PROACT is a Prospective Master Protocol for a Cohort Study Focused on Evaluating the Implementation of Integrated Proactive Supportive Care Pathways at Gustave Roussy (PROACT)

Integrating PROACTive Care Pathways to Empower and Support Cancer Patients (PROACT)

PROACT is a prospective master protocol for a cohort study focused on evaluating the implementation of integrated proactive pathways of supportive care.

This is an observational cohort study in the context of a quality-of-care initiative.

It will be evaluated by its impact on patient's distress measured by the NCCN's Distress thermometer at 12 weeks after entering the pathway.

Study Overview

• Status: Recruiting
• Conditions: Any Cancer
• Intervention / Treatment: Other: Supportive Care Pathway

Detailed Description

The primary study endpoint of PROACT is patient distress and supportive care needs (NCCN Distress Thermometer and NCCN Problem list) over a 12-week period after the supportive care needs assessment and referrals in the context of a PROACT pathway.

Secondary study endpoints include:

1. To evaluate the Reach of each pathway through the number of patients who participated in supportive care needs' assessment and in each supportive care intervention (administrative review of attendance log)
2. To evaluate the diversity of patients included in each pathways through evaluation of sociodemographic and economic profile (Socioeconomic and demographic self-reported questionnaire)
3. To evaluate the impact of each pathway and each supportive care intervention on patient's overall health status (EQ-E5-EL)
4. To evaluate the impact of each pathway and each supportive care intervention on patient's quality of life (EORTC QLQ C30)
5. To evaluate the impact of each pathway and each supportive care intervention on symptom burden (MDASI)
6. To evaluate the impact of each pathway and each supportive care intervention on anxiety (HADS)
7. To evaluate the impact of each pathway and each supportive care intervention on Insomnia levels (ISI)
8. To evaluate the impact of each pathway and each supportive care intervention on sexual health (EORTC SHQ-C22)
9. To evaluate the Physician's Adoption of each pathway through the proportion of physicians referring patients to the pathways (referral log)
10. To evaluate patient's adoption through the proportion of patients adhering to supportive care interventions as intended (attendance log)
11. To evaluate patient experience and satisfaction with the pathways (PACIC and adhoc satisfaction questionnaires.
12. To evaluate implementation in through a qualitative analyses of experience, implementation barriers and facilitators (focus groups with patients and providers)
13. To plan for Maintenance of the pathway through a cost effectiveness analysis.
14. To evaluate the impact of each pathway and each supportive care intervention on Intestinal Symptoms (LARS score). if indicated for the specific population
15. To evaluate the impact of each pathway and each supportive care intervention on Anal Incontinence (Wexner score). if indicated for the specific population
16. To evaluate the impact of each pathway and each supportive care intervention on Urinary Symptoms (USP score). if indicated for the specific population
17. To evaluate the impact of each pathway and each supportive care intervention on Hematologic Cancer (FACT-BMT)
18. To evaluate the impact of each pathway and each supportive care intervention on Montgomery Borgatta Caregiver Burden Scale. if indicated for the specific population.
19. To evaluate the healthcare professionals participating in the pathway to screen vulnerability and prevent treatment related burden (F-SUS)

This is a master protocol study that is conducted by collecting sub-studies for each supportive care intervention which share key design components and operational aspects leading to a higher level of coordination than the one achieved by independently conducted studies.

Methodology: it is a mix of quantitative and qualitative methods to assess the Reach, Efficacy and potential for Adoption, while identifying barriers to Implementation and strategies to Maintain the pathway in the institution guided by the RE-AIM framework. Data collection will allow evaluation in a macro level (integrated supportive care pathway including supportive care needs assessment and tailored multidisciplinary referrals) and in a micro level (separated for each supportive care intervention).

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Maria Alice BORINELLI-FRANZOI; Phone Number: +33 (0)1 42 11 42 11; Email: Mariaalice.BORINELLI-FRANZOI@gustaveroussy.fr
• Study Contact Backup: Name: Aude BARBIER; Phone Number: +33 (0)6 44 12 47 75; Email: aude.barbier@gustaveroussy.fr

Study Locations

• France
  • Villejuif, France, 94800
    • Recruiting
    • Gustave Roussy
    • Contact: Ines VAZ LUIS; Email: INES-MARIA.VAZ-DUARTE-LUIS@gustaveroussy.fr
    • Contact: Aude BARBIER; Email: aude.barbier@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with any cancer type, any stage receiving supportive care interventions at Gustave Roussy.

For the primary endpoint all the patients participating in supportive care pathways with formal supportive care needs assessment and targeted referrals will be invited to participate. For the secondary endpoints, any patient included in the supportive care interventions at the institution may participate.

Description

Inclusion Criteria:

• Histological confirmation of cancer (any cancer type, any stage)
• Age ≥ 18 years old
• Received an integrated supportive care need assessment.
• Sign the consent form for the PROACT study.

Exclusion Criteria:

• Absence or inability of written consent from the patient.
• Does not understand or speak French.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PROACT Supportive Care pathways; This is a prospective cohort study including patients participating in institutional supportive care pathways at diagnosis, during treatment and after treatment.	Other: Supportive Care Pathway; All pathways include a medical consultation with comprehensive needs assesment and evidence-based coordinated supportive care referrals at institutional and community-based level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient distress	Patient distress collected with NCCN Distress Thermometer	over a 12-week period after the integrated supportive care needs assessment.
Patient unmet needs	Patient unmet needs collected with problem list from NCCN Distress thermometer	over a 12-week period after the integrated supportive care needs assessment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach of the pathway	Proportion of patients who accepted the supportive care needs assessment (descriptive numbers from attendance log)	week 12
Diversity of pathway participants	Socioeconomic characteristics of participants in the pathway measure by a self-reported socioeconomic questionnaire	week 12
Impact of the pathway in overall health status	Overall health status measured by the EQ-ED-5L	week 12, and 24
Impact of the pathway in Quality of life	Quality of life measured by the EORTC QLQ C30	week 12, and 24
Impact of the pathway in symptom burden	Symptom burden measured by the MDASI Questionnaire.	week 12, and 24
Impact of the pathway on anxiety levels	Anxiety measured by HADS * only for patients reporting anxiety at baseline	week 12, and 24
Impact of the pathway on insomnia levels	Insomnia measured by ISI *only for patients reporting insomnia at baseline	week 12, and 24
Impact of the pathway on sexual health	Sexual health measured by EORTC SHQ-C22 *only for patients reporting sexual dysfunction at baseline	week 12, and 24
Adoption of Physician	Proportion of physicians referring patients to the supportive care pathway (descriptive numbers from referral logs)	week 12
Adoption of Patient	Proportion and of patients that fully adopted each supportive care intervention (e.g.; in the after cancer pathway: attendance to consultations/seminaries/classes, completion of a supportive care program, usage data for Resilience app).	week 12
Patient Experience	Patient experience measured by the PACIC questionnaire.	week 12
Patient Satisfaction with the pathway	Patient satisfaction measured by an ad hoc satisfaction questionnaire	week 12
Provider Experience - Qualitative evaluation	Focus groups with healthcare providers to explore overall experience, workload and implementation challenges	week 12
Patient Satisfaction/Experience - Qualitative evaluation	Focus groups with patient to explore overall experience and implementation challenges	week 12
Maintenance of the pathway through a cost effectiveness analysis (QALYs)	Maintenance of the pathway through a cost effectiveness analysis. Costs from the perspective of the French national health insurance will be assessed during the study period. This will be calculated by administrative data review of internal allocated resources for pathway delivery and estimated costs of use of hospital services (unplanned hospitalization, consultations, and emergency visits recorded in the electronic medical records). QALYs (quality-adjusted life years) will be measured using utility values derived from the EuroQol-5D (EQ-5D-5L) (https://euroqol.org/) for French general population (Andrade et al. PharmacoEconomics 2020). QALYs will be computed combining survival time by utility values.	week 12
Impact of the pathway on Intestinal Symptom	Intestinal Symptoms measured by LARS score. *only for patients with digestive cancer	week 24
Impact of the pathway on Anal incontinence	Anal incontinence measured by Wexner score. *only for patients with digestive cancer	week 24
Impact of the pathway on Urinary symptoms	Urinary symptoms measured by USP score. *only for patients with digestive cancer	week 24
Impact of the pathway on Functional Assessment of Cancer Therapy-Bone Marrow Transplant	Functional Assessment of Cancer Therapy-Bone Marrow Transplant measured by FACT-BMT score. *only for patients with Hematologic Cancer	week 12, week 24
Impact of the pathway on caregiver burden	Caregiver burden measured by Montgomery Borgatta Caregiver Burden Scale.	week 12
Impact of the pathway on healthcare professionals participating in the pathway to screen vulnerability and prevent treatment	Healthcare professionals measured by F-SUS Score	week 12

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Investigators: Principal Investigator: Ines VAZ LUIS, Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

General Publications

• Franzoi MA, Santolaya C, Martin E, Fasse L, Rouby P, Minot-This MS, Di Meglio A, Vaz-Luis I. "Let's talk about risk": co-designing a pathway to assess, communicate and act on individual risk of long-term toxicities after breast cancer. J Cancer Surviv. 2025 Jun 12. doi: 10.1007/s11764-025-01826-0. Online ahead of print.
• Franzoi MA, Pages A, Papageorgiou L, Di Meglio A, Laparra A, Martin E, Barbier A, Renvoise N, Arvis J, Scotte F, Vaz-Luis I. Evaluating the Implementation of Integrated Proactive Supportive Care Pathways in Oncology: Master Protocol for a Cohort Study. JMIR Res Protoc. 2024 Aug 26;13:e52841. doi: 10.2196/52841.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: cancer; supportive care; Distress; master protocol; supportive care pathway
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2023-A01225-40; 2023/3662 (Other Identifier: CSET number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No