AdenocarcinomaPANTELONCT04667403
Telemedicine in the Management of Pain in Patients With Advanced or Metastatic Pancreatic Cancer
A study testing Telemedicine in people with Adenocarcinoma and Pancreatic Cancer Metastatic, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
Adenocarcinoma of the pancreas is a major public health issue because of its disastrous prognosis. The symptomatology of locally advanced or metastatic forms, particularly painful, is often major and difficult to balance, impacting both the quality of life of patients (and those around them) and the course of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma, Pancreatic Cancer Metastatic, Pain
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2022to 8 Feb 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 years old ;
- Patient with histologically or cytologically proven locally advanced and/or metastatic adenocarcinoma of the pancreas;
- Patient undergoing or failing medical treatment and comfort care only;
- Patient with EVA ≥ 4 and/or requiring analgesics level 3;
- Performans Status (ECOG) < 3 ;
- Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator;
- Patient affiliated or beneficiary of the social security system
Who cannot join
- Patient does not have a smartphone, tablet or computer;
- Patient with no personal internet access at home (WIFI, wired), or via his smartphone;
- Patient does not feel able to fill out an electronic questionnaire;
- Patient cannot read or write French;
- Patient does not speak and understand French;
- Persons deprived of liberty or under guardianship or trusteeship ;
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- Dementia, mental alteration or psychiatric pathology that could compromise the patient's informed consent and/or compliance with the protocol and follow-up of the trial ;
- Inability to submit to trial protocol follow-up for geographical, social, or other reasons ;
- Patient participating in another interventional study evaluating treatment and pain management.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
ICO site St HERBLAIN
Saint-Herblain, 44805
Julia QUINTIN, MD, julia.quintin@ico.unicancer.fr
Julia QUINTIN, MD
About this study
Adenocarcinoma of the pancreas is a major public health issue because of its disastrous prognosis. The symptomatology of locally advanced or metastatic forms, particularly painful, is often major and difficult to balance, impacting both the quality of life of patients (and those around them) and the course of treatment (chemotherapy).
The objective of this study is to evaluate the interest and feasibility of telemedicine in the management of pain in patients undergoing treatment for advanced or metastatic pancreatic cancer.
- Conditions
- Adenocarcinoma, Pancreatic Cancer Metastatic, Pain
- Being tested
- Telemedicine
- Keywords
- telemedicine
- Medical subject headings
- Adenocarcinoma, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
In addition to his standard follow-up, the patient benefits from a home follow-up of his pain for 6 months from his inclusion in the study.
The patient has to log on via the application, every week. to fill in the questionnaire to evaluate the pain over the past week.
The questionnaire consists of 4 questions to which the patient answers using a numerical scale from 0 to 10.
If the patient's pain is not controlled, the patient can log on in "emergency" mode as many times as he or she deems necessary.
A nurse path coordinator will be informed of each connection. Depending on the type of alert received, she may initiate a telephone consultation with the oncologist or pain specialist:
- If necessary within 24 hours of the connection if it is a weekly connection,
- Systematic within 3 hours if it is an emergency connection or if the data entered at the time of the weekly connection requires medical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Experimental | Pain is monitored, from the patient's home, using a computer application accessible from a smartphone or a computer with internet access.
This application will allow the patient to describe his or her pain by means of a self-questionnaire. Healthcare professionals (nurse coordinator, pain specialist and oncologist) will thus be able to remotely interpret the data collected, enabling them to provide patients with a rapid response to adapt their pain treatment without the patient having to travel to the establishment. Receives: Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction of patients with advanced or metastatic pancreatic cancer of the impact of telemedicine in the management of their pain.
Satisfaction is measured using the Patient Global Clinical Impression of Change (P-GIC) questionnaire.
The questionnaire consists of a single question posed to the patient via the application asking the patient what impact he or she believes telemedicine has had on the overall management of his or her pain. The patient has the following 8 propositions among which he must indicate the one that best corresponds to the perceived change: Don't know, Very strongly positive, Strongly positive, Slightly positive, No change, Slightly negative, Strongly negative, Very strongly negative.
Measured: at one month, 3 months and 6 months post-inclusion
Secondary outcomes (4)
Observed feasibility of telemedicine
Feasibility will be assessed by collecting :
Number of weekly connections actually made and validated up to 3 months post -inclusion.
Number of weekly connections actually made and not validated up to 3 months post-inclusion.
Number of emergency connections actually made and validated up to 3 months post-inclusion.
Number of emergency connections actually made and not validated up to 3 months post-inclusion.
A validated connection means that the patient has answered all the questions defined for the type of weekly or emergency connection chosen and that the application has acknowledged the connection.
Measured: 3 months post-inclusion.
Satisfaction of healthcare professionals with the use of telemedicine in the management of patients' pain.
Satisfaction is measured using the healthcare professionals Global Clinical Impression of Change (C-GIC) questionnaire. The questionnaire includes a single question asked to the medical staff taking care of the patient (Nurse pathway coordinators and oncologists or algologists) asking them to estimate the impact of telemedicine on the overall pain management of patients. They are given the following 8 propositions, among which they must indicate the one that best corresponds to the perceived change: Don't know, Very strongly positive, Strongly positive, Slightly positive, No change, Slightly negative, Strongly negative, Very strongly negative.
Measured: at 6 months post-inclusion
Number of "unscheduled" consultations recorded of each patient.
Measured: at 3 months and 6 months post-inclusion
Number of unscheduled hospitalizations recorded of each patient.
Measured: at 3 months and 6 months post-inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start7 Feb 2022
- Primary completion8 Nov 2023 (estimated)
- Study completion8 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia QUINTIN, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667403
- Sponsor's protocol ID
- ICO-2020-13
- Acronym
- PANTELO
- Status last verified
- Apr 2022
- First submitted
- 1 Dec 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine in the Management of Pain in Patients With Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04667403
- Acronym / sponsor ID
- PANTELO / ICO-2020-13
- Conditions
- Adenocarcinoma, Pancreatic Cancer Metastatic, Pain
- Keywords
- telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 8 Nov 2023 (estimated)
- Study completion
- 8 Feb 2024 (estimated)
- First posted
- 14 Dec 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.
Adenocarcinoma of the pancreas is a major public health issue because of its disastrous prognosis. The symptomatology of locally advanced or metastatic forms, particularly painful, is often major and difficult to balance, impacting both the quality of life of patients (and those around them) and the course of treatment (chemotherapy).
The objective of this study is to evaluate the interest and feasibility of telemedicine in the management of pain in patients undergoing treatment for advanced or metastatic pancreatic cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Other: TelemedicinePain is monitored, from the patient's home, using a computer application accessible from a smartphone or a computer with internet access. This application will allow the patient to describe his or her pain by means of a self-questionnaire. Healthcare professionals (nurse coordinator, pain specialist and oncologist) will thus be able to remotely interpret the data collected, enabling them to provide patients with a rapid response to adapt their pain treatment without the patient having to travel to the establishment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient ≥ 18 years old ;
- Patient with histologically or cytologically proven locally advanced and/or metastatic adenocarcinoma of the pancreas;
- Patient undergoing or failing medical treatment and comfort care only;
- Patient with EVA ≥ 4 and/or requiring analgesics level 3;
- Performans Status (ECOG) < 3 ;
Key exclusion criteria (9 listed)
- Patient does not have a smartphone, tablet or computer;
- Patient with no personal internet access at home (WIFI, wired), or via his smartphone;
- Patient does not feel able to fill out an electronic questionnaire;
- Patient cannot read or write French;
- Patient does not speak and understand French;
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 |
|---|---|---|
| TelemedicineIn addition to his standard follow-up, the patient benefits from a home follow-up of his pain for 6 months from his inclusion in the study. The patient has to log on via the application, every week. to fill in the questionnaire to evaluate the pain over the past week. The questionnaire consists of 4 questions to which the patient answers using a numerical scale from 0 to 10. If the patient's pain is not controlled, the patient can log on in "emergency" mode as many times as he or she deems necessary. A nurse path coordinator will be informed of each connection. Depending on the type of alert received, she may initiate a telephone consultation with the oncologist or pain specialist: * If necessary within 24 hours of the connection if it is a weekly connection, * Systematic within 3 hours if it is an emergency connection or if the data entered at the time of the weekly connection requires medical intervention. | Other | Telemedicine |
Primary outcome
Satisfaction of patients with advanced or metastatic pancreatic cancer of the impact of telemedicine in the management of their pain.
Time frame: at one month, 3 months and 6 months post-inclusion
Satisfaction is measured using the Patient Global Clinical Impression of Change (P-GIC) questionnaire. The questionnaire consists of a single question posed to the patient via the application asking the patient what impact he or she believes telemedicine has had on the overall management of his or her pain. The patient has the following 8 propositions among which he must indicate the one that best corresponds to the perceived change: Don't know, Very strongly positive, Strongly positive, Slightly positive, No change, Slightly negative, Strongly negative, Very strongly negative.
4 secondary outcomes
Observed feasibility of telemedicine
Time frame: 3 months post-inclusion.
Satisfaction of healthcare professionals with the use of telemedicine in the management of patients' pain.
Time frame: at 6 months post-inclusion
Number of "unscheduled" consultations recorded of each patient.
Time frame: at 3 months and 6 months post-inclusion
Number of unscheduled hospitalizations recorded of each patient.
Time frame: at 3 months and 6 months post-inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Julia QUINTIN, MD principal investigator
Institut de Cancérologie de l'Ouest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Adenocarcinoma and Pancreatic Cancer Metastatic, run by Institut Cancerologie de l'Ouest 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 7 inclusion and 9 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 28 Apr 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?
Contact Julia QUINTIN, MD (02 40 67 99 33 ext. +33, julia.quintin@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction of patients with advanced or metastatic pancreatic cancer of the impact of telemedicine in the management of their pain. (time frame: at one month, 3 months and 6 months post-inclusion). 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 28 Apr 2022.