- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02583035
Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy (TelOG)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bayeux, France
- Centre hospitalier
-
Caen, France, 14033
- CHU
-
Caen, France, 14400
- Centre François Baclesse
-
Dieppe, France
- Centre hospitalier
-
Le Havre, France
- Centre Hospitalier du Havre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Nurse telephone contact
3 days of consultation, telephone follow-up of the patient by the nurse coordinator of the Geriatric Oncology Unit to validate
|
Nurse will contact patient 3 days before consultation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Memory on the Mini Mental Scale
Time Frame: 3 months after inclusion
|
3 months after inclusion
|
|
Falls on the number of falls
Time Frame: 3 months after inclusion
|
3 months after inclusion
|
|
Pain on the EVS (verbal scale) scale
Time Frame: 3 months after inclusion
|
3 months after inclusion
|
|
Autonomy on the ADL (activities of daily living) score
Time Frame: 3 months after inclusion
|
3 months after inclusion
|
|
Pain on the EN (numericale scale) scale
Time Frame: 3 months after inclusion
|
3 months after inclusion
|
|
Autonomy on the IADL (The Lawton Instrumental Activities of Daily Living Scale ) score
Time Frame: 3 months after inclusion
|
3 months after inclusion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bérengère Beauplet, MD, University Hospital, Caen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TelOG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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