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L'essai clinique NCT07140770 pour Activité physique, Sommeil, Allogenic Hematopoietic Cell Transplant est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Sommeil et activité physique chez les dyades patient et soignant après une transplantation de cellules souches hématopoïétiques allogéniques

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT07140770 est un essai observationnel pour Activité physique, Sommeil, Allogenic Hematopoietic Cell Transplant. Son statut actuel est : en recrutement. L'étude a débuté le 2 septembre 2025 et vise à recruter 66 participants. Dirigé par le Centre médical MD Anderson, l'essai devrait être terminé d'ici le 1 avril 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 11 septembre 2025.
Résumé succinct
To understand the changes in health-related quality of life of patients and caregivers after allogeneic hematopoietic cell transplantation.
Description détaillée

Primary Objectives

  • Assess the feasibility and acceptability of obtaining objective sleep and physical activity measures in participants receiving allogeneic HCT and their caregivers during hospitalization (T2), and after discharge (T3) using Fitbits.
  • Feasibility will be determined by the percentage of participants and caregivers who wear the Fitbit Inspire 3 for sleep and physical activity data at T2, and T3. For the purposes of this study, if ≥70% of participants and caregivers will wear the Fitbit for 5 of 7 nights for sleep data and at least 10 hours during waking hours for 5 of 7 days for physical activity data at both data collection periods, the study will be determined to be feasible. Feasibility will be reported for participants and caregivers separately and will include the percentage of eligible participants who are approached, agree to participate, and complete research activities.

Secondary Objectives

  • Examine trends in objectively measured sleep, physical activity, and frailty, and participant-reported sleep disturbance, sleep-related impairment, anxiety, depression, fatigue, cancer treatment distress, and quality of life in allogeneic HCT participants and their caregivers during hospitalization (T2), and after discharge (T3).
  • Hypothesis 1: HCT participants will demonstrate improvements in objectively measured sleep, physical activity, and frailty, and participant-reported sleep disturbance, sleep-related impairment, anxiety, depression, fatigue, and cancer treatment distress from T2 to T3.
  • Compare objectively measured sleep and physical activity, and participant-reported sleep disturbance, sleep-related impairment, anxiety, depression, fatigue, cancer treatment distress, and quality of life between allogeneic HCT participants and their caregivers during hospitalization (T2), and after discharge (T3).
  • Hypothesis: HCT participants will demonstrate significant improvements compared to their caregivers in objectively measured sleep and physical activity, and patient-reported sleep disturbance, sleep-related impairment, anxiety, depression, fatigue, cancer treatment distress, and quality of life.
  • Acceptability will be assessed using an investigator-developed instrument, the Physical Activity and Sleep Tracker Acceptability Survey.
Titre officiel

Sleep and Physical Activity in Patient and Caregiver Dyads Following Allogeneic Hematopoietic Cell Transplantation

Conditions
Activité physiqueSommeilAllogenic Hematopoietic Cell Transplant
Autres identifiants de l'essai
  • 2025-0317
  • NCI-2025-06207 (Autre Identifiant) (NCI-CTRP Clinical Registry)
Numéro NCT
NCT07140770
Date de début (réel)
2025-09-02
Dernière mise à jour publiée
2025-09-11
Date de fin (estimée)
2028-04-01
Inscription (estimée)
66
Type d'essai
Observationnel
Statut
En recrutement
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
N/A
FitBit
You will wear the tracker on your wrist like a watch and it will continuously (non-stop) monitor your activity, sleep, and heart rate. Functional testing will be completed with a research team member and will consist of 2 tests: testing your grip strength by having you squeeze a measuring device 3 times with your dominant hand and measuring how many minutes it takes for you to walk 15 feet.
Questionnaire
Complete questionnaires at 3 timepoints, at the time of enrollment on the day of allogeneic hematopoietic cell transplantation, 8 days after allogeneic hematopoietic cell transplantation, and 7 days after hospital discharge.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Quality of Life Questionnaire
You will answer questionnaires with a member of the research team. The questionnaires will take about 35 minutes complete. You will be asked questions about your sleep, anxiety and depressive symptoms, fatigue, distress, and your quality of life.
Through study completion; an average of 1 year
Critères d'éligibilité

Eligibility Criteria

  • Participants and caregivers ages 18 years and older.

  • Participants diagnosed with a hematologic malignancy with a scheduled allogeneic HCT.

  • Caregivers identified by participant as the primary caregiver.

  • Participants and caregivers able to read, speak, and consent in English.

  • Participants and caregivers able to understand and be willing to sign a written informed consent document.

  • Participants and caregivers must have internet access via smart phone or tablet with the capacity to 1) download the Fitbit app and 2) complete study assessments with study

  • Participant or caregiver unable to provide consent, such as cognitively impaired individuals

  • Participant or caregiver with a diagnosis of sleep apnea.

  • Primary caregiver is a paid professional, such as a live-in Registered Nurse.

  • Participant has multiple caregivers and is unable to identify one primary caregiver.

M.D. Anderson Cancer Center logoCentre médical MD Anderson1128 essais cliniques actifs à explorer
Contact central de l'essai
Contact: Eileen D Hacker, MD, 713-563-4004, [email protected]
1 Centres de l'essai dans 1 pays

Texas

MD Anderson Cancer Center, Houston, Texas, 77030, United States
Eileen D Hacker, MD, Contact, 713-563-4004, [email protected]
Eileen D Hacker, MD, Investigateur principal
En recrutement