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O estudo clínico NCT07140770 para Atividade física, Sono, Allogenic Hematopoietic Cell Transplant está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Sleep and Physical Activity in Patient and Caregiver Dyads Following Allogeneic Hematopoietic Cell Transplantation

Recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07140770 é um ensaio observacional para Atividade física, Sono, Allogenic Hematopoietic Cell Transplant. Seu status atual é: recrutando. O estudo começou em 2 de setembro de 2025 e pretende incluir 66 participantes. Coordenado por o Centro de Câncer MD Anderson e deve ser concluído em 1 de abril de 2028. Essas informações foram atualizadas no ClinicalTrials.gov em 11 de setembro de 2025.
Resumo
To understand the changes in health-related quality of life of patients and caregivers after allogeneic hematopoietic cell transplantation.
Descrição detalhada

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.
Título oficial

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

Condições
Atividade físicaSonoAllogenic Hematopoietic Cell Transplant
Outros IDs do estudo
  • 2025-0317
  • NCI-2025-06207 (Outro identificador) (NCI-CTRP Clinical Registry)
Número NCT
NCT07140770
Data de início (real)
2025-09-02
Última atualização postada
2025-09-11
Data de conclusão (estimada)
2028-04-01
Inscrição (estimada)
66
Tipo de estudo
Observacional
Status
Recrutando
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
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.
Questionário
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.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Critérios de elegibilidade

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 logoCentro de Câncer MD Anderson1128 estudos clínicos ativos para explorar
Contato central do estudo
Contato: Eileen D Hacker, MD, 713-563-4004, [email protected]
1 Locais do estudo em 1 países

Texas

MD Anderson Cancer Center, Houston, Texas, 77030, United States
Eileen D Hacker, MD, Contato, 713-563-4004, [email protected]
Eileen D Hacker, MD, Investigador principal
Recrutando