PROACT is a Prospective Master Protocol for a Cohort Study Focused on Evaluating the Implementation of Integrated Proactive Supportive Care Pathways at Gustave Roussy
NCT ID: NCT06479057
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
700 participants
OBSERVATIONAL
2024-01-11
2027-07-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old
* Received an integrated supportive care need assessment.
* Sign the consent form for the PROACT study.
Exclusion Criteria
* Does not understand or speak French.
18 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Principal Investigators
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Ines VAZ LUIS
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Gustave Roussy
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2023/3662
Identifier Type: OTHER
Identifier Source: secondary_id
2023-A01225-40
Identifier Type: -
Identifier Source: org_study_id
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