Colorectal CancerGet ReadyNCT04153721
Impact Study of a Digital Solution for Patient Engagement
A study testing Name Digital Solution in people with Colorectal Cancer, run by IHU Strasbourg at 1 site in France.
Trial summary
The Institute of Image-Guided Surgery (IHU) of Strasbourg develops new minimally invasive therapies, the benefit of which is maximized by an integrated approach to the care pathway (pre, per and postoperative). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Name Digital Solution
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2020to 10 Mar 2023
- 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
- Major patient candidate for a scheduled colorectal surgery and whose admission is expected within 8 days minimum
- Patient with an email address and an internet connection
- Patient able to receive and understand information about the study and give written informed consent
Who cannot join
- Patient under the age of 18 years old.
- Pregnant or lactating patient
- Patient in exclusion period (determined by a previous or a current study)
- Patient under guardianship, trusteeship or the protection of justice
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Digestive et Endocrinienne, NHC
Strasbourg, 67000
About this study
Official title: Evaluation of a Digital Perioperative Support Solution for Colorectal Surgery: Compliance and Impact on Patients
The Institute of Image-Guided Surgery (IHU) of Strasbourg develops new minimally invasive therapies, the benefit of which is maximized by an integrated approach to the care pathway (pre, per and postoperative).
Encouraging patient engagement in the process responds to its growing demand for information and consideration, enhances its care experience and clinical outcomes.
Read more
Medtronic has designed an digital solution for patient engagement (current name: "Get Ready") for scheduled colorectal surgery. The IHU is a pilot experiment site for this solution. This research protocol, of which the IHU is the promoter, aims at evaluating the use and the impact of this solution made available to the patients of the Hepato-Digestive Pole (PHD) of the New Civil Hospital.
The solution deployed at the Strasbourg IHU aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices.
The solution is not a medical device. It is limited to advice, monitoring and restitution of data declared by the patient; it is not intended to prevent, diagnose or treat the pathology; it is independent of any other medical device.
This study aims to assess the pre-operative impact of the solution, in terms of patients' adherence to the pre-operative program and correlations with their physical and psychological condition until their admission to surgery. The secondary purpose of the study is to precise the acceptability of the solution.
Read the detailed description
The Institute of Image-Guided Surgery (IHU) of Strasbourg develops new minimally invasive therapies, the benefit of which is maximized by an integrated approach to the care pathway (pre, per and postoperative).
Encouraging patient engagement in the process responds to its growing demand for information and consideration, enhances its care experience and clinical outcomes. Patient engagement promotes accelerated rehabilitation and reduces complications and readmissions, which is also beneficial in terms of public health.
Medtronic has designed a digital solution for patient engagement (current name: "Get Ready") for scheduled colorectal surgery, for which the IHU is a pilot experiment site. This research protocol aims at evaluating the use and the impact of this solution made available to the patients of the Hepato-Digestive Pole (PHD) of the New Civil Hospital.
Multiple professionals dispense instructions and information to patients. The active accompaniment of the patient in his rehabilitation process is carried out mainly in the postoperative phase, during the hospital stay.
The solution deployed at the Strasbourg IHU aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices.
The solution offers a pre-operative program of information (pathology, treatment modalities, protocols to be followed) and training (stress management, psychological support, optional: nutritional preparation, physical exercise, reduction of alcohol and tobacco consumption). In the post-operative phase, patients must daily assess their state of health (temperature, weight, wound, nausea / vomiting, urine / stool) and well-being (physical, moral, sleep, pain), from day 1 to day 7 after discharge, to facilitate the detection of complications by the medical team.
The program is personalized by patient, according to its management (type of surgery, duration of the program) and its state of health (choice of options adapted by the doctor).
The solution has three components to interact with the patient:
- A website, offering information and activities adapted to the patient's journey. A second site allows the licensed care team to track adherence and patient-reported data.
- SMS (Short Message Service) notifications, for the patient who can and wants to receive SMS. It encourages the monitoring of the program (reminders).
- An on-site IHU support team, accessible by phone and email. She ensures the smooth running of the program, supervises the information declared by the patient and relays his questions to the relevant interlocutors (care team, technical experts).
The solution is not a medical device. It is limited to advice, monitoring and restitution of data declared by the patient; it is not intended to prevent, diagnose or treat the pathology; it is independent of any other medical device.
The solution processes personal information. Particular vigilance is therefore given to security: compliance with legislation, state-of-the-art techniques used, respect for privacy from the upstream and by default, transparency and control, security measures (eg data encryption, double authentication, lack of interfaces to other information systems, accredited health host).
According to the literature, the preparation of the patient for surgery makes it possible to shorten the length of stay, the perioperative morbidity, the delay to come back to normal activity. This medical impact results in a reduction in post-operative costs (reduction of the length of stay, complications and readmissions), for the health facility and the payer. Improvement and systematization of the solution should help generate these savings.
The impact of the solution on the workload and the organization of the care team is to be specified.
This study aims to assess the pre-operative impact of the solution, in terms of patients' adherence to the pre-operative program and correlations with their physical and psychological condition until their admission to surgery.
- Conditions
- Colorectal Cancer
- Being tested
- Name Digital Solution
- Keywords
- enhanced recovery, rehabilitation, prehabilitation, patient engagement, digital health, e-health, colorectal surgery, preparation, follow-up, patient empowerment
- Medical subject headings
- Colorectal Neoplasms, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Name Digital SolutionBehavioural
The digital solution offers a pre-operative program of information (pathology, treatment modalities, protocols to be followed) and training (stress management, psychological support, optional: nutritional preparation, physical exercise, reduction of alcohol and tobacco consumption).
In the post-operative phase, patients must daily assess their state of health (temperature, weight, wound, nausea / vomiting, urine / stool) and well-being (physical, moral, sleep, pain), from day 1 to day 7 after discharge, to facilitate the detection of complications by the medical team
| Study group | Role | What they receive |
|---|---|---|
| Digital Solution | Experimental | The proposed digital solution aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices Receives: Behavioral: Name Digital Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation, during the preoperative phase, of patients' compliance to the program, assessed by a completeness rate.
Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The first part of the primary endpoint of the study is the average rate of completeness of the preoperative program: percentage based on the status (done / not done) of pre-operative tasks specific to each patient
Measured: From the inclusion to the surgery
Change, during the preoperative phase, of the physical condition of the patients, assessed by 6MTW scoring.
Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The second part of the primary endpoint of the study is the correlation between the patient compliance and the evolution of the physical condition :
comparison between two walk tests, one done at the inclusion, the other when admitted for surgery. The result of the walk test is the distance travelled in meters during the test (6 minutes) by the patient.
Measured: At the start of the program (6 weeks before the surgery) and at the admission before the surgery
Change, during the preoperative phase, of the psychological condition of the patients, assessed by the PHQ8 questionnaire scoring.
Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The third part of the primary endpoint of the study is the correlation between the patient compliance and the evolution of the psychological condition assessed by the questionnaire PHQ8 (Brief "Patient Health Questionnaire" depression scale): questions the existence and intensity of depressive symptoms (score from 0 to 24 in case of severe depression).
Measured: At the start of the program (6 weeks before the surgery) and at the admission before the surgery
Change, during the preoperative phase, of the psychological condition of the patients, assessed by GAD7 questionnaire scoring.
Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The fourth part of the primary endpoint of the study is the correlation between the patient compliance and the evolution of the psychological condition evaluated by the questionnaire GAD7 ("Generalized Anxiety Disorder 7"-item): indicates the severity of the anxiety (score from 0 to 21 in case of generalized anxiety disorder)
Measured: At the start of the program (6 weeks before the surgery) and at the admission before the surgery
Secondary outcomes (10)
Evaluation of patients' compliance with their post-operative program
Completeness rate of the postoperative program. This rate is calculated according to the status (done or not done) of the tasks to be performed by the patient after the surgical procedure: daily evaluations the first week and the 14th day after discharge from hospital. Task status is plotted in the digital solution.
Measured: Everyday for 7 days after the discharge from hospital and on the 14th day after the discharge from hospital
Persistence of program compliance between pre- and post-operative phases
Persistence of the program compliance, defined as the difference between the pre and the postoperative completeness rate of the program
Measured: From the inclusion to the end of participation
Patient satisfaction regarding the program
The satisfaction is assessed on all patients by three questions (useful, adapted, promotable program). The scores obtained on these three questions will be measured pre-operatively, post-operatively and averaged over the whole program. These scores are calculated automatically by the solution.
Measured: 2 days before the surgery and on the 14th day after the discharge from hospital
Evaluation, during the preoperative phase, of patient use of the program without compliance, assessed by a rate of undone activities
For patients with a preoperative physical activity and/or nutritional program prescribed, number of declared as undone activities compared to the total number of prescribed activities
Measured: from 6 weeks before the surgery up to the surgery
Patient interactions with the help desk of the solution
Rate of patient interactions with the help desk of the solution, defined as the mean number of phone call and emails per patient
Measured: from the inclusion to the end of participation
Evaluation of the solution and its use by the patient
Qualitative interview with the patient, carried out during his follow-up consultation J30
Measured: Visit Day 30
Evaluation of the solution and its use by health care providers
Qualitative interview with health care providers (physicians, interns), carried out at the end of the study
Measured: End of study
Evaluation of the postoperative complication rate
Number of postoperative complications identified 30 days after the surgery
Measured: Visit Day 30
Evaluation of duration of hospital stays
Quantification of the hospital stay duration, defined as defined by the difference between the date of discharge from hospital and the date of admission
Measured: from the day before the admission until the end of hospitalisation
Evaluation of the number of postoperative critical values
The number of post-operative critical values detected following daily assessments in the week following discharge from hospital, in accordance with the thresholds defined by the care team
Measured: 7 days after the discharge of the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start11 Mar 2020
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Mutter, MD, PhD, Principal investigator, Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153721
- Sponsor's protocol ID
- 19-007
- Acronym
- Get Ready
- Status last verified
- Feb 2024
- First submitted
- 21 Oct 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13.
PubMed 24439570Wind J, Polle SW, Fung Kon Jin PH, Dejong CH, von Meyenfeldt MF, Ubbink DT, Gouma DJ, Bemelman WA; Laparoscopy and/or Fast Track Multimodal Management Versus Standard Care (LAFA) Study Group; Enhanced Recovery after Surgery (ERAS) Group. Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg. 2006 Jul;93(7):800-9. doi: 10.1002/bjs.5384.
PubMed 16775831Wang L, Lee M, Zhang Z, Moodie J, Cheng D, Martin J. Does preoperative rehabilitation for patients planning to undergo joint replacement surgery improve outcomes? A systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2016 Feb 2;6(2):e009857. doi: 10.1136/bmjopen-2015-009857.
PubMed 26839013Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.
PubMed 23052535van der Meij E, Anema JR, Leclercq WKG, Bongers MY, Consten ECJ, Schraffordt Koops SE, van de Ven PM, Terwee CB, van Dongen JM, Schaafsma FG, Meijerink WJHJ, Bonjer HJ, Huirne JAF. Personalised perioperative care by e-health after intermediate-grade abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial. Lancet. 2018 Jul 7;392(10141):51-59. doi: 10.1016/S0140-6736(18)31113-9. Epub 2018 Jun 21.
PubMed 29937195Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.
PubMed 21878237Snow R, Granata J, Ruhil AV, Vogel K, McShane M, Wasielewski R. Associations between preoperative physical therapy and post-acute care utilization patterns and cost in total joint replacement. J Bone Joint Surg Am. 2014 Oct 1;96(19):e165. doi: 10.2106/JBJS.M.01285.
PubMed 25274793van Rooijen S, Carli F, Dalton S, Thomas G, Bojesen R, Le Guen M, Barizien N, Awasthi R, Minnella E, Beijer S, Martinez-Palli G, van Lieshout R, Gogenur I, Feo C, Johansen C, Scheede-Bergdahl C, Roumen R, Schep G, Slooter G. Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: the first international randomized controlled trial for multimodal prehabilitation. BMC Cancer. 2019 Jan 22;19(1):98. doi: 10.1186/s12885-018-5232-6.
PubMed 30670009Lin LY, Wang RH. Abdominal surgery, pain and anxiety: preoperative nursing intervention. J Adv Nurs. 2005 Aug;51(3):252-60. doi: 10.1111/j.1365-2648.2005.03502.x.
PubMed 16033593Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14.
PubMed 21236454Pecorelli N, Fiore JF Jr, Gillis C, Awasthi R, Mappin-Kasirer B, Niculiseanu P, Fried GM, Carli F, Feldman LS. The six-minute walk test as a measure of postoperative recovery after colorectal resection: further examination of its measurement properties. Surg Endosc. 2016 Jun;30(6):2199-206. doi: 10.1007/s00464-015-4478-1. Epub 2015 Aug 27.
PubMed 26310528Hijazi Y, Gondal U, Aziz O. A systematic review of prehabilitation programs in abdominal cancer surgery. Int J Surg. 2017 Mar;39:156-162. doi: 10.1016/j.ijsu.2017.01.111. Epub 2017 Feb 2.
PubMed 28161527Inoue T, Ito S, Kanda M, Niwa Y, Nagaya M, Nishida Y, Hasegawa Y, Koike M, Kodera Y. Preoperative six-minute walk distance as a predictor of postoperative complication in patients with esophageal cancer. Dis Esophagus. 2020 Mar 5;33(2):doz050. doi: 10.1093/dote/doz050.
PubMed 31111872Chen YC, Chen KC, Lu LH, Wu YL, Lai TJ, Wang CH. Validating the 6-minute walk test as an indicator of recovery in patients undergoing cardiac surgery: A prospective cohort study. Medicine (Baltimore). 2018 Oct;97(42):e12925. doi: 10.1097/MD.0000000000012925.
PubMed 30335028Marek W, Marek E, Vogel P, Muckenhoff K, Kotschy-Lang N. [A new procedure for the estimation of physical fitness of patients during clinical rehabilitation using the 6-minute-walk-test]. Pneumologie. 2008 Nov;62(11):643-54. doi: 10.1055/s-2008-1038204. Epub 2008 Aug 18. German.
PubMed 18711694
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Digital Perioperative Support Solution for Colorectal Surgery: Compliance and Impact on Patients
- ClinicalTrials.gov ID
- NCT04153721
- Acronym / sponsor ID
- Get Ready / 19-007
- Conditions
- Colorectal Cancer
- Keywords
- enhanced recovery, rehabilitation, prehabilitation, patient engagement, digital health, e-health, colorectal surgery, preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 6 Nov 2019 (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.
The Institute of Image-Guided Surgery (IHU) of Strasbourg develops new minimally invasive therapies, the benefit of which is maximized by an integrated approach to the care pathway (pre, per and postoperative).
Encouraging patient engagement in the process responds to its growing demand for information and consideration, enhances its care experience and clinical outcomes.
Medtronic has designed an digital solution for patient engagement (current name: "Get Ready") for scheduled colorectal surgery. The IHU is a pilot experiment site for this solution. This research protocol, of which the IHU is the promoter, aims at evaluating the use and the impact of this solution made available to the patients of the Hepato-Digestive Pole (PHD) of the New Civil Hospital.
The solution deployed at the Strasbourg IHU aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices.
The solution is not a medical device. It is limited to advice, monitoring and restitution of data declared by the patient; it is not intended to prevent, diagnose or treat the pathology; it is independent of any other medical device.
This study aims to assess the pre-operative impact of the solution, in terms of patients' adherence to the pre-operative program and correlations with their physical and psychological condition until their admission to surgery. The secondary purpose of the study is to precise the acceptability of the solution.
Detailed description
The Institute of Image-Guided Surgery (IHU) of Strasbourg develops new minimally invasive therapies, the benefit of which is maximized by an integrated approach to the care pathway (pre, per and postoperative).
Encouraging patient engagement in the process responds to its growing demand for information and consideration, enhances its care experience and clinical outcomes. Patient engagement promotes accelerated rehabilitation and reduces complications and readmissions, which is also beneficial in terms of public health.
Medtronic has designed a digital solution for patient engagement (current name: "Get Ready") for scheduled colorectal surgery, for which the IHU is a pilot experiment site. This research protocol aims at evaluating the use and the impact of this solution made available to the patients of the Hepato-Digestive Pole (PHD) of the New Civil Hospital.
Multiple professionals dispense instructions and information to patients. The active accompaniment of the patient in his rehabilitation process is carried out mainly in the postoperative phase, during the hospital stay.
The solution deployed at the Strasbourg IHU aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices.
The solution offers a pre-operative program of information (pathology, treatment modalities, protocols to be followed) and training (stress management, psychological support, optional: nutritional preparation, physical exercise, reduction of alcohol and tobacco consumption). In the post-operative phase, patients must daily assess their state of health (temperature, weight, wound, nausea / vomiting, urine / stool) and well-being (physical, moral, sleep, pain), from day 1 to day 7 after discharge, to facilitate the detection of complications by the medical team.
The program is personalized by patient, according to its management (type of surgery, duration of the program) and its state of health (choice of options adapted by the doctor).
The solution has three components to interact with the patient:
- A website, offering information and activities adapted to the patient's journey. A second site allows the licensed care team to track adherence and patient-reported data.
- SMS (Short Message Service) notifications, for the patient who can and wants to receive SMS. It encourages the monitoring of the program (reminders).
- An on-site IHU support team, accessible by phone and email. She ensures the smooth running of the program, supervises the information declared by the patient and relays his questions to the relevant interlocutors (care team, technical experts).
The solution is not a medical device. It is limited to advice, monitoring and restitution of data declared by the patient; it is not intended to prevent, diagnose or treat the pathology; it is independent of any other medical device.
The solution processes personal information. Particular vigilance is therefore given to security: compliance with legislation, state-of-the-art techniques used, respect for privacy from the upstream and by default, transparency and control, security measures (eg data encryption, double authentication, lack of interfaces to other information systems, accredited health host).
According to the literature, the preparation of the patient for surgery makes it possible to shorten the length of stay, the perioperative morbidity, the delay to come back to normal activity. This medical impact results in a reduction in post-operative costs (reduction of the length of stay, complications and readmissions), for the health facility and the payer. Improvement and systematization of the solution should help generate these savings.
The impact of the solution on the workload and the organization of the care team is to be specified.
This study aims to assess the pre-operative impact of the solution, in terms of patients' adherence to the pre-operative program and correlations with their physical and psychological condition until their admission to surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Solution | Experimental | Behavioral: Name Digital SolutionThe proposed digital solution aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major patient candidate for a scheduled colorectal surgery and whose admission is expected within 8 days minimum
- Patient with an email address and an internet connection
- Patient able to receive and understand information about the study and give written informed consent
Key exclusion criteria (4 listed)
- Patient under the age of 18 years old.
- Pregnant or lactating patient
- Patient in exclusion period (determined by a previous or a current study)
- Patient under guardianship, trusteeship or the protection of justice
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 |
|---|---|---|
| Name Digital SolutionThe digital solution offers a pre-operative program of information (pathology, treatment modalities, protocols to be followed) and training (stress management, psychological support, optional: nutritional preparation, physical exercise, reduction of alcohol and tobacco consumption). In the post-operative phase, patients must daily assess their state of health (temperature, weight, wound, nausea / vomiting, urine / stool) and well-being (physical, moral, sleep, pain), from day 1 to day 7 after discharge, to facilitate the detection of complications by the medical team | Behavioural | Digital Solution |
Primary outcome
Evaluation, during the preoperative phase, of patients' compliance to the program, assessed by a completeness rate.
Time frame: From the inclusion to the surgery
Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The first part of the primary endpoint of the study is the average rate of completeness of the preoperative program: percentage based on the status (done / not done) of pre-operative tasks specific to each patient
Change, during the preoperative phase, of the physical condition of the patients, assessed by 6MTW scoring.
Time frame: At the start of the program (6 weeks before the surgery) and at the admission before the surgery
Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The second part of the primary endpoint of the study is the correlation between the patient compliance and the evolution of the physical condition : comparison between two walk tests, one done at the inclusion, the other when admitted for surgery. The result of the walk test is the distance travelled in meters during the test (6 minutes) by the patient.
Change, during the preoperative phase, of the psychological condition of the patients, assessed by the PHQ8 questionnaire scoring.
Time frame: At the start of the program (6 weeks before the surgery) and at the admission before the surgery
Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The third part of the primary endpoint of the study is the correlation between the patient compliance and the evolution of the psychological condition assessed by the questionnaire PHQ8 (Brief "Patient Health Questionnaire" depression scale): questions the existence and intensity of depressive symptoms (score from 0 to 24 in case of severe depression).
Change, during the preoperative phase, of the psychological condition of the patients, assessed by GAD7 questionnaire scoring.
Time frame: At the start of the program (6 weeks before the surgery) and at the admission before the surgery
Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The fourth part of the primary endpoint of the study is the correlation between the patient compliance and the evolution of the psychological condition evaluated by the questionnaire GAD7 ("Generalized Anxiety Disorder 7"-item): indicates the severity of the anxiety (score from 0 to 21 in case of generalized anxiety disorder)
10 secondary outcomes
Evaluation of patients' compliance with their post-operative program
Time frame: Everyday for 7 days after the discharge from hospital and on the 14th day after the discharge from hospital
Persistence of program compliance between pre- and post-operative phases
Time frame: From the inclusion to the end of participation
Patient satisfaction regarding the program
Time frame: 2 days before the surgery and on the 14th day after the discharge from hospital
Evaluation, during the preoperative phase, of patient use of the program without compliance, assessed by a rate of undone activities
Time frame: from 6 weeks before the surgery up to the surgery
Patient interactions with the help desk of the solution
Time frame: from the inclusion to the end of participation
Evaluation of the solution and its use by the patient
Time frame: Visit Day 30
Evaluation of the solution and its use by health care providers
Time frame: End of study
Evaluation of the postoperative complication rate
Time frame: Visit Day 30
Evaluation of duration of hospital stays
Time frame: from the day before the admission until the end of hospitalisation
Evaluation of the number of postoperative critical values
Time frame: 7 days after the discharge of the hospital
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 20 Feb 2024.
- Background: PubMed 24439570Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13.
- Background: PubMed 16775831Wind J, Polle SW, Fung Kon Jin PH, Dejong CH, von Meyenfeldt MF, Ubbink DT, Gouma DJ, Bemelman WA; Laparoscopy and/or Fast Track Multimodal Management Versus Standard Care (LAFA) Study Group; Enhanced Recovery after Surgery (ERAS) Group. Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg. 2006 Jul;93(7):800-9. doi: 10.1002/bjs.5384.
- Background: PubMed 26839013Wang L, Lee M, Zhang Z, Moodie J, Cheng D, Martin J. Does preoperative rehabilitation for patients planning to undergo joint replacement surgery improve outcomes? A systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2016 Feb 2;6(2):e009857. doi: 10.1136/bmjopen-2015-009857.
- Background: PubMed 23052535Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.
- Background: PubMed 29937195van der Meij E, Anema JR, Leclercq WKG, Bongers MY, Consten ECJ, Schraffordt Koops SE, van de Ven PM, Terwee CB, van Dongen JM, Schaafsma FG, Meijerink WJHJ, Bonjer HJ, Huirne JAF. Personalised perioperative care by e-health after intermediate-grade abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial. Lancet. 2018 Jul 7;392(10141):51-59. doi: 10.1016/S0140-6736(18)31113-9. Epub 2018 Jun 21.
- Background: PubMed 21878237Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.
- Background: PubMed 25274793Snow R, Granata J, Ruhil AV, Vogel K, McShane M, Wasielewski R. Associations between preoperative physical therapy and post-acute care utilization patterns and cost in total joint replacement. J Bone Joint Surg Am. 2014 Oct 1;96(19):e165. doi: 10.2106/JBJS.M.01285.
- Background: PubMed 30670009van Rooijen S, Carli F, Dalton S, Thomas G, Bojesen R, Le Guen M, Barizien N, Awasthi R, Minnella E, Beijer S, Martinez-Palli G, van Lieshout R, Gogenur I, Feo C, Johansen C, Scheede-Bergdahl C, Roumen R, Schep G, Slooter G. Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: the first international randomized controlled trial for multimodal prehabilitation. BMC Cancer. 2019 Jan 22;19(1):98. doi: 10.1186/s12885-018-5232-6.
- Background: PubMed 16033593Lin LY, Wang RH. Abdominal surgery, pain and anxiety: preoperative nursing intervention. J Adv Nurs. 2005 Aug;51(3):252-60. doi: 10.1111/j.1365-2648.2005.03502.x.
- Background: PubMed 21236454Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14.
- Background: PubMed 26310528Pecorelli N, Fiore JF Jr, Gillis C, Awasthi R, Mappin-Kasirer B, Niculiseanu P, Fried GM, Carli F, Feldman LS. The six-minute walk test as a measure of postoperative recovery after colorectal resection: further examination of its measurement properties. Surg Endosc. 2016 Jun;30(6):2199-206. doi: 10.1007/s00464-015-4478-1. Epub 2015 Aug 27.
- Background: PubMed 28161527Hijazi Y, Gondal U, Aziz O. A systematic review of prehabilitation programs in abdominal cancer surgery. Int J Surg. 2017 Mar;39:156-162. doi: 10.1016/j.ijsu.2017.01.111. Epub 2017 Feb 2.
- French National Authority for Health, Recommendation of good practice: Adult characterized depressive episode : primary care. October 2017Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
Not yet recruitingPhase 2
Phase II Clinical Study of RC148 (ABBV-1480) in Combination With Telisotuzumab Adizutecan (With or Without Chemotherapy) for Unresectable Colorectal Cancer
Patients With Unresectable Colorectal Cancer Requiring First-Line or Second-Line Therapy
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
Active, not recruitingPhase 3
Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma
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.
Didier Mutter, MD, PhD principal investigator
Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Name Digital Solution in people with Colorectal Cancer, run by IHU Strasbourg 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 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 20 Feb 2024. 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?
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?
Evaluation, during the preoperative phase, of patients' compliance to the program, assessed by a completeness rate. (time frame: From the inclusion to the surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04153721, which also lists 17 linked publications.
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 20 Feb 2024.