Evaluating Stress Management Among Allogeneic HCT Caregivers

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078229
• Other study ID #: MCC-20786
• Secondary ID: R01CA255265
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2021
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Sierra Washington
• Phone: 1 813-745-5178
• Email: Sierra.Washington[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burden
• Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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