This is a clinical trial examines the effectiveness of a mindfulness-based intervention in managing stress in hematopoietic stem cell transplant caregivers. Mindfulness-based interventions focus on building awareness of thoughts, emotions/feelings, and the sensations. This study may help improve mental well-being and reduce stress and anxiety associated with caring for a hematopoietic stem cell transplant patient.
Additional locations may be listed on ClinicalTrials.gov for NCT05078229.
Locations matching your search criteria
United States
Florida
Tampa
Moffitt Cancer CenterStatus: Active
Contact: Christine Vinci
Phone: 813-745-5421
PRIMARY OBJECTIVES:
I. Evaluate the efficacy of Focusing On mindfulness for Caregivers Under Stress (FOCUS) when compared to usual care (UC) and healthy living (HL) on caregiver burden.
II. Evaluate the impact of FOCUS on patient health and patient healthcare utilization.
III. Evaluate putative mechanisms and moderators of FOCUS.
OUTLINE:
Phase I: Prepare and finalize study procedures over 3 months.
Phase II: Caregivers are randomized to 1 of 3 groups.
GROUP I: Participants receive FOCUS intervention consisting of 6 session over 45-60 minutes of 8 weeks. Participants may optionally undergo blood sample collection on study.
GROUP II: Participants receive healthy living intervention over 8 weeks.
GROUP III: Participants receive usual care over 8 weeks. Participants may optionally undergo blood sample collection on study.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorChristine Vinci
