 months

  • Link between caregiver burden and geriatric syndromes

    baseline and 6 months

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

    baseline

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

    6 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Relationship between needs and EPICES score

    baseline

Study Arms (2)

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

Other: personalized support program

Interventions

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

personalized support program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Oscar Lambret

Lille, France

Location

University hospital, Lille

Lille, France

Location

Related Publications (1)

  • 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.

    PMID: 26452199RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

  • GAXATTE Cédric, MD

    University Hospital, Lille

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 6, 2014

Study Start

December 11, 2014

Primary Completion

June 12, 2017

Study Completion

December 1, 2017

Last Updated

April 21, 2026

Record last verified: 2018-03

Locations

FR(2)