Colon CancerPASSIONNCT04235556
Integrated Care Pathway in Oncology (PASSION)
An observational study of Colon Cancer and Gastric Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A centralized unit for integrated management of care pathway in Oncology has been created. This unit settles the patients' appointments (biopsy, intravenous device, chemotherapy, imaging, oncologist...). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer, Gastric Cancer, Pancreatic Cancer
- What is being tested?
- Care pathway unit
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,800 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective cohort: patients treated at the Hôpital Européen Georges Pompidou in 2015 and 2017. Prospective cohort: * Histologically proven : colon, gastric, pancreatic, prostate, bladder, breast, thoracic, or ovarian cancer * First appointment for cancer care at the Hôpital Européen Georges Pompidou * Ile de France resident * All appointments planned at the Hôpital Européen Georges Pompidou * Intravenous antitumoral treatment
Who may be able to join
- Histologically proven : colon, gastric, pancreatic, prostate, bladder, breast, thoracic, or ovarian cancer
- First appointment for cancer care at the Hôpital Européen Georges Pompidou
- Intravenous antitumoral treatment
Who cannot join
- Medical care non covered by social welfare
- Radiochemotherapy
- Death in the 6 months following first oncological appointment or absence of medical care in the year following the first oncological appointment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Management of Care Pathway in Oncology. Impact on the Delay of Therapeutic Management and the Satisfaction of Patients and Carers
A centralized unit for integrated management of care pathway in Oncology has been created. This unit settles the patients' appointments (biopsy, intravenous device, chemotherapy, imaging, oncologist...).
The aim of this study is to assess the delay between the first appointment with the oncologist and the beginning of the antitumoral treatment, and therefore evaluate the efficacy of the care pathway unit.
The second aim is to assess the satisfaction of patients and health care teams.
Read the detailed description
PASSION is a french monocentric study.
For the retrospective cohort, patient will be selected through the use of data warehouse available on the HEGP.
For the prospective cohort, patient will be included according to the selection criteria.
Each patient will be followed up during 6 month and a satisfaction questionnaire will be completed at 1 month and 4 month of the first administration of anti-tumor therapy.
For both cohort, clinical-anatomo-biological data will be collected through the use of data warehouse available on the HEGP.
- Conditions
- Colon Cancer, Gastric Cancer, Pancreatic Cancer, Thoracic Neoplasms, Breast Cancer, Ovarian Cancer
- Being tested
- Care pathway unit
- Keywords
- care pathway, satisfaction, oncology, treatment delay
- Medical subject headings
- Colonic Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Thoracic Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Urinary Bladder Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care pathway unitBehavioural
Patients from the prospective cohort will have their health care scheduled by the care pathway unit.
| Study group | Role | What they receive |
|---|---|---|
| Historic cohort | Retrospective cohort of patients that were treated in the Hôpital Européen Georges Pompidou before the creation of the care pathway unit. | |
| Prospective cohort | All consecutive patients that meet the inclusion criterion and will begin a cancer care after the study start. Receives: Behavioral: Care pathway unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time between the first appointment with the oncologist and the beginning of antitumoral treatment.
Delay of health care
Measured: 6 months
Secondary outcomes (3)
Patients satisfaction
Satisfaction of patients with OUT-PATSAT35 questionnaire (out-patient satisfaction) : Likert type scale with 5 ordered modalities (bad to excellent), rated from 1 to 5.
Measured: 6 months
Health care teams satisfaction
Satisfaction of health care teams : qualitative questionnaire with 4 ordered modalities (very satisfied to not satisfied)
Measured: 6 months
Rate of emergency consultations and hospitalizations
Need for unexpected health care
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start21 Feb 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- MSD France
- Responsible party
- Sponsor
- Investigators
- Virginie Bichon, Principal investigator, AP-HP, Hôpital Européen Georges Pompidou, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235556
- Sponsor's protocol ID
- APHP190973
- Acronym
- PASSION
- Status last verified
- May 2022
- First submitted
- 2 Dec 2019
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Management of Care Pathway in Oncology. Impact on the Delay of Therapeutic Management and the Satisfaction of Patients and Carers
- ClinicalTrials.gov ID
- NCT04235556
- Acronym / sponsor ID
- PASSION / APHP190973
- Conditions
- Colon Cancer, Gastric Cancer, Pancreatic Cancer, Thoracic Neoplasms, Breast Cancer, Ovarian Cancer
- Keywords
- care pathway, satisfaction, oncology, treatment delay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- MSD France
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A centralized unit for integrated management of care pathway in Oncology has been created. This unit settles the patients' appointments (biopsy, intravenous device, chemotherapy, imaging, oncologist...).
The aim of this study is to assess the delay between the first appointment with the oncologist and the beginning of the antitumoral treatment, and therefore evaluate the efficacy of the care pathway unit.
The second aim is to assess the satisfaction of patients and health care teams.
Detailed description
PASSION is a french monocentric study.
For the retrospective cohort, patient will be selected through the use of data warehouse available on the HEGP.
For the prospective cohort, patient will be included according to the selection criteria.
Each patient will be followed up during 6 month and a satisfaction questionnaire will be completed at 1 month and 4 month of the first administration of anti-tumor therapy.
For both cohort, clinical-anatomo-biological data will be collected through the use of data warehouse available on the HEGP.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Historic cohort | – | –Retrospective cohort of patients that were treated in the Hôpital Européen Georges Pompidou before the creation of the care pathway unit. |
| Prospective cohort | – | Behavioral: Care pathway unitAll consecutive patients that meet the inclusion criterion and will begin a cancer care after the study start. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective cohort: patients treated at the Hôpital Européen Georges Pompidou in 2015 and 2017. Prospective cohort: * Histologically proven : colon, gastric, pancreatic, prostate, bladder, breast, thoracic, or ovarian cancer * First appointment for cancer care at the Hôpital Européen Georges Pompidou * Ile de France resident * All appointments planned at the Hôpital Européen Georges Pompidou * Intravenous antitumoral treatment
Key inclusion criteria (3 listed)
- Histologically proven : colon, gastric, pancreatic, prostate, bladder, breast, thoracic, or ovarian cancer
- First appointment for cancer care at the Hôpital Européen Georges Pompidou
- Intravenous antitumoral treatment
Key exclusion criteria (3 listed)
- Medical care non covered by social welfare
- Radiochemotherapy
- Death in the 6 months following first oncological appointment or absence of medical care in the year following the first oncological appointment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care pathway unitPatients from the prospective cohort will have their health care scheduled by the care pathway unit. | Behavioural | Prospective cohort |
Primary outcome
Time between the first appointment with the oncologist and the beginning of antitumoral treatment.
Time frame: 6 months
Delay of health care
3 secondary outcomes
Patients satisfaction
Time frame: 6 months
Health care teams satisfaction
Time frame: 6 months
Rate of emergency consultations and hospitalizations
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginie Bichon principal investigator
AP-HP, Hôpital Européen Georges Pompidou, Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Gastric Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time between the first appointment with the oncologist and the beginning of antitumoral treatment. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022; AzTrials last refreshed its copy on 31 Oct 2026.