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

ConditionAny Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGustave Roussy, Cancer Campus, Grand Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Absence or inability of written consent from the patient.

Does not understand or speak French.

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Supportive Care Pathway

    Other intervention

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

Treatment groups

700 Participants
are divided into 1 treatment group
Group A: PROACT Supportive Care pathways1 intervention

Trial outcomes

Primary outcomes

1

Patient distress

Patient distress collected with NCCN Distress Thermometer

Time frame
over a 12-week period after the integrated supportive care needs assessment.
2

Patient unmet needs

Patient unmet needs collected with problem list from NCCN Distress thermometer

Time frame
over a 12-week period after the integrated supportive care needs assessment.

Secondary outcomes

1

Reach of the pathway

Proportion of patients who accepted the supportive care needs assessment (descriptive numbers from attendance log)

Time frame
week 12
2

Diversity of pathway participants

Socioeconomic characteristics of participants in the pathway measure by a self-reported socioeconomic questionnaire

Time frame
week 12
3

Impact of the pathway in overall health status

Overall health status measured by the EQ-ED-5L

Time frame
week 12, and 24
4

Impact of the pathway in Quality of life

Quality of life measured by the EORTC QLQ C30

Time frame
week 12, and 24

Other outcomes

Sponsors and contacts

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