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 Number: NCT06479057
Acronym: PROACT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Any Cancer
Interventions: OTHER: Supportive Care Pathway
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 210
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-11
Completion Date: 2025-11
Locations: Gustave Roussy, Villejuif, 94800, France

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.

Primary Outcome Measures: 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: 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