Evaluating Stress Management Among Allogeneic HCT Caregivers

Efficacy of a Mindfulness-Based Stress Management Program for Allogeneic HCT Caregivers

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

Study Overview

• Status: Recruiting
• Conditions: Stress; Burden
• Intervention / Treatment: Behavioral: FOCUS; Behavioral: Healthy Living

• Study Type: Interventional
• Enrollment (Estimated): 540
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sierra Washington; Phone Number: 1 813-745-5178; Email: Sierra.Washington@moffitt.org
• Study Contact Backup: Name: Christine Vinci, PhD; Phone Number: 1 813-745-7691; Email: Christine.Vinci@moffitt.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Sub-Investigator: Heather Jim, PhD
      • Principal Investigator: Christine Vinci, PhD
      • Sub-Investigator: Joseph Pidala, MD PhD
      • Sub-Investigator: Robert Gore, PhD
      • Contact: Sierra Washington; Phone Number: 813-745-5178; Email: sierra.washington@moffitt.org
      • Contact: Christine Vinci, PhD; Phone Number: 813-745-5178; Email: Christine.Vinci@moffitt.org
      • Sub-Investigator: Karen Brandon
      • Sub-Investigator: Marilyn Horta, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Burden at End of Treatment	Caregiver burden will be measured using the Zarit Burden Interview Short Form (ZBI). The ZBI is 12 items using a 5-point Likert scale assessing caregiver burden. Participants rate burden on a scale of 0 to 4, 0 indicating "rarely" an issue and 4 indicating "nearly always" The ZBI has been validated in populations of cancer caregivers and has demonstrated very good internal consistency and discriminative ability	Up to 8 Weeks
Caregiver Burden at 2 Month Follow-up	Caregiver burden will be measured using the Zarit Burden Interview Short Form (ZBI). The ZBI is 12 items using a 5-point Likert scale assessing caregiver burden. Participants rate burden on a scale of 0 to 4, 0 indicating "rarely" an issue and 4 indicating "nearly always". The ZBI has been validated in populations of cancer caregivers and has demonstrated very good internal consistency and discriminative ability	2 month follow up after end of treatment
Caregiver Burden at 6 Month Follow-up	Caregiver burden will be measured using the Zarit Burden Interview Short Form (ZBI). The ZBI is 12 items using a 5-point Likert scale assessing caregiver burden. Participants rate burden on a scale of 0 to 4, 0 indicating "rarely" an issue and 4 indicating "nearly always". The ZBI has been validated in populations of cancer caregivers and has demonstrated very good internal consistency and discriminative ability	6 month follow up after end of treatment
Patient Distress at End of Treatment (CESD)	Patient distress will be measured using the Center for Epidemiological Studies Depression Scale (CESD). The CESD is comprised of 20 4-point Likert scale items and has been commonly used among cancer caregivers. Participants rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.	Up to 8 Weeks
Patient Distress at End of Treatment (GAD-7)	Patient distress will be measured using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is comprised of 8 items on a 4-point Likert scale and has been used extensively among cancer caregivers. Participants rate the severity of his or her symptoms over the past two weeks. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions	Up to 8 Weeks
Patient Distress at 2 Month Follow-up (CESD)	Patient distress will be measured using the Center for Epidemiological Studies Depression Scale (CESD). The CESD is comprised of 20 4-point Likert scale items and has been commonly used among cancer caregivers. Participants rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.	2 Month Follow-up after end of treatment
Patient Distress at 2 Month Follow-up (GAD-7)	Patient distress will be measured using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is comprised of 8 items on a 4-point Likert scale and has been used extensively among cancer caregivers. Participants rate the severity of his or her symptoms over the past two weeks. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions	2 Month Follow-up after end of treatment
Patient Distress at 6 Month Follow-up (CESD)	Patient distress will be measured using the Center for Epidemiological Studies Depression Scale (CESD). The CESD is comprised of 20 4-point Likert scale items and has been commonly used among cancer caregivers. Participants rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.	6 Month Follow-up after end of treatment
Patient Distress at 6 Month Follow-up (GAD-7)	Patient distress will be measured using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is comprised of 8 items on a 4-point Likert scale and has been used extensively among cancer caregivers. Participants rate the severity of his or her symptoms over the past two weeks. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions	6 Month Follow-up after end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Healthcare Utilization - Readmissions to the hospital at 6 Month Follow-up	Patient Healthcare Utilization will be measured with readmissions to the hospital	6 Month Follow-up after end of treatment
Patient Healthcare Utilization - unexpected clinic visits post discharge at 6 Month Follow-up	Patient Healthcare Utilization will be measured with unexpected clinic visits post discharge	6 Month Follow-up after end of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Healthcare Utilization - Readmissions to the hospital	Patient Healthcare Utilization will be measured with readmissions to the hospital information extracted from the patient charts.	Up to 8 Weeks
Patient Healthcare Utilization - length of stay of all hospital readmissions	Patient Healthcare Utilization will be measured with length of stay of all hospital readmissions extracted from the patient charts.	Up to 8 Weeks
Patient Healthcare Utilization - unexpected clinic visits post discharge	Patient Healthcare Utilization will be measured with unexpected clinic visits post discharge extracted from the patient charts.	Up to 8 Weeks
Patient Healthcare Utilization - Readmissions to the hospital at 2 Month Follow-up	Patient Healthcare Utilization will be measured with readmissions to the hospital information extracted from the patient charts.	2 Month Follow-up after end of treatment
Patient Healthcare Utilization - length of stay of all hospital readmissions at 2 Month Follow-up	Patient Healthcare Utilization will be measured with length of stay of all hospital readmissions extracted from the patient charts.	2 Month Follow-up after end of treatment
Patient Healthcare Utilization - unexpected clinic visits post discharge at 2 Month Follow-up	Patient Healthcare Utilization will be measured with unexpected clinic visits post discharge extracted from the patient charts.	2 Month Follow-up after end of treatment
Patient Healthcare Utilization - Readmissions to the hospital at 6 Month Follow-up	Patient Healthcare Utilization will be measured with readmissions to the hospital information extracted from the patient charts, but self report and supplementation with outside records will also be done in cases when the patient is no longer seen at Moffitt Cancer Center.	6 Month Follow-up after end of treatment
Patient Healthcare Utilization - length of stay of all hospital readmissions at 6 Month Follow-up	Patient Healthcare Utilization will be measured with length of stay of all hospital readmissions extracted from the patient charts, but self report and supplementation with outside records will also be done in cases when the patient is no longer seen at Moffitt Cancer Center.	6 Month Follow-up after end of treatment
Patient Healthcare Utilization - unexpected clinic visits post discharge at 6 Month Follow-up	Patient Healthcare Utilization will be measured with unexpected clinic visits post discharge extracted from the patient charts, but self report and supplementation with outside records will also be done in cases when the patient is no longer seen at Moffitt Cancer Center.	6 Month Follow-up after end of treatment

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Christine Vinci, PhD, Moffitt Cancer Center

Publications and helpful links

General Publications

• 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. Erratum In: PLoS One. 2022 Sep 23;17(9):e0275398.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MCC-20786; R01CA255265 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No