Clinical trial NCT02583035: Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy
Official title: Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Hematologic Malignancy
Keywords: cancer
geriatric
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 131
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Memory on the Mini Mental Scale
timeFrame: 3 months after inclusion
measure: Falls on the number of falls
timeFrame: 3 months after inclusion
measure: Pain on the EVS (verbal scale) scale
timeFrame: 3 months after inclusion
measure: Autonomy on the ADL (activities of daily living) score
timeFrame: 3 months after inclusion
measure: Pain on the EN (numericale scale) scale
timeFrame: 3 months after inclusion
measure: Autonomy on the IADL (The Lawton Instrumental Activities of Daily Living Scale ) score
timeFrame: 3 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bayeux
country: France
facility: Centre Hospitalier
city: Caen
country: France
facility: CHU
city: Caen
country: France
facility: Centre François Baclesse
city: Dieppe
country: France
facility: Centre Hospitalier
city: Le Havre
country: France
facility: Centre Hospitalier du Havre
Study officials:
affiliation: University Hospital, Caen
name: Bérengère Beauplet, MD
role: PRINCIPAL_INVESTIGATOR
References: