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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Life values
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Life values
时间窗: 12 months
Identification of life values (Valued Living Questionnaire, Wilson \& Groom, 2002). 10-item scale (from 1 "not at all important" to 10 "very important"). Data will be collected at each connection and each time the platform and spaces are used. However, a connection to the platform and to the psychology, nutrition and physical activity spaces will be required at times defined as follows, in order to allow data collection on basic times applicable to all patients and to allow a relevant assessment.
Pain intensity
时间窗: 12 months
Simple Verbal Scale (EVS) for assessing pain intensity (from 0 "no pain" to 10 "maximum pain imaginable") Data will be collected at each connection and each time the platform and spaces used. However, a connection to the platform and to the psychology, nutrition and physical activity spaces will be required at times defined as follows, in order to allow data collection on basic times applicable to all patients and to allow a relevant assessment.
Physical suppleness
时间窗: 12 months
Shoulder flexibility test and lower limb spine test (in centimeters). For the shoulder test, the distance is calculated between the two hands located behind the back of the individual performing the test. For the lower limb spine test, the distance measured is the finger-to-ground distance. Data will be collected at each connection and each time the platform and spaces are used. However, a connection to the platform and to the psychology, nutrition and physical activity spaces will be required at times defined as follows, in order to allow data collection on basic times applicable to all patients and to allow a relevant assessment.
Positive affects
时间窗: 12 months
Level of positive affects (SA-DHS, Subjective Authentic Durable Happiness Scale, Dambrun et al., 2012). Scale of 13 items (from 1 "very low" to 7 "very high") measuring the level of well-being. Data will be collected at each connection and each time the platform and spaces are used. However, a connection to the platform and to the psychology, nutrition and physical activity spaces will be required at times defined as follows, in order to allow data collection on basic times applicable to all patients and to allow a relevant assessment.
Life quality
时间窗: 12 months
Quality of life (SF-12, Gandek, Ware \& Aronson, 1998) Data will be collected at each connection and each time the platform and spaces are used. However, a connection to the platform and to the psychology, nutrition and physical activity spaces will be required at times defined as follows, in order to allow data collection on basic times applicable to all patients and to allow a relevant assessment.
Body mass index
时间窗: 12 months
Function of the weight in kg and the height in m Data will be collected at each connection and each time the platform and spaces are used. However, a connection to the platform and to the psychology, nutrition and physical activity spaces will be required at times defined as follows, in order to allow data collection on basic times applicable to all patients and to allow a relevant assessment.
Appetite quality
时间窗: 12 months
Using a scale Data will be collected at each connection and each time the platform and spaces are used. However, a connection to the platform and to the psychology, nutrition and physical activity spaces will be required at times defined as follows, in order to allow data collection on basic times applicable to all patients and to allow a relevant assessment
Negative affects
时间窗: 12 months
Level of negative affect (PHQ, Patient Health Questionnaire, Spitzer et al., 2006). Scales measuring sad mood in 9 items (from 0 "never" to 3 "almost every day") and anxious mood in 7 items (from 0 "never" to 3 "almost every day"). Simple Verbal Scale (EVS) for assessing pain intensity (from 0 "no pain" to 10 "maximum pain imaginable"). Data will be collected at each connection and each time the platform and spaces are used. However, a connection to the platform and to the psychology, nutrition and physical activity spaces will be required at times defined as follows, in order to allow data collection on basic times applicable to all patients and to allow a relevant assessment.
Mindfulness
时间窗: 12 months
Level of dispositional mindfulness (FFMQ-15, 15 item Five Facets Mindfulness Questionnaire, Baer et al., 2008; Gu et al., 2016) in 15 items (from 1 "never true" to 5 "always true") Data will be collected at each connection and each time the platform and spaces are used. However, a connection to the platform and to the psychology, nutrition and physical activity spaces will be required at times defined as follows, in order to allow data collection on basic times applicable to all patients and to allow a relevant assessment.
Physical effort
时间窗: 12 months
Stress test: TM6 walking test (distance in meters measured for 6 minutes) Data will be collected at each connection and each time the platform and spaces are used. However, a connection to the platform and to the psychology, nutrition and physical activity spaces will be required at times defined as follows, in order to allow data collection on basic times applicable to all patients and to allow a relevant assessment.
Fatigue
时间窗: 12 months
Fatigue assessed by the Pichot scale (see "Scales and assessment tools in general medicine" J. Gardenas et Coll. -Le Généraliste- Supplement to No. 2187; March 2002). This scale allows you to calculate the level of fatigue (from 0 not at all to 4 extremely). It includes 8 items: "I lack energy", "everything requires effort", "I feel weak in certain parts of the body", "my arms or legs are heavy", "I feel tired without reason", "I want to lie down to rest", "I have difficulty concentrating", "I feel tired, heavy and stiff". Data will be collected at each connection and each time the platform and spaces are used. However, a connection to the platform and to the psychology, nutrition and physical activity spaces will be required at times defined as follows, in order to allow data collection on basic times applicable to all patients and to allow a relevant assessment.
Physical activity level
时间窗: 12 months
Level of physical activity using a specific self-assessment questionnaire (see J. Ricci and L. Gagnon, University of Montreal, modified by F. Laureyns and JM. Séné) to measure physical activity and determine a profile (inactive, active, very active) depending on the score (ranging from 0 to 5). Data will be collected at each connection and each time the platform and spaces are used. However, a connection to the platform and to the psychology, nutrition and physical activity spaces will be required at times defined as follows, in order to allow data collection on basic times applicable to all patients and to allow a relevant assessment.
Ingested quantities
时间窗: 12 months
Food intake using the food intake assessment tool (EPA). Data will be collected at each connection and each time the platform and spaces are used. However, a connection to the platform and to the psychology, nutrition and physical activity spaces will be required at times defined as follows, in order to allow data collection on basic times applicable to all patients and to allow a relevant assessment.
Post-transplant recovery
时间窗: 12 months
* Overall survival * Occurrence of relapse * Recovery These data relating to post-transplant complications will not be collected from the NewSpringForMe platform but collected from the patient's medical file by the team caregiver. They will be aggregated to arrive to a final score combining their values.
Eating disorders
时间窗: 12 months
Occurrence of eating disorders such as nausea, vomiting, inappetence, dysgesia, dysphagia Data will be collected at each connection and each time the platform and spaces are used. However, a connection to the platform and to the psychology, nutrition and physical activity spaces will be required at times defined as follows, in order to allow data collection on basic times applicable to all patients and to allow a relevant assessment.
Occurrence and extent of post-transplant complications and post-transplant recovery
时间窗: 12 months
* Nature, frequency of occurrence and extent of post-transplant complications. * Number of therapeutic protocols initiated to treat complications These data relating to post-transplant complications will not be collected from the NewSpringForMe platform but collected from the patient's medical file by the team caregiver. All these outcomes will be aggregated to achieve a final score related to the post-transplant complications
Occurrence of hospitalizations
时间窗: 12 months
- Average cumulative duration (in days) of unscheduled hospitalizations These data relating to post-transplant complications will not be collected from the NewSpringForMe platform but collected from the patient's medical file by the team caregiver.
次要结局
- Admissibility of NewSpringForMe and its tools in terms of attractiveness, understanding, usefulness and relevance(12 months)