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Stress Management for Caregiver Stress

N/A
Recruiting
Led By Christine Vinci, PhD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Caring for a patient planning to receive an allogeneic HCT at Moffitt
Receiving an allogeneic HCT at the cancer center
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month follow-up after end of treatment
Awards & highlights

Study Summary

This trial is testing whether different stress management interventions help relieve stress in caregivers and patients of those undergoing hematopoietic cell transplantation (HCT).

Who is the study for?
This trial is for English-reading individuals who are primary caregivers to patients scheduled for allogeneic HCT at Moffitt Cancer Center. They must own a smartphone, be willing to use a study app, and plan to remain the main caregiver throughout treatment.Check my eligibility
What is being tested?
The study is testing two stress management methods: Healthy Living guidelines and FOCUS program, aiming to see their effect on reducing stress in caregivers of allogeneic HCT cancer patients.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like lifestyle guidance and focus exercises, traditional side effects associated with medications are not expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am caring for someone getting a donor stem cell transplant at Moffitt.
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I am getting a stem cell transplant from a donor at the cancer center.
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I own a smartphone and agree to download the study app.
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I plan to be the main caregiver during the patient's treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month follow-up after end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month follow-up after end of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Caregiver Burden at 2 Month Follow-up
Caregiver Burden at 6 Month Follow-up
Caregiver Burden at End of Treatment
+6 more
Secondary outcome measures
Patient Healthcare Utilization - Readmissions to the hospital at 6 Month Follow-up
Patient Healthcare Utilization - unexpected clinic visits post discharge at 6 Month Follow-up
Other outcome measures
Patient Healthcare Utilization - Readmissions to the hospital
Patient Healthcare Utilization - Readmissions to the hospital at 2 Month Follow-up
Patient Healthcare Utilization - length of stay of all hospital readmissions
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: FOCUSExperimental Treatment1 Intervention
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 II: Healthy LivingActive Control1 Intervention
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 III: Standard of Care - Enhanced CareActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOCUS
2013
N/A
~540

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
540 Previous Clinical Trials
134,895 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,926,807 Total Patients Enrolled
Christine Vinci, PhDPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
2,149 Total Patients Enrolled

Media Library

FOCUS Clinical Trial Eligibility Overview. Trial Name: NCT05078229 — N/A
Stress Research Study Groups: Healthy Living, FOCUS, Standard of Care - Enhanced Care
Stress Clinical Trial 2023: FOCUS Highlights & Side Effects. Trial Name: NCT05078229 — N/A
FOCUS 2023 Treatment Timeline for Medical Study. Trial Name: NCT05078229 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the goal of this clinical research endeavor?

"This clinical trial will primarily assess Patient Distress at 2 Month Follow-up (CESD) over the course of up to 8 weeks. Secondary outcomes include Caregiver Distress at End of Treatment (CESD), which is evaluated through a 20-item 4-point Likert scale, and Caregiver Distress at Baseline (PTGI), assessed via a 21 item 6-point Likert scale measure. Additionally, Caregiver Distress at 2 Month Follow Up (GAD-7) – an 8 questions survey on a 4 point Likert Scale - allows participants to rate the severity of"

Answered by AI

How many test subjects are engaged in this clinical experiment?

"Affirmative. Clinicaltrials.gov contains information that this clinical trial is currently recruiting, with the first post being published on September 16th 2021 and last updated July 27th 2022. 540 patients are in need of recruitment from a single site."

Answered by AI

Are individuals still able to join this experiment?

"Affirmative. According to the clinicaltrials.gov website, this medical research is still recruiting participants for enrolment. The trial was initially posted on September 16th 2021 and updated most recently on July 27th 2022; 540 individuals need to be enrolled at 1 site in total."

Answered by AI
~240 spots leftby Mar 2026