NCT02212132

Brief Summary

This pilot study is, in this new and original approach in cancer pathology, measure and explain the correspondence between perceived cognitive impairment (cognitive complaint) by cancer patients and their cognitive scores goals with tasks metamemory while controlling the anxiety and depression and fatigue factors of patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

April 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

August 4, 2014

Last Update Submit

August 5, 2015

Conditions

MetamemoryMemory ComplaintsPerformance MnemonicCancer

Keywords

metamemorymemory complaintsperformance mnemoniccancer

Outcome Measures

Primary Outcomes (1)

  • Evaluation of metamemory through questionnaires

    Comparison with questionnaires completed by healthy subjects matched controls.

    At study entry

Secondary Outcomes (1)

  • Influence of anxiety and depression and fatigue factors on metamemory.

    At study entry

Study Arms (2)

Patient

Neuropsychological evaluation, psychopathological assessment and fatigue

Other: behavioral assessments

Control group

Neuropsychological evaluation, psychopathological assessment and fatigue

Other: behavioral assessments

Interventions

behavioral assessmentsOTHER

Neuropsychological evaluation, psychopathological assessment and fatigue

Control groupPatient

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient being treated for a solid tumor or hematological

You may qualify if:

  • Patient being treated for a solid or hematologic malignancy;
  • Patients under 65 years of age;
  • Patients Grade 3 'end primary school "minimum (scale Barbizet);
  • Primary cancer of the central nervous system or brain metastases Absence;
  • No major cognitive disorders;
  • Lack of previous neurological;
  • Lack of personality disorders and evolutionary psychiatric pathology.

You may not qualify if:

  • Patients with paraneoplastic syndrome;
  • Scalable psychiatric pathology;
  • Refusal to participate;
  • Patients unable to meet the cognitive tests;
  • Use of drugs;
  • Heavy drinking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre François Baclesse

Caen, 14076, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Florence JOLY, PhD

    Centre François Baclesse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 8, 2014

Study Start

April 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations

FR(1)