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 volunteersQualifiers
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
Other
Prospective
Treatments tested in this trial
Supportive Care Pathway
Other interventionAll pathways include a medical consultation with comprehensive needs assesment and evidence-based coordinated supportive care referrals at institutional and community-based level.
Treatment groups
Trial outcomes
Primary outcomes
Patient distress
Patient distress collected with NCCN Distress Thermometer
Patient unmet needs
Patient unmet needs collected with problem list from NCCN Distress thermometer
Secondary outcomes
Reach of the pathway
Proportion of patients who accepted the supportive care needs assessment (descriptive numbers from attendance log)
Diversity of pathway participants
Socioeconomic characteristics of participants in the pathway measure by a self-reported socioeconomic questionnaire
Impact of the pathway in overall health status
Overall health status measured by the EQ-ED-5L
Impact of the pathway in Quality of life
Quality of life measured by the EORTC QLQ C30
Sponsors and contacts
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