Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy (TelOG)
Primary Purpose
Cancer, Hematologic Malignancy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nurse telephone contact
Sponsored by
About this trial
This is an interventional other trial for Cancer focused on measuring cancer, geriatric
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
Sites / Locations
- Centre Hospitalier
- CHU
- Centre François Baclesse
- Centre Hospitalier
- Centre Hospitalier du Havre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Nurse telephone contact
Arm Description
3 days of consultation, telephone follow-up of the patient by the nurse coordinator of the Geriatric Oncology Unit to validate
Outcomes
Primary Outcome Measures
Memory on the Mini Mental Scale
Falls on the number of falls
Pain on the EVS (verbal scale) scale
Autonomy on the ADL (activities of daily living) score
Pain on the EN (numericale scale) scale
Autonomy on the IADL (The Lawton Instrumental Activities of Daily Living Scale ) score
Secondary Outcome Measures
Full Information
NCT ID
NCT02583035
First Posted
September 17, 2015
Last Updated
January 15, 2019
Sponsor
Centre Francois Baclesse
1. Study Identification
Unique Protocol Identification Number
NCT02583035
Brief Title
Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy
Acronym
TelOG
Official Title
Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 16, 2018 (Actual)
Study Completion Date
May 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Hematologic Malignancy
Keywords
cancer, geriatric
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nurse telephone contact
Arm Type
Other
Arm Description
3 days of consultation, telephone follow-up of the patient by the nurse coordinator of the Geriatric Oncology Unit to validate
Intervention Type
Other
Intervention Name(s)
Nurse telephone contact
Intervention Description
Nurse will contact patient 3 days before consultation
Primary Outcome Measure Information:
Title
Memory on the Mini Mental Scale
Time Frame
3 months after inclusion
Title
Falls on the number of falls
Time Frame
3 months after inclusion
Title
Pain on the EVS (verbal scale) scale
Time Frame
3 months after inclusion
Title
Autonomy on the ADL (activities of daily living) score
Time Frame
3 months after inclusion
Title
Pain on the EN (numericale scale) scale
Time Frame
3 months after inclusion
Title
Autonomy on the IADL (The Lawton Instrumental Activities of Daily Living Scale ) score
Time Frame
3 months after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bérengère Beauplet, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier
City
Bayeux
Country
France
Facility Name
CHU
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14400
Country
France
Facility Name
Centre Hospitalier
City
Dieppe
Country
France
Facility Name
Centre Hospitalier du Havre
City
Le Havre
Country
France
12. IPD Sharing Statement
Learn more about this trial
Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy
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