Clinical trial NCT06148610: Evaluation of the Impact of the Use of NewSpringForMe on Transplanted Patients' Quality of Life and Support
Official title: Evaluation of the Impact of the Use of the Digital Solution NewSpringForMe on Transplanted Patients' Quality of Life and Support (Bone Marrow or Peripheral Stem Cells Allotransplantation)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematologic Diseases
Bone Marrow Transplantation
Hematopoietic Stem Cell Transplantation
Keywords: Digital solution
Companion
Quality of life
Support
Hematopoietic Stem Cell Transplantation
Post-transplant complications
Psychological, physical and nutritional balance maintenance
Bone marrow Transplantation
Lead sponsor: Fonds de Dotation HTC Project
Sponsor class: OTHER
Collaborators: name: Saint-Louis Hospital, Paris, France
name: Nutricia Nutrition Clinique
name: Clinicprosport
name: ELLYE
name: Association Aïda
name: Gilead Sciences
name: Pfizer
name: Groupe Apicil
name: Association Laurette Fugain
name: Fondation du LEEM
name: Fondation AFNIC
name: Pierre Fabre Medicament
name: Novartis Pharmaceuticals
name: University Hospital, Clermont-Ferrand
name: LAPSCO, Université Clermont-Auvergne
First posted: 2023-11-28
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with haemopathies, malignant or not, justifying a first indication of bone marrow or peripheral stem cells allo transplantation

Brief summary: Bone marrow transplantation is both a great treatment for patients with hematological diseases. It is also one of the only hopes of staying alive by "starting from scratch". It is a trying life experience, at all its stages. To support these patients and increase their success in healing and returning to a "normal life", quality of life is an ally of choice for the success of care.

NewSpringForMe is an innovative tool designed for the benefit of transplant patients, through the deployment of unprecedented interdisciplinary support benefiting from the best digital technologies. This digital solution is aimed at all patients, adults and pediatrics, before, during and after bone marrow transplantation, in a long-term approach. NewSpringForMe results from the multidisciplinary collaboration of medical and paramedical experts in the field of hematology and transplantation, as well as in the field of psychology.

With NewSpringForMe, each transplant patient has a personalized and scalable space accessible via a web platform, constantly offering, according to their needs and at their own pace, a range of recommendations, tools and exercises in psychology, nutrition / dietetics and physical activity, the three pillars of overall well-being. Perfectly integrated into the care pathway and the transplant protocol, from the announcement of the treatment to the long-term follow-up, several years after the intervention, NewSpringForMe complements the medical treatments provided by the medical profession: the communication of the assessments from the platform as well as patient data for caregivers allows adaptation of therapies and optimization of medical care. Thanks to the consideration of individual parameters and their evolution, and thanks to specific algorithms, each tool is adapted to the course of care and to the life of each patient, as well as to their personal health situation throughout their transplant journey.

In order to demonstrate the benefits of using NewSpringForMe, the project plans to evaluate the platform and its impact on the quality of life in patients with hematological diseases. This evaluation will be done by the patients themselves and by the nursing staff. The evaluation will be carried out using a monocentric approach on a pilot cohort. The objective is to demonstrate that integrative health ensuring simultaneous care of body and mind increases the chances of success of the transplant while limiting post-transplant complications.

Detailed description: Each year in France, nearly 2,000 patients, adults and children of all ages, are treated by bone marrow transplantation, the last therapeutic resort to treat and cure serious blood diseases, malignant or not. If this intervention saves more and more lives, it can lead to early or late complications in 50% of patients (graft versus host disease or GvHD in English for Graft versus Host Disease, cardiac and/or metabolic complications, etc.), very disabling on a daily basis and fatal in 25% of cases. The chances of success of the bone marrow transplant are directly correlated to the non-occurrence of these complications.

A mutual influence of psychological health and physical health on the chances of success of the transplant has been highlighted for several years. Simultaneous support of the mind and body based on the 3 pillars - nutritional, psychological, physical - would ensure better preparation for the transplant process for faster recovery after it thanks to the limitation of the occurrence of complications.

However, to date there is no comprehensive support program covering both mental and physical health to help patients overcome the difficulties associated with the transplant and the return to social and professional life.

As part of their care pathway, patients can benefit from sectorized support but it remains incompletely developed, which can generate in patients a feeling of abandonment on the part of the medical team once the cancer treatment is complete.

It is in this context that the digital support solution for transplant patients, called NewSpringForMe, emerged. This project is on the initiative of Professor Régis Peffault de Latour, hematologist-transplanter at Saint-Louis Hospital in Paris. The latter relied on more than 15 years of experience in contact with transplant patients to highlight an unmet need in terms of support. This need is for therapeutic support that complements care, reinforcing it, and making each patient the main actor in his or her quality of life. To fill this gap, the interdisciplinary support tool, NewSpringForMe, combining psychology, nutrition and adapted physical activity, was developed. Thanks to a global management of these three dimensions throughout the transplant process (in the hospital but also in his daily life), NewSpringForMe aims at a better preparation and a more global management of the patient, condition of the best live towards his remission, by making him actor of his course of care.

NewSpringForMe is the first global support system developed in the field of bone marrow transplantation by an entity independent of healthcare structures, thus giving the tool greater accessibility to patients regardless of their prescribing hospital structure.

The innovation of the project is based on comprehensive support for bone marrow transplant patients in three dimensions: psychology, nutrition and physical activity, with the NewSpringForMe digital tool.

Designed around interconnected spaces, NewSpringForMe offers each patient, permanently, according to their needs and at their own pace, a range of tools and therapeutic exercises, complementary to the care provided by the medical and nursing profession, depending on their condition. progress in the transplant process.

* Nature: web platform providing more versatility, flexibility and maneuverability
* Transversality: integrative health for optimized preparation and comprehensive support
* Integration into the care pathway for long-term follow-up

A public health approach: NewSpringForMe's challenge is not only to improve support for patients, but also to keep them healthy throughout their bone marrow transplant experience, thus being part of a optimization of the French healthcare system for better social and professional reintegration.

A therapeutic tool, a place of exchange and sharing, a facilitator of social ties: success is based on the creation of a real dynamic of community of patients and on the increase of knowledge, in order to improve their care.

In order to measure the impact of the use of the NewSpringForMe digital solution, a monocentric pilot phase of evaluation is planned in a cohort of 150 to 200 patients allografted by bone marrow within the hematology transplant department of the Hospital Saint-Louis de Paris (AP-HP).

Recruitment: The NewSpringForMe support solution will be offered directly by the healthcare team (transplant doctor, transplant coordinator, etc.) to the patient identified to benefit from a transplant protocol and who meets the inclusion/exclusion criteria above. The medical team will submit the consent and information leaflet to the patient likely to be included. This protocol will be presented and carried out, if accepted by the patient, as part of routine care. Each patient included must provide written informed consent.

The impact study provides for a longitudinal follow-up of the patients included, based on their transplant journey. A follow-up of 1 year from the inclusion of the patient to the announcement of the transplant will make it possible to assess in a relevant way the impact of the use of the platform, to identify medium-term profiles in relation to the events post-transplant (relapse, complications, etc.). The duration of the project, including inclusion and follow-up of patients, analysis and exploitation of results, is estimated at 24 months.

To date, the IT development of the platform is 85% complete; improvements still need to be made to optimize the tool, the generation and the collection of data. In addition, the enrichment of the platform continues with the integration of visually optimized illustrations and cooking recipes adapted to diets in the journey of the transplant patient.

Once the impact has been demonstrated and assuming positive results, the digital solution can be deployed on a national scale, in all French allograft centers. This deployment will be carried out in collaboration with the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC) and the Biomedicine Agency. It will be aimed at all transplant patients for a serious cancerous blood disease - leukemia, lymphoma, etc. - or not, adults and pediatrics, representing a population of approximately 2,000 people per year (see annual activity reports of the Biomedicine Agency). Given the growing number of patients going for transplant, the development and implementation of this support program will have a strong impact in the medico-social field. These arguments also support the long-term viability of this support program.

Eligibility criteria: Inclusion criteria :

* at least 18 years old
* with a first indication for allograft bone marrow or Peripheric Stem Cells
* monitored by the adult hematology transplant department St-Louis Hospital
* having signed the consent
* affiliated to a social security scheme
* able to understand the objectives of the study and to use a digital tool

Exclusion criteria :

* aged under 18
* with an indication of second or third allograft
* not being affiliated to a social security scheme

Primary outcomes:
measure: Negative affects
timeFrame: 12 months
measure: Positive affects
timeFrame: 12 months
measure: Life quality
timeFrame: 12 months
measure: Life values
timeFrame: 12 months
measure: Mindfulness
timeFrame: 12 months
measure: Pain intensity
timeFrame: 12 months
measure: Physical effort
timeFrame: 12 months
measure: Physical suppleness
timeFrame: 12 months
measure: Physical activity level
timeFrame: 12 months
measure: Fatigue
timeFrame: 12 months
measure: Body mass index
timeFrame: 12 months
measure: Appetite quality
timeFrame: 12 months
measure: Ingested quantities
timeFrame: 12 months
measure: Eating disorders
timeFrame: 12 months
measure: Occurrence and extent of post-transplant complications and post-transplant recovery
timeFrame: 12 months
measure: Occurrence of hospitalizations
timeFrame: 12 months
measure: Post-transplant recovery
timeFrame: 12 months
Secondary outcomes:
measure: Admissibility of NewSpringForMe and its tools in terms of attractiveness, understanding, usefulness and relevance
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Service Hématologie Greffe Trèfle 3, Hôpital Saint-Louis, AP-HP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Régis Peffault de Latour, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
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