NCT06479057

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2024Jul 2027

Study Start

First participant enrolled

January 11, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

April 5, 2024

Last Update Submit

January 15, 2026

Conditions

Any Cancer

Keywords

supportive care pathwaycancermaster protocolsupportive careDistress

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (21)

  • Reach of the pathway

    week 12

  • Diversity of pathway participants

    week 12

  • Impact of the pathway in overall health status

    week 12, and 24

  • Impact of the pathway in Quality of life

    week 12, and 24

  • Impact of the pathway in symptom burden

    week 12, and 24

  • +16 more secondary outcomes

Study Arms (1)

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

Interventions

Supportive Care PathwayOTHER

All pathways include a medical consultation with comprehensive needs assesment and evidence-based coordinated supportive care referrals at institutional and community-based level.

PROACT Supportive Care pathways

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy

Villejuif, 94800, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 40504480DERIVED

  • 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.

    PMID: 39186774DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Ines VAZ LUIS

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Alice BORINELLI-FRANZOI

CONTACT

+33 (0)1 42 11 42 11Mariaalice.BORINELLI-FRANZOI@gustaveroussy.fr

Aude BARBIER

CONTACT

+33 (0)6 44 12 47 75aude.barbier@gustaveroussy.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2024

First Posted

June 27, 2024

Study Start

January 11, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations

FR(1)