NCT04478903

Brief Summary

Cancer is a disease that requires long-term management, especially now that medical advances have transformed most cancers from an acute to a chronic condition. Most of the time, therefore, the help provided by family and friends is long-term. The negative impact of oncological care on the quality of life of family caregivers has already been studied. The UCOGB carried out a study in 2014 on the primary caregivers of cancer patients aged 70 and over at inclusion and at 3 and 6 months of oncogeriatric care. This study showed that several factors were significantly related to the caregiver's quality of life: the caregiver's age, perception of burden and patient autonomy (18). However, the evolution of quality of life and burden at 5 years has, to our knowledge, never been evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2020

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

July 16, 2020

Last Update Submit

March 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • To determine the quality of life of the primary caregiver of cancer patients 70 years of age and older, 5 years after initial management.

    Quality of life is measured using the SF-12 (short form) questionnaire. This is an abbreviated version of the Medical Outcomes Study Short-form General Health survey (SF-36).

    Through study completion, an average of 1 year

Study Arms (1)

primary caregiver of patients aged 70 and over

Other: Questionnaire

Interventions

Zarit Burden Inventory French version and SF12

primary caregiver of patients aged 70 and over

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrieval of information and contact details of primary caregivers included in the 2014 study along with the patient's vital status

You may qualify if:

  • Person who does not object to being included in the study
  • Primary caregiver of a cancer patient aged 70 years and over who is managed in one of the centres participating in the study, with a request for an oncogeriatric consultation between 01/06/2014 and 18/03/2015.
  • Age ≥ 18 years old
  • Good command of the French language

You may not qualify if:

  • Refusal or linguistic or psychological inability to answer the questionnaires.
  • Caregiver whose general condition does not allow him/her to answer a questionnaire
  • Death of the caregiver.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (1)

  • Barben J, Billa O, Collot J, Collot T, Manckoundia P, Bengrine-Lefevre L, Dabakuyo-Yonli TS, Quipourt V. Quality of life and perceived burden of the primary caregiver of patients aged 70 and over with cancer 5 years after initial treatment. Support Care Cancer. 2023 Feb 2;31(2):147. doi: 10.1007/s00520-023-07594-w.

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 21, 2020

Study Start

June 15, 2020

Primary Completion

November 16, 2020

Study Completion

November 16, 2020

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations