Influence of PARAmedical Interventions on Patient ACTivation in the Cancer Care Pathway (PARACT)

May 4, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne
The aim is to implement the Patient Activation Measure in paramedical practices as a tool to measure activation of patients in cancer care

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

600

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

  • France
      • Le Puy-en-Velay, France, 43000
        • Centre Hospitalier Emile Roux
      • Lyon, France, 69000
        • Clinique de l'Infirmerie Protestante de Lyon
      • Roanne, France
        • Centre hospitalier de Roanne
      • Saint-Étienne, France, 42055
        • CHU de Saint-Etienne
      • Saint-Étienne, France, 42270
        • Centre Hospitalier Universitaire de Saint-Etienne
      • Saint-Étienne, France, 42270
        • Hôpital Privé de la Loire

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient Activation Measure (PAM)
completion of the PAM questionnaire
Behavioral: Patient Activation Measure Questionnaire
Measure the level of patient engagement in cancer care pathway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient Activation Measure Questionnaire
Time Frame: 12 month
12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Activation Measure Questionnaire
Time Frame: 6 and 12 months
6 and 12 months
Visual Analog Scale for confidence level measurement about treatment
Time Frame: 6 and 12 months
6 and 12 months
Anxiety and Depression HAD Questionnaire
Time Frame: 6 and 12 months
6 and 12 months
REALM Health Literacy Test
Time Frame: 6 and 12 months
6 and 12 months
Quality of Life Questionnaire EQ-5D
Time Frame: 6 and 12 months
6 and 12 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Institut de Cancérologie de la Loire
Centre Hospitalier Emile Roux
Hôpital Privé de la Loire
Clinique de l'infirmerie protestante de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 28, 2019

Primary Completion (Actual)

October 28, 2021

Study Completion (Actual)

October 20, 2022

Study Registration Dates

First Submitted

July 26, 2017

First Submitted That Met QC Criteria

August 2, 2017

First Posted (Actual)

August 7, 2017

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2017-01
  • 2017-A00235-48 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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