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

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: Cancer
• Intervention / Treatment: Behavioral: PaRole OncO France : Individual peer support

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

• Study Contact: Name: Anne TERMOZ; Phone Number: +33 04 27 85 63 00; Email: anne.termoz@chu-lyon.fr
• Study Contact Backup: Name: Juile HASEBAERT, PhD; Phone Number: +33 4.72.11.51.65; Email: julie.haesebaert01@chu-lyon1.fr

Study Locations

• France
  • Lyon, France, 69495
    • Hospices Civils de Lyon
    • Contact: Sébastien COURAUD, MD; Email: sebastien.couraud@chu-lyon.fr

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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: Baseline measurement (before the intervention); After the intervention; Follow-up measurement (1months after the first intervention); 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	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	Hospital Anxiety and Depression Scale (Min: 0; Max: 42). Higher scores indicate levels of anxiety and depression	Baseline
Evolution of stress levels	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	EORTC QLQ-C30 questionnaire(Min : 0 ; Max : 100).Higher scores indicate better health status and quality of life	Baseline
Evolution of quality of life	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	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	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	Picker Patient Experience questionnaire(Min : 0 ; Max : 100). Higher scores indicate a better patient experience and greater satisfaction.	6 months
Patient empowerment	CASE-cancer questionnaire(Min :0 ; Max : 100). Higher scores indicate greater self-efficacy in managing cancer.	Baseline
Patient empowerment	CASE-cancer questionnaire(Min :0 ; Max : 100). Higher scores indicate greater self-efficacy in managing cancer.	1 month
Patient empowerment	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	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	SF-12 questionnaire(Min :0 ; Max : 100)Higher scores indicate better health-related quality of life.	Baseline, 1month, 6 month

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

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: Cancer; Peer support; participatory research; Patient advisor
• 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