Cancer Clinical Trial
— TelOGOfficial title:
Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy
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 |
Verified date | January 2019 |
Source | Centre Francois Baclesse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Centre Francois Baclesse |
France,
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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