NCT06817655

Brief Summary

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. 1.Evaluating clinical and psychosocial parameters
  2. 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
720

participants targeted

Target at P75+ for not_applicable cancer

Timeline
13mo left

Started Mar 2025

Typical duration for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Study Progress53%
Mar 2025Jun 2027

First Submitted

Initial submission to the registry

January 29, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2027

Last Updated

February 10, 2025

Status Verified

January 1, 2025

Enrollment Period

2.3 years

First QC Date

January 29, 2025

Last Update Submit

February 5, 2025

Conditions

Keywords

Peer supportCancerparticipatory researchPatient advisor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Evolution of stress levels

    Baseline

  • Evolution of stress levels

    6 months

  • Evolution of quality of life

    Baseline

  • Evolution of quality of life

    1 month, 6 month

  • Evolution of patient-perceived care experience

    Baseline

  • +7 more secondary outcomes

Study Arms (1)

Supportive care (PaRole OncO France program)

EXPERIMENTAL

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

Interventions

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.

Supportive care (PaRole OncO France program)

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospices Civils de Lyon

Lyon, 69495, France

Location

Hospices Civils de Lyon

Lyon, 69495, France

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The intervention consists of patient accompaniment by patient advisors. At least one patient advisor is recruited in each service participating in the study. Patients will be paired with patient advisor and can benefit from accompaniment during their hospital stays or remotely (by phone). The patient advisor will, in turn, be supported by the healthcare professionals' team as well as through a community of practice.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 10, 2025

Study Start

March 15, 2025

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

June 15, 2027

Last Updated

February 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations