Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Behaviors and Mental Disorders

Emergencies

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Quality of Life

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

All the patients undergo multidimensional tele monitoring for 7 weeks using an upgraded version of the Picado internet platform

The system will monitor the circadian rhythms, physical activity, sleep, symptoms and body weight of patients with advanced pancreatic cancer during one week before (baseline) and six weeks after the 1st course of standard mFOLFIRINOX. The reach of preset thresholds for several parameters that are automatically computed will trigger alerts toward approved health professionals, and their responses will be traced.

Picado system internet platform and connected objects

JEAN FRANÇOIS OUDET

Marie Barba

Jean Francois OUDET

Mohamed BOUCHAHDA, Dr

Francis LEVI, Pr

Pancreatic cancer is a rapidly developing cancer with a poor prognosis. The mFOLFIRINOX protocol has become the standard medical treatment for this pathology. However, mFOLFIRINOX is the cause of severe toxicities including leukoneutropenia, thrombocytopenia, diarrhea, nausea-vomiting, anorexia, asthenia, weight loss and peripheral sensory neuropathy. Therefore, its indication is limited to patients in good general condition. In practice, it is often interrupted upon the occurrence of hematological and/or clinical grade 3-4 toxicities, Remote patient tele-monitoring of symptoms (Patient Reported Outcomes), body weight, circadian rhythms, sleep and activity would allow the identification of early warning signals reflecting deterioration or improvement in the health of these fragile patients, and trigger proactive interventions, while they are outside the hospital. Thus, the MultiDom study proposes a comprehensive tele-monitoring and telecare strategy that would complement standard of care over a 7-weeks period to 42 consenting patients. The patients receive neoadjuvant or first line chemotherapy with mFOLFIRINOX for advanced or metastatic pancreatic cancer at one of four centres in Ile-de-France region (France).

MultiDom stands up among the very first prospective patient-entered and multidimensional, multiactor and multicenter study, that assesses the qualitative and quantitative impact of mFOLFIRINOX on the daily life of patients with pancreatic cancer in real time. Main endpoint is the rate of patients undergoing toxicity-related emergency hospitalisations, and the objective is to reduce it to \<10%. Telemonitored data-based proactive interventions will expectedly prevent worsening of patients 'health, and maintain their chances of disease control on effective mFOLFIRINOX chemotherapy.

Participating patients have usual follow up and treatments for their disease, but also: wear a chest sensor that measures and teletransmits accelerometry, surface temperature and 3D-orientation every min, weigh themselves daily on a BLE-balance, with immediate weight tele transmission, and fill out electronic PRO questionnaires daily using a telecommunicating tablet.

All data are tele transmitted to an approved health data hub, and automatically analysed for physical activity, sleep, circadian rhythms, symptoms scores trends in real time. Visualization screens and alerts are generated according to preset thresholds, and medical team responses are traced.

Currently recruiting centres:

1. Clinique du Mousseau, Evry, France
2. Hospital Paul Brousse (Assistance Publique-Hôpitaux de Paris), Villejuif, France
3. Clinique St-Jean L'Ermitage, Melun, France
4. Private Hospital of Antony, Antony, France

Multidom Remote Monitoring of Patient With Advanced Pancreatic Cancer Treated With Florinox Using the PiCaDo Plateform

Multidom Remote Monitoring of Patient With Advanced Pancreatic Cancer Treated With Florinox Using the PiCaDo Domomedecine Plateform

Individual participant data that underlie the results reported in the original trial report manuscripts will be shared after deidentification. Supportive information will consist in the study protocol.

The main objective is to assess the toxicities occurring during the 6 weeks following the start of the 1st cycle of FOLFIRINOX in conventional administration in patients benefiting from the PiCADo telemonitoring system.

Secondary objectives include rates and grades of toxicity and early tumor responses, as well as PiCADo platform performances and users perceptions.

Faculty of Medicine Paris Saclay University

Altran

Assistance Publique - Hôpitaux de Paris

Ramsay Générale de Santé

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Familial Colorectal Cancer

Herbal and Botanical

Cola

Participants in this arm receive a personalized telephone-risk assessment intervention provided by a trained cancer risk counselor.

Participants in this group receive a mailed pamphlet containing information about familial colorectal cancer risk and screening.

Personalized telephone-delivered cancer risk assessment.

TeleCARE

Mailed pamphlet about familial colorectal cancer risk and screening.

Pamphlet intervention

Anita Y Kinney, Ph.D., R.N.

The Family Colorectal Cancer Awareness and Risk Education Project (Family CARE Project) is designed to determine whether a personalized telephone plus mailed print cancer risk assessment and behavior change counseling intervention is more effective than a targeted mailed print intervention in promoting risk appropriate screening in individuals with a family history of the disease. The project targets people residing in both rural and urban areas, allowing an examination of differential intervention effects with regard to place of residence.

The rate of adherence to regular colonoscopy screening (CS) among members of families at increased risk for colorectal cancer (CRC) is far below recommended levels. Persons who live in rural areas of the United States exhibit lower CRC screening rates than their urban counterparts. Although the detection of familial predisposition to cancer begins with an accurate family medical history, data indicate that many patients do not receive adequate familial cancer risk assessment from their primary care providers. This suggests that familial risk is largely unrecognized which may lead to inadequate risk stratification, lack of risk notification, appropriate risk counseling, suboptimal cancer screening and preventable deaths. Because of geographic and system-level barriers, special efforts are needed to improve access to personalized risk communication and adherence to CRC screening to rural and other geographically underserved populations at increased risk for CRC. In the proposed study, we will evaluate a novel telephone-based, theory-guided personalized risk communication intervention that combines a familial CRC risk assessment and behavioral counseling with tailored messages. The key hypothesis guiding this study is that a multifaceted personalized risk communication intervention will improve CS at a significantly higher rate than a mailed targeted print intervention.

Our integrative study model specifies important theoretical mechanisms that can contribute to increased use of CS among persons at increased risk. We will enroll 438 adult men and women between the ages of 30-74 who are considered at increased risk of familial CRC into this 2-group randomized trial. The primary aim of this study is to compare colonoscopy use among participants in the two groups. Secondary aims are to compare the two groups with regard to cognitive and emotional outcomes and explore the underlying mechanisms through which the interventions have an impact on colonoscopy behavior. Sociodemographic, clinical, behavioral and psychosocial measures will be collected from participants at baseline, and 1 month, 9 months, and 15 months following the intervention. Self-reported colonoscopy is verified with medical records.

The study's findings will have both theoretical, as well as practical significance. Our findings will help to influence the selection and dissemination of effective outreach approaches to improve CRC screening in populations at increased risk for the disease. These results have broad applicability to understanding responses to personalized risk communication interventions for other diseases as well. Findings will also broaden our understanding of the underlying theoretical mechanisms of how remote cancer risk communications lead to improvements in cancer screening among geographically underserved populations if such intervention effects are observed.

In addition to studying the intervention effects in rural areas, we will enroll participants in urban areas. These enhancements to our population-based randomized behavioral trial will provide us with an unprecedented opportunity to assess reach and determine if there are differential intervention effects (i.e., efficacy) with regard to place of residence (rurality vs. urbanicity.)

Family Colorectal Cancer Awareness and Risk Education Project (Family CARE Project)

Impact of Remote Familial Colorectal Cancer Assessment and Counseling

The primary outcome is colonoscopy. Medical record verification of self-reported colonoscopy is performed.

Fecal occult blood test(FOBT) following the intervention. Medical confirmation of self-reported FOBT/FIT is performed.

The Perceived Personal Control Scale is an integrative outcome that encompasses the broad spectrum of health risk communication and informed decision-making. This validated scale is a 9-item measure representing three dimensions of control participants believe they have regarding family history of colorectal cancer (CRC): cognitive-interpretive, decisional, and behavioral. A 5-point Likert-style response format is used ranging from very little control to very high control. A total scale score is calculated by summing the items.

A 4-item scale with established construct and predictive validity with regard to cancer screening will assess participants' subjective perceived risk for developing colorectal cancer. Responses are measured on a five-point Likert scale ranging from very small to very large.

Generalized psychological distress will be operationalized as state anxiety and we will use the State Subscale of the State Trait Anxiety Inventory. We will also measure cancer-specific distress with the Impact of Event Scale. The stressor in this study is having a family history of colorectal cancer.

The Colorectal Cancer Knowledge Survey is a validated 12-item scale that assesses colorectal cancer screening knowledge, colorectal cancer risk factors (including family history) and CRC symptoms. The questionnaire consists of true/false with a possible range of scores of 0-12. FOBT items will be substituted with colonoscopy.

Participants are asked to evaluate whether or not they feel confident in their decision to receive or not receive CRC screening. Assessment following the intervention will determine whether the decisional conflict has been resolved and whether or not that resolution results in colonoscopy uptake.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Multidom Remote Monitoring of Patient With Advanced Pancreatic Cancer Treated With Florinox Using the PiCaDo Plateform	NCT04263948	Pancreas Cancer	Picado system i...	18 Years - 85 Years	Ramsay Générale de Santé
Family Colorectal Cancer Awareness and Risk Education Project (Family CARE Project)	NCT01274143	Colorectal Canc...	TeleCARE Pamphlet interv...	30 Years - 74 Years	University of Utah

Spots Global Cancer Trial Database for telecare

Every month we try and update this database with for telecare cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for telecare

Every month we try and update this database with for telecare cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for telecare cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.