Clinical trial NCT06479057: PROACT is a Prospective Master Protocol for a Cohort Study Focused on Evaluating the Implementation of Integrated Proactive Supportive Care Pathways at Gustave Roussy
Official title: Integrating PROACTive Care Pathways to Empower and Support Cancer Patients (PROACT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Any Cancer
Keywords: supportive care pathway
cancer
master protocol
supportive care
Distress
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: The primary study endpoint of PROACT is patient distress and supportive care needs (NCCN Distress Thermometer and NCCN Problem list) over a 12-week period after the supportive care needs assessment and referrals in the context of a PROACT pathway.

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Patient distress
timeFrame: over a 12-week period after the integrated supportive care needs assessment.
measure: Patient unmet needs
timeFrame: over a 12-week period after the integrated supportive care needs assessment.
Secondary outcomes:
measure: Reach of the pathway
timeFrame: week 12
measure: Diversity of pathway participants
timeFrame: week 12
measure: Impact of the pathway in overall health status
timeFrame: week 12, and 24
measure: Impact of the pathway in Quality of life
timeFrame: week 12, and 24
measure: Impact of the pathway in symptom burden
timeFrame: week 12, and 24
measure: Impact of the pathway on anxiety levels
timeFrame: week 12, and 24
measure: Impact of the pathway on insomnia levels
timeFrame: week 12, and 24
measure: Impact of the pathway on sexual health
timeFrame: week 12, and 24
measure: Adoption of Physician
timeFrame: week 12
measure: Adoption of Patient
timeFrame: week 12
measure: Patient Experience
timeFrame: week 12
measure: Patient Satisfaction with the pathway
timeFrame: week 12
measure: Provider Experience - Qualitative evaluation
timeFrame: week 12
measure: Patient Satisfaction/Experience - Qualitative evaluation
timeFrame: week 12
measure: Maintenance of the pathway through a cost effectiveness analysis (QALYs)
timeFrame: week 12
measure: Impact of the pathway on Intestinal Symptom
timeFrame: week 24
measure: Impact of the pathway on Anal incontinence
timeFrame: week 24
measure: Impact of the pathway on Urinary symptoms
timeFrame: week 24
measure: Impact of the pathway on Functional Assessment of Cancer Therapy-Bone Marrow Transplant
timeFrame: week 12, week 24
measure: Impact of the pathway on caregiver burden
timeFrame: week 12
measure: Impact of the pathway on healthcare professionals participating in the pathway to screen vulnerability and prevent treatment
timeFrame: week 12
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Ines VAZ LUIS
role: PRINCIPAL_INVESTIGATOR
References: