Evaluating Stress Management Among Allogeneic HCT Caregivers

NCT05078229 | Active Not Recruiting

• 2 other identifiers: MCC-20786R01CA255265
• Study Type: interventional
• Target: 505
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• Patient Healthcare Utilization - Readmissions to the hospital at 6 Month Follow-up

  6 Month Follow-up after end of treatment

• Patient Healthcare Utilization - unexpected clinic visits post discharge at 6 Month Follow-up

  6 Month Follow-up after end of treatment

Study Arms (3)

FOCUS

EXPERIMENTAL

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

Healthy Living

ACTIVE COMPARATOR

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

Standard of Care - Enhanced Care

NO 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.

Interventions

FOCUS 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.

FOCUS

Healthy Living 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.

Healthy Living

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• 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.

  PMID: 35363799 DERIVED

Study Officials

• Christine Vinci, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: October 14, 2021
• Study Start: September 16, 2021
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2030
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)