Evaluating Stress Management Among Allogeneic HCT Caregivers

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)

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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.