Evaluation of the Impact of the Use of NewSpringForMe on Transplanted Patients' Quality of Life and Support

NCT06148610 | Unknown

• 2 other identifiers: HTC-NSFM-1212021-A03034-37
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (17)

• Negative affects

  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.

  12 months

• Positive affects

  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.

  12 months

• Life quality

  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.

  12 months

• Life values

  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.

  12 months

• Mindfulness

  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.

  12 months

• Pain intensity

  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.

  12 months

• Physical effort

  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.

  12 months

• Physical suppleness

  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.

  12 months

• Physical activity level

  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.

  12 months

• Fatigue

  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.

  12 months

• Body mass index

  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.

  12 months

• Appetite quality

  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

  12 months

• Ingested quantities

  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.

  12 months

• Eating disorders

  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.

  12 months

• Occurrence and extent of post-transplant complications and post-transplant recovery

  * 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

  12 months

• Occurrence of hospitalizations

  \- 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.

  12 months

• Post-transplant recovery

  * 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.

  12 months

Secondary Outcomes (1)

• Admissibility of NewSpringForMe and its tools in terms of attractiveness, understanding, usefulness and relevance

  12 months

Study Arms (1)

NewSpringForMe cohort

Patients with hematological diseases intended to be allotransplanted (bone marrow or Hematopoietic Stem Cells)

Device: NewSpringForMe digital solution

Interventions

NewSpringForMe digital solution DEVICE

Follow-up of transplanted patients for hematological diseases using the NewSpringForMe device as support of quality of life

NewSpringForMe cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fonds de Dotation HTC Project: lead
• Saint-Louis Hospital, Paris, France: collaborator
• Nutricia Nutrition Clinique: collaborator
• Clinicprosport: collaborator
• ELLYE: collaborator
• Association Aïda: collaborator
• Gilead Sciences: collaborator
• Pfizer: collaborator
• Groupe Apicil: collaborator
• Association Laurette Fugain: collaborator
• Fondation du LEEM: collaborator
• Fondation AFNIC: collaborator
• Pierre Fabre Medicament: collaborator
• Novartis Pharmaceuticals: collaborator
• University Hospital, Clermont-Ferrand: collaborator
• LAPSCO, Université Clermont-Auvergne: collaborator

Study Sites (1)

Service Hématologie Greffe Trèfle 3, Hôpital Saint-Louis, AP-HP

Paris, 75010, France

RECRUITING

Related Publications (6)

• Dirou S, Chambellan A, Chevallier P, Germaud P, Lamirault G, Gourraud PA, Perrot B, Delasalle B, Forestier B, Guillaume T, Peterlin P, Garnier A, Magnan A, Blanc FX, Lemarchand P. Deconditioning, fatigue and impaired quality of life in long-term survivors after allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2018 Mar;53(3):281-290. doi: 10.1038/s41409-017-0057-5. Epub 2017 Dec 21.

  PMID: 29269801 BACKGROUND

• Brotelle T, Lemal R, Cabrespine A, Combal C, Hermet E, Ravinet A, Bay JO, Bouteloup C. Prevalence of malnutrition in adult patients previously treated with allogeneic hematopoietic stem-cell transplantation. Clin Nutr. 2018 Apr;37(2):739-745. doi: 10.1016/j.clnu.2017.03.016. Epub 2017 Mar 28.

  PMID: 28390845 BACKGROUND

• Corman M, Rubio MT, Cabrespine A, Brindel I, Bay JO, Peffault De La Tour R, Dambrun M. Mental health and quality of life of patients undergoing hematopoietic stem cell transplantation (HSCT) prior to hospitalization: a cross-sectional complete state health study. Health Psychol Behav Med. 2021 Jan 28;9(1):70-83. doi: 10.1080/21642850.2021.1873140.

  PMID: 34104550 BACKGROUND

• Hoodin F, Uberti JP, Lynch TJ, Steele P, Ratanatharathorn V. Do negative or positive emotions differentially impact mortality after adult stem cell transplant? Bone Marrow Transplant. 2006 Aug;38(4):255-64. doi: 10.1038/sj.bmt.1705419. Epub 2006 Jun 19.

  PMID: 16785869 BACKGROUND

• Kisch A, Lenhoff S, Zdravkovic S, Bolmsjo I. Factors associated with changes in quality of life in patients undergoing allogeneic haematopoietic stem cell transplantation. Eur J Cancer Care (Engl). 2012 Nov;21(6):735-46. doi: 10.1111/j.1365-2354.2012.01354.x. Epub 2012 Apr 23.

  PMID: 22519415 BACKGROUND

• Snowden JA, Sanchez-Ortega I, Corbacioglu S, Basak GW, Chabannon C, de la Camara R, Dolstra H, Duarte RF, Glass B, Greco R, Lankester AC, Mohty M, Neven B, de Latour RP, Pedrazzoli P, Peric Z, Yakoub-Agha I, Sureda A, Kroger N; European Society for Blood and Marrow Transplantation (EBMT). Indications for haematopoietic cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2022. Bone Marrow Transplant. 2022 Aug;57(8):1217-1239. doi: 10.1038/s41409-022-01691-w. Epub 2022 May 19.

  PMID: 35589997 BACKGROUND

Related Links

• Description of NewSpringForMe digital solution

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Régis Peffault de Latour, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Robert, PhD

CONTACT

33 4 91 11 88 53; emilie.robert@htcproject.org

Régis Peffault de Latour, PU-PH

CONTACT

regis.peffaultdelatour@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: November 28, 2023
• Study Start: September 27, 2022
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

FR (1)