NCT02777697

Brief Summary

The aim of this study is to investigate the predictive dimension of cognitive-emotional status of cancer patients on the chronic pain development 6 months after different cancer treatment protocol (surgery, chemotherapy, radiotherapy, hormone therapy, targeted therapy ...).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

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

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2018

Completed
Last Updated

April 2, 2020

Status Verified

May 1, 2016

Enrollment Period

2.6 years

First QC Date

April 13, 2016

Last Update Submit

March 31, 2020

Conditions

Chronic PainCancer

Keywords

cancer treatment protocolschronic cancer paincognitive functionquality of lifeanxietydepression

Outcome Measures

Primary Outcomes (1)

  • Measure of average pain intensity by a numerical rating scale

    Measure of average pain intensity by a numerical rating scale assessed 7 days before the 6 months visit after inclusion of patients.

    7 days before the visit

Secondary Outcomes (19)

  • Pain assessment by numerical rating scale and DN4

    at baseline

  • Pain assessment by numerical rating scale and DN4

    at 6 months

  • Pain assessment by numerical rating scale and DN4

    at 12 months

  • Pain assessment by numerical rating scale and DN4

    at 24 months

  • Pain assessment by numerical rating scale and DN4

    2 days after each cancer treatment protocol

  • +14 more secondary outcomes

Study Arms (1)

cancer patients

Other: chronic pain

Interventions

chronic painOTHER
cancer patients

Eligibility Criteria

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

cancer patients

You may qualify if:

  • Age ≥ 18 years
  • Cancer patient with one or more programmed cancer treatment protocols (chemotherapy, surgery, hormone therapy, radiation therapy, targeted therapy, ...)
  • Acceptance to sign the non-opposition form

You may not qualify if:

  • History of cancer and cancer treatment protocols (chemotherapy, surgery, hormone therapy, radiation therapy, targeted therapy, ...)
  • History and/or presence of primary brain tumors (glioblastoma, meningioma, neurofibroma ...)
  • History of neurological disorders (Parkinson's disease, Alzheimer's disease, dementia, epilepsy, moderate to severe head injury, ...)
  • History of psychiatric disorders (schizophrenia, bipolar disorder, ...)
  • Medical and surgical history incompatible with the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Chronic PainNeoplasmsAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Gisèle PICKERING

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 13, 2016

First Posted

May 19, 2016

Study Start

March 1, 2016

Primary Completion

October 15, 2018

Study Completion

November 12, 2018

Last Updated

April 2, 2020

Record last verified: 2016-05

Locations

FR(1)