NCT02583035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2018

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

September 17, 2015

Last Update Submit

January 15, 2019

Conditions

Keywords

cancergeriatric

Outcome Measures

Primary Outcomes (6)

  • Memory on the Mini Mental Scale

    3 months after inclusion

  • Falls on the number of falls

    3 months after inclusion

  • Pain on the EVS (verbal scale) scale

    3 months after inclusion

  • Autonomy on the ADL (activities of daily living) score

    3 months after inclusion

  • Pain on the EN (numericale scale) scale

    3 months after inclusion

  • Autonomy on the IADL (The Lawton Instrumental Activities of Daily Living Scale ) score

    3 months after inclusion

Study Arms (1)

Nurse telephone contact

OTHER

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

Interventions

Nurse will contact patient 3 days before consultation

Nurse telephone contact

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre Hospitalier

Bayeux, France

Location

CHU

Caen, 14033, France

Location

Centre François Baclesse

Caen, 14400, France

Location

Centre Hospitalier

Dieppe, France

Location

Centre Hospitalier du Havre

Le Havre, France

Location

MeSH Terms

Conditions

NeoplasmsHematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Bérengère Beauplet, MD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2015

First Posted

October 21, 2015

Study Start

February 1, 2015

Primary Completion

February 16, 2018

Study Completion

May 14, 2018

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations