The Research of French PaRole OncO : A Peer Supported Program for Cancer Patients (PROOF)

February 5, 2025 updated by: Hospices Civils de Lyon

Implementation and Evaluation of Peer Support in Oncology in France : a Multisite Participatory Action Research - Adaptation and Transfer in France of the Quebec PAROLE ONCO Research Program

Peer support is a valuable mode of accompaniment between individuals who are facing or have faced similar challenging life experiences. In this context, a patient advisor (PA) shares their experiential knowledge, derived from living with a disease, to offer emotional, experiential, and informational support to other patients. This PA intervention represents an innovative form of support for oncology patients, potentially addressing their needs more comprehensively throughout the care pathway by integrating psychosocial dimensions into the support approach.

The present pilot study aims to investigate the implementation and effectiveness of the peer-to-peer support program "PaRole OncO France" in the oncology setting. The study will focus on:

  1. Evaluating clinical and psychosocial parameters
  2. Utilizing an in-depth multiple case study approach This research seeks to provide insights into how peer support can enhance the overall care experience for oncology patients, potentially leading to improved patient outcomes and a more holistic approach to cancer care.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Peer support is a valuable mode of accompaniment between individuals who are facing or have faced similar challenging life experiences. In this context, a patient advisor (PA) shares their experiential knowledge, derived from living with a disease, to offer emotional, experiential, and informational support to other patients. This PA intervention represents an innovative form of support for oncology patients, potentially addressing their needs more comprehensively throughout the care pathway by integrating psychosocial dimensions into the support approach.

The present pilot study aims to investigate the implementation and effectiveness of the peer-to-peer support program "PaRole OncO France" in the oncology setting. The study will focus on:

  1. Evaluating clinical and psychosocial parameters
  2. Utilizing an in-depth multiple case study approach This research seeks to provide insights into how peer support can enhance the overall care experience for oncology patients, potentially leading to improved patient outcomes and a more holistic approach to cancer care.

Study Type

Interventional

Enrollment (Estimated)

720

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 Contact

Study Contact Backup

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient participants :

    • Patients with newly diagnosed or recurrent cancer (urological, digestive, mammary, pulmonary, ORL, peritoneal carcinosis, melanoma, oncohaematology)
    • French-speaking patients

  • Patients adivsors :

    • Patient advisors will be past cancer patients not currently undergoing treatment for their cancer, and considered without evidence of disease
    • French-speaking patients

Exclusion Criteria:

  • Patients participants :

    • Not followed in one of the participating units
    • Persons deprived of their liberty by judicial or administrative decision
    • Persons not affiliated to a social security scheme or beneficiaries of a similar scheme

  • Patient advisors :

    • Recurrence of the disease
    • Currently undergoing treatment for active cancer

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: Supportive care (PaRole OncO France program)
Patients participate in the PaRole OncO France program for which they are matched with a patient advisor and followed throughout treatment in person and/or phone.
Behavioral: PaRole OncO France : Individual peer support

Following the development of the peer support program "PaRole OncO France", we are now proceeding with its implementation and evaluation through a pilot study. This study aims to derive both implementation-related and clinically relevant results.

Prior to their assignment, all peer helpers undergo a comprehensive training course to ensure they are well-equipped for their role.

Patients receive individual peer support during their treatment visits, providing real-time assistance and support within the clinical setting.

The study incorporates three key measurement time points:

  1. Baseline measurement (before the intervention)
  2. After the intervention
  3. Follow-up measurement (1months after the first intervention)
  4. Follow-up measurement (6 months after the first intervention)

At each time points, participants will complete a set of standardized questionnaires. These instruments are designed to capture relevant outcomes and experiences related to the peer support intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of implementation of the Peer Support Program in Oncology
Time Frame: 30 months
Acceptability of PH intervention by patients, professionals, and PAs Number of PHs integrated per unit Maintenance of PH activity during the study period in each unit Primary outcome measure is multidimensional by design, as the evaluation of a peer support program requires simultaneous analysis of complementary aspects (acceptability, feasibility, fidelity). These elements are inherently interconnected within our methodological framework.
30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of stress levels
Time Frame: Baseline
Hospital Anxiety and Depression Scale (Min: 0; Max: 42). Higher scores indicate levels of anxiety and depression
Baseline
Evolution of stress levels
Time Frame: 6 months
Hospital Anxiety and Depression Scale ((Min : 0; Max : 42).Higher scores indicate greater levels of anxiety and depression.
6 months
Evolution of quality of life
Time Frame: Baseline
EORTC QLQ-C30 questionnaire(Min : 0 ; Max : 100).Higher scores indicate better health status and quality of life
Baseline
Evolution of quality of life
Time Frame: 1 month, 6 month
EORTC QLQ-C30 questionnaire(Min : 0 ; Max : 100).Higher scores indicate better health status and quality of life.
1 month, 6 month
Evolution of patient-perceived care experience
Time Frame: Baseline
Picker Patient Experience questionnaire(Min : 0 ; Max : 100).Higher scores indicate a better patient experience and greater satisfaction.
Baseline
Evolution of patient-perceived care experience
Time Frame: 1 month
Picker Patient Experience questionnaire(Min : 0 ; Max : 100).Higher scores indicate a better patient experience and greater satisfaction.
1 month
Evolution of patient-perceived care experience
Time Frame: 6 months
Picker Patient Experience questionnaire(Min : 0 ; Max : 100). Higher scores indicate a better patient experience and greater satisfaction.
6 months
Patient empowerment
Time Frame: Baseline
CASE-cancer questionnaire(Min :0 ; Max : 100). Higher scores indicate greater self-efficacy in managing cancer.
Baseline
Patient empowerment
Time Frame: 1 month
CASE-cancer questionnaire(Min :0 ; Max : 100). Higher scores indicate greater self-efficacy in managing cancer.
1 month
Patient empowerment
Time Frame: 6 month
CASE-cancer questionnaire(Min :0 ; Max : 100). Higher scores indicate greater self-efficacy in managing cancer.
6 month
Evolution of relationship between accompanied patients and healthcare professionals
Time Frame: Baseline;1 month and 6 month after intervention
CADICEE questionnaire(Min :0 ; Max : 100). Higher scores indicate a better perception of patient-healthcare partnership
Baseline;1 month and 6 month after intervention
Evolution of quality of life of patient advisors
Time Frame: Baseline, 1month, 6 month
SF-12 questionnaire(Min :0 ; Max : 100)Higher scores indicate better health-related quality of life.
Baseline, 1month, 6 month

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

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 (Estimated)

March 15, 2025

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

June 15, 2027

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL23_1301

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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