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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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 month follow-up after end of treatment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Caregiver Burden at 2 Month Follow-up

Caregiver Burden at 6 Month Follow-up

Caregiver Burden at End of Treatment

+6 more

Secondary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met