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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03743961
Other study ID # 2018-0801
Secondary ID 2018-A02315-50
Status Terminated
Phase
First received
Last updated
Start date November 21, 2018
Est. completion date July 2, 2020

Study information

Verified date July 2020
Source Institut de Cancérologie de la Loire
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to describe the impact of : Geriatric intervention contribution on quality of life of elderly patients receiving systemic treatments for metastatic neoplasia


Description:

Elderly cancer incidence increases exponentially with advancing age. However, elderly patients are largely underrepresented in cancer treatment trials. The geriatric population presents particular physical, mental, psychological or social specificities that may condition the prognosis especially for patients with metastatic neoplasia. Recently, the measurement of quality of life (QoL) in aging population is being recognized as an important part of clinical decision. It is therefore essential to set up prospective studies to evaluate the impact of oncogeriatric practices on the quality of life of elderly patients with metastatic neoplasia. The main objective of this prospective study is to describe the contribution of geriatric intervention on quality of life for for elderly (> 75 years) with metastatic solid cancer receiving systemic treatment during the first 6 months of their therapeutic management.


Recruitment information / eligibility

Status Terminated
Enrollment 28
Est. completion date July 2, 2020
Est. primary completion date July 2, 2020
Accepts healthy volunteers
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria:

- Patient with solid metastatic neoplasia

- 75 years old or more

- Men or women

- ECOG between 0 and 3

- Patient receiving systemic antineoplasic treatment (chemotherapy, hormonotherapy, immunotherapy, targeted therapy)

Exclusion Criteria:

- ECOG 4

- Localized cancer

- Patients already included in a study witch could modify quality of life

- Patient unable to give their consent

Study Design


Intervention

Other:
geriatric intervention
Geriatric intervention

Locations

Country Name City State
France Institut de Cancérologie Lucien Neuwirth Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor Collaborator
Institut de Cancérologie de la Loire

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of quality of life Level of quality of life will be measured with the QoL ELD 14 (Quality Qf Life ELDerly patients with 14 Questions) 6 months
Primary Level of quality of life Level of quality of life will be measured with the QoL Q30 (Quality Qf Life with 30 Questions) 6 months
Secondary number of hospitalizations number of hospitalizations will be reported 6 months
Secondary Duration of hospitalizations Duration of hospitalizations will be reported in hours 6 months
Secondary Number of toxicities ( grade 3 and 4) Number of toxicities (grade 3 and 4) will be reported according to the CTCAE v4.0 (Common Terminology Criteria for Adverse Events) 6 months
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