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AzTrials

CancerPROOFNCT06817655

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

A study testing PaRole OncO France : Individual peer support in people with Cancer, run by Hospices Civils de Lyon at 2 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Cancer
What is being tested?
PaRole OncO France : Individual peer support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
720 participants
Where
2 sitesFrance
Study dates
15 Mar 2025to 15 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Juile HASEBAERT, PhD contact

4.72.11.51.65 ext. +33

julie.haesebaert01@chu-lyon1.fr

Anne TERMOZ contact

04 27 85 63 00 ext. +33

anne.termoz@chu-lyon.fr

France2 sites

  • Hospices Civils de Lyon

    Lyon, 69495

    Stéphane DALLE, MD, stephane.dalle@chu-lyon.fr

  • Hospices Civils de Lyon

    Lyon, 69495

    Sébastien COURAUD, MD, sebastien.couraud@chu-lyon.fr

Other trials in France

About this study

Official title: 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.
Read the 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.
Conditions
Cancer
Being tested
PaRole OncO France : Individual peer support
Keywords
Peer support, Cancer, participatory research, Patient advisor
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaRole OncO France : Individual peer supportBehavioural

    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.

Study groups in NCT06817655
Study groupRoleWhat they receive
Supportive care (PaRole OncO France program)ExperimentalPatients 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.
Receives: Behavioral: PaRole OncO France : Individual peer support

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 months

Secondary outcomes (12)

  1. Evolution of stress levels

    Hospital Anxiety and Depression Scale (Min: 0; Max: 42). Higher scores indicate levels of anxiety and depression

    Measured: Baseline

  2. Evolution of stress levels

    Hospital Anxiety and Depression Scale ((Min : 0; Max : 42).Higher scores indicate greater levels of anxiety and depression.

    Measured: 6 months

  3. Evolution of quality of life

    EORTC QLQ-C30 questionnaire(Min : 0 ; Max : 100).Higher scores indicate better health status and quality of life

    Measured: Baseline

  4. Evolution of quality of life

    EORTC QLQ-C30 questionnaire(Min : 0 ; Max : 100).Higher scores indicate better health status and quality of life.

    Measured: 1 month, 6 month

  5. Evolution of patient-perceived care experience

    Picker Patient Experience questionnaire(Min : 0 ; Max : 100).Higher scores indicate a better patient experience and greater satisfaction.

    Measured: Baseline

  6. Evolution of patient-perceived care experience

    Picker Patient Experience questionnaire(Min : 0 ; Max : 100).Higher scores indicate a better patient experience and greater satisfaction.

    Measured: 1 month

  7. Evolution of patient-perceived care experience

    Picker Patient Experience questionnaire(Min : 0 ; Max : 100). Higher scores indicate a better patient experience and greater satisfaction.

    Measured: 6 months

  8. Patient empowerment

    CASE-cancer questionnaire(Min :0 ; Max : 100). Higher scores indicate greater self-efficacy in managing cancer.

    Measured: Baseline

  9. Patient empowerment

    CASE-cancer questionnaire(Min :0 ; Max : 100). Higher scores indicate greater self-efficacy in managing cancer.

    Measured: 1 month

  10. Patient empowerment

    CASE-cancer questionnaire(Min :0 ; Max : 100). Higher scores indicate greater self-efficacy in managing cancer.

    Measured: 6 month

  11. 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

    Measured: Baseline;1 month and 6 month after intervention

  12. Evolution of quality of life of patient advisors

    SF-12 questionnaire(Min :0 ; Max : 100)Higher scores indicate better health-related quality of life.

    Measured: Baseline, 1month, 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2025
  2. Study start15 Mar 2025 (estimated)
  3. Primary completion15 Jun 2027 (estimated)
  4. Study completion15 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
720 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06817655
Sponsor's protocol ID
69HCL23_1301
Acronym
PROOF
Status last verified
Jan 2025
First submitted
29 Jan 2025
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Busnel Y, Pomey MP, Termoz A, Christophe V, Tournigand C, Jouet E, Panse L, Cognon S, Ganter C, Villate A, Maisani P, Preau M, Haesebaert J; Proof investigators group. Implementation and evaluation of a peer-to-peer support program in oncology: study protocol for the PaRole Onco France model. Arch Public Health. 2026 Jan 30;84(1):24. doi: 10.1186/s13690-025-01827-6.

    PubMed 41612477

Questions about this trial

What is this clinical trial studying?

A study testing PaRole OncO France : Individual peer support in people with Cancer, run by Hospices Civils de Lyon at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Juile HASEBAERT, PhD (4.72.11.51.65 ext. +33, julie.haesebaert01@chu-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of implementation of the Peer Support Program in Oncology (time frame: 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06817655, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.

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