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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02583035
Other study ID # TelOG
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date May 14, 2018

Study information

Verified date January 2019
Source Centre Francois Baclesse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There are no recommendations and few studies on the monitoring of fragile patients in the oncological treatment, both on the organizational arrangements on its interest in the prevention of functional deterioration of the patient and adaptation of the potential cancer treatment.

The oncogériatrique evaluation being time-consuming, requiring the movement of these more or less frail elderly patients, it seems difficult to envisage repeated and systematic standardized geriatric assessments during cancer treatment. Geriatric fragility can be detected by telephone. Craven et al. has already assessed the telephone follow-up by a nurse in patients treated for cancer, but with the aim to detect toxicities of cancer treatment, patients are not very old (mean age 64.8 years).

External evaluation by the nurse coordinator of UCOG (Coordination Unit in geriatric oncology) not knowing the patients included avoids bias of subjectivity in the interrogation.

However the telephone monitoring, with the aim to evaluate the evolution of geriatric frailty, has not been specifically studied in the elderly population treated for cancer, while taking oncology load.

The investigators wish to study the feasibility and validity of telephone follow-up which could eventually be used routinely to identify patients requiring further medical consultation oncogériatrique.


Recruitment information / eligibility

Status Completed
Enrollment 131
Est. completion date May 14, 2018
Est. primary completion date February 16, 2018
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria:

- Patients 70 years and older with cancer or hematologic malignancies;

- Faced benefit from cancer treatment (systemic treatment, curative radiotherapy) in one of the clinical sites;

- Addressed in onco-gériatric consultation in the usual routine care sector;

- Mastery of the French language;

- Patient affiliated to the social security system;

- Patient has given its written consent.

Exclusion Criteria:

- Life expectancy <3 months

- Inability to communicate by telephone (deafness, speech disorder, ..)

- Inability collection of written consent

- Group 4 SiO (International Society of Geriatric Oncology), Performance status (PS) 4

- initial MMSE (Mini-Mental State Examination) <18/30

- oncological treatment envisaged: analgesic radiotherapy or exclusive decompressive, brain radiation therapy in toto

- Patient under guardianship

Study Design


Intervention

Other:
Nurse telephone contact
Nurse will contact patient 3 days before consultation

Locations

Country Name City State
France Centre Hospitalier Bayeux
France Centre François Baclesse Caen
France CHU Caen
France Centre Hospitalier Dieppe
France Centre Hospitalier du Havre Le Havre

Sponsors (1)

Lead Sponsor Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Memory on the Mini Mental Scale 3 months after inclusion
Primary Falls on the number of falls 3 months after inclusion
Primary Pain on the EVS (verbal scale) scale 3 months after inclusion
Primary Autonomy on the ADL (activities of daily living) score 3 months after inclusion
Primary Pain on the EN (numericale scale) scale 3 months after inclusion
Primary Autonomy on the IADL (The Lawton Instrumental Activities of Daily Living Scale ) score 3 months after inclusion
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