Evaluating Stress Management Among Allogeneic HCT Caregivers

NCT ID: NCT05078229

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 505 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-16
• Study Completion Date: 2026-03-31

Brief Summary

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

Conditions

Burden; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FOCUS

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.

Group Type: EXPERIMENTAL

FOCUS

Intervention Type: BEHAVIORAL

There will be 6 one on one sessions, either in person or via video conference. The 6 sessions will last between 45-60 minutes. Topics of the sessions will be Mindfulness for the Caregivers, Awareness of Stressors, Skillful Actions, Thoughts, Self-Care and Balance and Planning for the Future. There will be meditation during the sessions and then recommended daily at home mindfulness practice.

Healthy Living

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.

Group Type: ACTIVE_COMPARATOR

Healthy Living

Intervention Type: BEHAVIORAL

There will be 6 one on one sessions, either in person or via video conference. The 6 sessions will last between 45-60 minutes. Topics of sessions will be Overview of Cancer, Eating Well, Exercise, Cancer Prevention, Sleep and Finances.

Standard of Care - Enhanced Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FOCUS

There will be 6 one on one sessions, either in person or via video conference. The 6 sessions will last between 45-60 minutes. Topics of the sessions will be Mindfulness for the Caregivers, Awareness of Stressors, Skillful Actions, Thoughts, Self-Care and Balance and Planning for the Future. There will be meditation during the sessions and then recommended daily at home mindfulness practice.

Intervention Type: BEHAVIORAL

Healthy Living

There will be 6 one on one sessions, either in person or via video conference. The 6 sessions will last between 45-60 minutes. Topics of sessions will be Overview of Cancer, Eating Well, Exercise, Cancer Prevention, Sleep and Finances.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Vinci, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Moffitt Cancer Center

Tampa, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35363799 (View on PubMed)

Other Identifiers

R01CA255265

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-20786

Identifier Type: -

Identifier Source: org_study_id