Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-17 @ 3:38 AM
Study NCT ID:
NCT06479057
Status:
RECRUITING
Last Update Posted:
2024-07-29
First Post:
2024-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROACT is a Prospective Master Protocol for a Cohort Study Focused on Evaluating the Implementation of Integrated Proactive Supportive Care Pathways at Gustave Roussy
Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Organization:
Study Overview
Official Title:
Integrating PROACTive Care Pathways to Empower and Support Cancer Patients (PROACT)
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROACT
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.
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023/3662 | OTHER | CSET number | View |