NCT03240341

Brief Summary

The aim is to implement the Patient Activation Measure in paramedical practices as a tool to measure activation of patients in cancer care

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable cancer

Geographic Reach
1 country

6 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

First Submitted

Initial submission to the registry

July 26, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 28, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

2.8 years

First QC Date

July 26, 2017

Last Update Submit

May 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Activation Measure Questionnaire

    12 month

Secondary Outcomes (5)

  • Patient Activation Measure Questionnaire

    6 and 12 months

  • Visual Analog Scale for confidence level measurement about treatment

    6 and 12 months

  • Anxiety and Depression HAD Questionnaire

    6 and 12 months

  • REALM Health Literacy Test

    6 and 12 months

  • Quality of Life Questionnaire EQ-5D

    6 and 12 months

Study Arms (1)

Patient Activation Measure (PAM)

EXPERIMENTAL

completion of the PAM questionnaire

Behavioral: Patient Activation Measure Questionnaire

Interventions

Measure the level of patient engagement in cancer care pathway

Patient Activation Measure (PAM)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years
  • Cancer patient with an estimated life expectancy of at least one year
  • Patient requiring immunotherapy or intravenous chemotherapy for any cancer according to the decision of the Multidisciplinary Consultation Meeting
  • Patient affiliated or entitled to a social security scheme

You may not qualify if:

  • Refusal to participate, protected adult patient under guardianship.
  • Patient disability to understand the course of the study
  • Patient with documented history of cognitive or psychiatric disorders.
  • Patient not understanding French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre Hospitalier Emile Roux

Le Puy-en-Velay, 43000, France

Location

Clinique de l'infirmerie protestante de Lyon

Lyon, 69000, France

Location

Centre Hospitalier de Roanne

Roanne, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, 42270, France

Location

Hôpital Privé de la Loire

Saint-Etienne, 42270, France

Location

Related Publications (1)

  • Verot E, Bouleftour W, Macron C, Rivoirard R, Chauvin F. Effect of PARACT (PARAmedical Interventions on Patient ACTivation) on the Cancer Care Pathway: Protocol for Implementation of the Patient Activation Measure-13 Item (PAM-13) Version. JMIR Res Protoc. 2020 Dec 8;9(12):e17485. doi: 10.2196/17485.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Pierre Fournel, MD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 26, 2017

First Posted

August 7, 2017

Study Start

January 28, 2019

Primary Completion

October 28, 2021

Study Completion

October 20, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations