Influence of PARAmedical Interventions on Patient ACTivation in the Cancer Care Pathway
PARACT
2 other identifiers
interventional
600
1 country
6
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Jan 2019
Typical duration for not_applicable cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2017
CompletedFirst Posted
Study publicly available on registry
August 7, 2017
CompletedStudy Start
First participant enrolled
January 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2022
CompletedMay 6, 2023
May 1, 2023
2.8 years
July 26, 2017
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)
EXPERIMENTALcompletion of the PAM questionnaire
Interventions
Measure the level of patient engagement in cancer care pathway
Eligibility Criteria
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
- Centre Hospitalier Universitaire de Saint Etiennelead
- Hôpital Privé de la Loirecollaborator
- Centre Hospitalier Emile Rouxcollaborator
- Clinique de l'infirmerie protestante de Lyoncollaborator
- Institut de Cancérologie de la Loirecollaborator
Study Sites (6)
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000, France
Clinique de l'infirmerie protestante de Lyon
Lyon, 69000, France
Centre Hospitalier de Roanne
Roanne, France
CHU de Saint-Etienne
Saint-Etienne, 42055, France
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, 42270, France
Hôpital Privé de la Loire
Saint-Etienne, 42270, France
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.
PMID: 33289495DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Fournel, MD
CHU de Saint-Etienne
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