Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy (TelOG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02583035
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse

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.


Condition or disease Intervention/treatment Phase
Cancer Hematologic Malignancy Other: Nurse telephone contact Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy
Study Start Date : February 2015
Actual Primary Completion Date : February 16, 2018
Actual Study Completion Date : May 14, 2018

Arm Intervention/treatment
Nurse telephone contact
3 days of consultation, telephone follow-up of the patient by the nurse coordinator of the Geriatric Oncology Unit to validate
Other: Nurse telephone contact
Nurse will contact patient 3 days before consultation




Primary Outcome Measures :
  1. Memory on the Mini Mental Scale [ Time Frame: 3 months after inclusion ]
  2. Falls on the number of falls [ Time Frame: 3 months after inclusion ]
  3. Pain on the EVS (verbal scale) scale [ Time Frame: 3 months after inclusion ]
  4. Autonomy on the ADL (activities of daily living) score [ Time Frame: 3 months after inclusion ]
  5. Pain on the EN (numericale scale) scale [ Time Frame: 3 months after inclusion ]
  6. Autonomy on the IADL (The Lawton Instrumental Activities of Daily Living Scale ) score [ Time Frame: 3 months after inclusion ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02583035


Locations
Layout table for location information
France
Centre Hospitalier
Bayeux, France
CHU
Caen, France, 14033
Centre François Baclesse
Caen, France, 14400
Centre Hospitalier
Dieppe, France
Centre Hospitalier du Havre
Le Havre, France
Sponsors and Collaborators
Centre Francois Baclesse
Investigators
Layout table for investigator information
Principal Investigator: Bérengère Beauplet, MD University Hospital, Caen

Layout table for additonal information
Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT02583035     History of Changes
Other Study ID Numbers: TelOG
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

Keywords provided by Centre Francois Baclesse:
cancer
geriatric

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases