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

January 15, 2019 updated by: Centre Francois Baclesse

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

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bayeux, France
        • Centre Hospitalier
      • Caen, France, 14033
        • CHU
      • Caen, France, 14400
        • Centre Francois Baclesse
      • Dieppe, France
        • Centre Hospitalier
      • Le Havre, France
        • Centre Hospitalier du Havre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bérengère Beauplet, MD, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

February 16, 2018

Study Completion (Actual)

May 14, 2018

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 21, 2015

Study Record Updates

Last Update Posted (Actual)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

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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