Clinical trial NCT05078229: Evaluating Stress Management Among Allogeneic HCT Caregivers
Official title: Efficacy of a Mindfulness-Based Stress Management Program for Allogeneic HCT Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burden
Stress
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-10-14
Enrollment: 540
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to understand whether different stress management interventions impact stress among HCT cancer caregivers and patients.


Eligibility criteria: Inclusion Criteria:

* Caregiver Inclusion Criteria:
* Caring for a patient planning to receive an allogeneic HCT at Moffitt
* Intending to remain primary caregiver throughout patient treatment (i.e., will be the caregiver the majority of the time)
* Able to provide informed consent
* Able to read and write in English
* Owns a smartphone and is willing to download the study app
* Patient Inclusion Criteria:
* Receiving an allogeneic HCT at the cancer center
* Able to provide informed consent
* Able to read and write in English

Exclusion Criteria:

* Under 21 years of age
* Unable to provide informed consent
* Unable to read and write in English
* Caregiver is unable to remain primary caregiver throughout patient treatment
* Patient does not receive transplant at Moffitt Cancer Center

Primary outcomes:
measure: Caregiver Burden at End of Treatment
timeFrame: Up to 8 Weeks
measure: Caregiver Burden at 2 Month Follow-up
timeFrame: 2 month follow up after end of treatment
measure: Caregiver Burden at 6 Month Follow-up
timeFrame: 6 month follow up after end of treatment
measure: Patient Distress at End of Treatment (CESD)
timeFrame: Up to 8 Weeks
measure: Patient Distress at End of Treatment (GAD-7)
timeFrame: Up to 8 Weeks
measure: Patient Distress at 2 Month Follow-up (CESD)
timeFrame: 2 Month Follow-up after end of treatment
measure: Patient Distress at 2 Month Follow-up (GAD-7)
timeFrame: 2 Month Follow-up after end of treatment
measure: Patient Distress at 6 Month Follow-up (CESD)
timeFrame: 6 Month Follow-up after end of treatment
measure: Patient Distress at 6 Month Follow-up (GAD-7)
timeFrame: 6 Month Follow-up after end of treatment
Secondary outcomes:
measure: Patient Healthcare Utilization - Readmissions to the hospital at 6 Month Follow-up
timeFrame: 6 Month Follow-up after end of treatment
measure: Patient Healthcare Utilization - unexpected clinic visits post discharge at 6 Month Follow-up
timeFrame: 6 Month Follow-up after end of treatment
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Christine Vinci, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang MJ, Yepez VV, Brandon KO, Reblin M, Pidala J, Jim HSL, Meyer JS, Gore LR, Khera N, Lau P, Sauls RM, Jones SR, Vinci C. A mindfulness-based stress management program for caregivers of allogeneic hematopoietic stem cell transplant (HCT) patients: Protocol for a randomized controlled trial. PLoS One. 2022 Apr 1;17(4):e0266316. doi: 10.1371/journal.pone.0266316. eCollection 2022.