Colon CancerNCT04316078
A Novel Patient Engagement Platform Among Patients With Gastrointestinal Malignancies
A study testing patient engagement platform in people with Colon Cancer and Gastric Cancer, run by Sheba Medical Center at 1 site in Israel.
Trial summary
A randomized control trial to evaluate the feasibility of implementing a patient educational platform (PEP) for patients with gastrointestinal malignancies undergoing active chemotherapy treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer, Gastric Cancer, Pancreas Cancer
- What is being tested?
- patient engagement platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Mar 2020to 15 Apr 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals with a newly diagnosed gastrointestinal malignancy, treated at the outpatient clinic of the Institute of Oncology at the Sheba Medical Center
- Individuals planned to receive one of the following cytotoxic chemotherapy protocols:
- FOLFOX - a combination of 5-fluoruracil, leucovorin and oxaliplatin.
- FOLFOIRI - a combination of 5-fluoruracil, leucovorin and irinotecan.
- FOLFIRINOX - a combination of 5-fluoruracil, leucovorin, oxaliplatin and irinotecan.
- De Gramont - 5-fluoruracil and leucovorin.
- Ability to read and comprehend Hebrew language text.
- Ability to see computer or cell phone screen (i.e., no visual impairment).
Who cannot join
- Eastern Conference Oncology Group (ECOG) performance status greater than 2.
- Cognitive deficits that would preclude understanding of consent form and/or questionnaires.
- Inability to read and comprehend Hebrew language text.
- Current participation in a therapeutic clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Patient Engagement Platform Used to Improve Understanding, Treatment Compliance and Quality of Care Among Patients With Gastrointestinal Malignancies
A randomized control trial to evaluate the feasibility of implementing a patient educational platform (PEP) for patients with gastrointestinal malignancies undergoing active chemotherapy treatment.
Read the detailed description
Patients will be randomized in a 2:1 ratio.
Patients in the experimental arm will receive automatically generated personalized educational videos (PEV) and questionnaires regarding side effects and quality of life (QOL) to either their cell phone or email. The videos will be personalized to each patient based on their demographics, specific medical instructions and treatment plan. Data collected regarding side effects and QOL in the experimental arm will be used in order to facilitate real time intervention through real time provider alert system.
A link to the first PEV will be sent before the first chemotherapy cycle, addressing the diagnosis and type of malignancy, chemotherapy protocol, common side effects and their management. Side effects questionnaire will be sent every week while QOL questionnaire will be sent every 6 weeks.
Patients will be followed from recruitment through three weeks after completion of the planned treatment protocol. If treatment is discontinued prior to completion of the protocol, follow-up will end three weeks after the last administered treatment.
- Conditions
- Colon Cancer, Gastric Cancer, Pancreas Cancer, Rectal Cancer, Cholangiocarcinoma, Small Bowel Cancer
- Being tested
- patient engagement platform
- Keywords
- patient reported outcome, quality of life, personalized videos
- Medical subject headings
- Colonic Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Rectal Neoplasms, Cholangiocarcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient engagement platformOther
- Allows patients to receive the action plan as educational videos on demand.
- Allows patients to report side effects and quality of life via questionnaires and receive immediate targeted education based on the predefined action plan.
| Study group | Role | What they receive |
|---|---|---|
| personalized engagement platform | Experimental | Patients registered into personalized engagement platform (PEP) will receive personalized educational videos (PEV) according to disease, treatment protocol and side effects. Receives: Other: patient engagement platform |
| control group | No intervention | The control group will not be registered to the PEP nor receive any PEVs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of PEP (percent of patients using videos/complete questionnaires)
To assess the feasibility of implementing a PEP in the outpatient gastrointestinal malignancies service, at Sheba Medical Center, for patients undergoing active chemotherapy treatment. This outcome will be measured as percent of patients using the videos and percent of patients that complete the questionnaires.
Measured: 3 years
Secondary outcomes (4)
Secondary clinical outcomes 1 (mean number of referrals)
To monitor mean number of referrals to emergency room and admissions to the inpatient department.
Measured: 3 years
Secondary clinical outcomes 2 (level of chemotoxicity)
To measure level of chemotoxicity - Neuropathy, diarrhea, nausea and vomiting, stomatitis and fever; using total number and percent of patients with side effects in each arm and Common Terminology Criteria for side effects (CTCAE) grading scale.
Measured: 3 years
Secondary clinical outcomes 3 (Quality of Life)
To measure patient assessment of Quality of Life (QoL) using a validated questionnaire (QLQ-C30).
Measured: 3 years
Secondary clinical outcomes 4 (treatment intensity and continuity)
To evaluate treatment intensity and continuity measured as number of chemotherapy cycles and cumulative chemotherapy dose.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start15 Mar 2020
- Primary completion15 Jul 2021
- Study completion15 Apr 2022
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 Sheba Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control study (2:1 allocation)
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ofer Margali, MD PhD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316078
- Sponsor's protocol ID
- SHEBA-19-6013-YL-CTIL
- Status last verified
- Mar 2020
- First submitted
- 23 Feb 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- A Novel Patient Engagement Platform Used to Improve Understanding, Treatment Compliance and Quality of Care Among Patients With Gastrointestinal Malignancies
- ClinicalTrials.gov ID
- NCT04316078
- Acronym / sponsor ID
- SHEBA-19-6013-YL-CTIL
- Conditions
- Colon Cancer, Gastric Cancer, Pancreas Cancer, Rectal Cancer, Cholangiocarcinoma, Small Bowel Cancer
- Keywords
- patient reported outcome, quality of life, personalized videos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 20 Mar 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 randomized control trial to evaluate the feasibility of implementing a patient educational platform (PEP) for patients with gastrointestinal malignancies undergoing active chemotherapy treatment.
Detailed description
Patients will be randomized in a 2:1 ratio.
Patients in the experimental arm will receive automatically generated personalized educational videos (PEV) and questionnaires regarding side effects and quality of life (QOL) to either their cell phone or email. The videos will be personalized to each patient based on their demographics, specific medical instructions and treatment plan. Data collected regarding side effects and QOL in the experimental arm will be used in order to facilitate real time intervention through real time provider alert system.
A link to the first PEV will be sent before the first chemotherapy cycle, addressing the diagnosis and type of malignancy, chemotherapy protocol, common side effects and their management. Side effects questionnaire will be sent every week while QOL questionnaire will be sent every 6 weeks.
Patients will be followed from recruitment through three weeks after completion of the planned treatment protocol. If treatment is discontinued prior to completion of the protocol, follow-up will end three weeks after the last administered treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control study (2:1 allocation)
| Arm | Type | Receives |
|---|---|---|
| personalized engagement platform | Experimental | Other: patient engagement platformPatients registered into personalized engagement platform (PEP) will receive personalized educational videos (PEV) according to disease, treatment protocol and side effects. |
| control group | No intervention | –The control group will not be registered to the PEP nor receive any PEVs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals with a newly diagnosed gastrointestinal malignancy, treated at the outpatient clinic of the Institute of Oncology at the Sheba Medical Center
- Individuals planned to receive one of the following cytotoxic chemotherapy protocols:
- Ability to read and comprehend Hebrew language text.
- Ability to see computer or cell phone screen (i.e., no visual impairment).
Key exclusion criteria (4 listed)
- Eastern Conference Oncology Group (ECOG) performance status greater than 2.
- Cognitive deficits that would preclude understanding of consent form and/or questionnaires.
- Inability to read and comprehend Hebrew language text.
- Current participation in a therapeutic clinical trial.
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 |
|---|---|---|
| patient engagement platform1. Allows patients to receive the action plan as educational videos on demand. 2. Allows patients to report side effects and quality of life via questionnaires and receive immediate targeted education based on the predefined action plan. | Other | personalized engagement platform |
Primary outcome
Feasibility of PEP (percent of patients using videos/complete questionnaires)
Time frame: 3 years
To assess the feasibility of implementing a PEP in the outpatient gastrointestinal malignancies service, at Sheba Medical Center, for patients undergoing active chemotherapy treatment. This outcome will be measured as percent of patients using the videos and percent of patients that complete the questionnaires.
4 secondary outcomes
Secondary clinical outcomes 1 (mean number of referrals)
Time frame: 3 years
Secondary clinical outcomes 2 (level of chemotoxicity)
Time frame: 3 years
Secondary clinical outcomes 3 (Quality of Life)
Time frame: 3 years
Secondary clinical outcomes 4 (treatment intensity and continuity)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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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.
Ofer Margali, MD PhD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient engagement platform in people with Colon Cancer and Gastric Cancer, run by Sheba Medical Center at 1 site in Israel.
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 8 inclusion and 4 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: finished, 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of PEP (percent of patients using videos/complete questionnaires) (time frame: 3 years). 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.