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Evaluating Stress Management Among Allogeneic HCT Caregivers

H. Lee Moffitt Cancer Center and Research Institute logo

H. Lee Moffitt Cancer Center and Research Institute

Status

Enrolling

Conditions

Burden
Stress

Treatments

Behavioral: FOCUS
Behavioral: Healthy Living

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05078229
MCC-20786
R01CA255265 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment

540 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

540 participants in 3 patient groups

FOCUS
Experimental group
Description:
Focusing On mindfulness for Caregivers Under Stress (FOCUS)will consist of six one-on-one, 45-60 minute sessions delivered either in-person (sessions 1-3) or via video conference (sessions 4-6). The first few sessions will primarily focus on how to direct attention to the breath or some object of attention (e.g., parts of the body). As the program progresses, participants are asked to apply these skills to thoughts and emotions. Throughout the treatment, caregivers are reminded to utilize existing coping skills, as well as how to integrate the new skills learned throughout this program for managing stress. Formal mindfulness meditations are conducted within each session, lasting from 7-20 minutes; participants will be asked to practice mindfulness exercises daily.
Treatment:
Behavioral: FOCUS
Healthy Living
Active Comparator group
Description:
Healthy Living (HL) will consist of six, 45-60 minute sessions delivered one-on-one; sessions 1-3 in-person on HCT unit and sessions 4-6 via video conference. HL will be based on the American Cancer Society's (ACS) Caregiver Resource Guide.
Treatment:
Behavioral: Healthy Living
Standard of Care - Enhanced Care
No Intervention group
Description:
Participants in Enhanced Care will receive treatment consistent with what is offered to all caregivers of allogeneic HCT patients. This entails the option of attending weekly support groups and meeting with social workers as needed. At the baseline session, participants randomized to Enhanced Care will be provided with a modified version of the ACS Caregiver Resource Guide.

Trial contacts and locations

1

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Central trial contact

Sierra Washington; Christine Vinci, PhD

Data sourced from clinicaltrials.gov

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