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Evaluating Stress Management Among Allogeneic HCT Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05078229
Recruitment Status : Recruiting
First Posted : October 14, 2021
Last Update Posted : October 14, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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

Condition or disease Intervention/treatment Phase
Burden Stress Behavioral: FOCUS Behavioral: Healthy Living Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Efficacy of a Mindfulness-Based Stress Management Program for Allogeneic HCT Caregivers
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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.



Primary Outcome Measures :
  1. Caregiver Burden at Baseline [ Time Frame: Baseline ]
    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". and The ZBI has been validated in populations of cancer caregivers and has demonstrated very good internal consistency and discriminative ability

  2. Caregiver Burden at End of Treatment [ Time Frame: Up to 8 Weeks ]
    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

  3. Caregiver Burden at 2 Month Follow-up [ Time Frame: 2 month follow up after 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

  4. Caregiver Burden at 6 Month Follow-up [ Time Frame: 6 month follow up after 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

  5. Patient Distress at Baseline (CESD) [ Time Frame: Baseline ]
    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. Patient Distress at Baseline (GAD-7) [ Time Frame: Baseline ]
    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

  7. Patient Distress at End of Treatment (CESD) [ Time Frame: Up to 8 Weeks ]
    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.

  8. Patient Distress at End of Treatment (GAD-7) [ Time Frame: Up to 8 Weeks ]
    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

  9. Patient Distress at 2 Month Follow-up (CESD) [ Time Frame: 2 Month Follow-up after end of treatment ]
    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.

  10. Patient Distress at 2 Month Follow-up (GAD-7) [ Time Frame: 2 Month Follow-up after end of treatment ]
    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

  11. Patient Distress at 6 Month Follow-up (CESD) [ Time Frame: 6 Month Follow-up after end of treatment ]
    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.

  12. Patient Distress at 6 Month Follow-up (GAD-7) [ Time Frame: 6 Month Follow-up after end of treatment ]
    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


Secondary Outcome Measures :
  1. Caregiver Distress at Baseline (CESD) [ Time Frame: Baseline ]
    Caregiver 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. Caregiver Distress at Baseline (GAD-7) [ Time Frame: Baseline ]
    Caregiver 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

  3. Caregiver Distress at Baseline (PTGI) [ Time Frame: Baseline ]
    Caregiver distress will be measured using the Post Traumatic Growth Inventory (PTGI). The PTGI is comprised of 21 item measure on a 6-point Likert scale, 0 being "I did not experience this change as a result of my crisis" and 5 being "I experienced this change to a very great degree as a result of my crisis". It will evaluate the caregiver's assessment of any positive outcomes that may have been due to the patient receiving a diagnosis and treatment for cancer.

  4. Caregiver Distress at End of Treatment (CESD) [ Time Frame: Up to 8 Weeks ]
    Caregiver 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.

  5. Caregiver Distress at End of Treatment (GAD-7) [ Time Frame: Up to 8 Weeks ]
    Caregiver 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. Caregiver Distress at End of Treatment (PTGI) [ Time Frame: Up to 8 Weeks ]
    Caregiver distress will be measured using the Post Traumatic Growth Inventory (PTGI). The PTGI is comprised of 21 item measure on a 6-point Likert scale, 0 being "I did not experience this change as a result of my crisis" and 5 being "I experienced this change to a very great degree as a result of my crisis". It will evaluate the caregiver's assessment of any positive outcomes that may have been due to the patient receiving a diagnosis and treatment for cancer.

  7. Caregiver Distress at 2 Month Follow-up (CESD) [ Time Frame: 2 Month Follow-up after end of treatment ]
    Caregiver 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.

  8. Caregiver Distress at 2 Month Follow-up (GAD-7) [ Time Frame: 2 Month Follow-up after end of treatment ]
    Caregiver 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

  9. Caregiver Distress at 2 Month Follow-up (PTGI) [ Time Frame: 2 Month Follow-up after end of treatment ]
    Caregiver distress will be measured using the Post Traumatic Growth Inventory (PTGI). The PTGI is comprised of 21 item measure on a 6-point Likert scale, 0 being "I did not experience this change as a result of my crisis" and 5 being "I experienced this change to a very great degree as a result of my crisis". It will evaluate the caregiver's assessment of any positive outcomes that may have been due to the patient receiving a diagnosis and treatment for cancer.

  10. Caregiver Distress at 6 Month Follow-up (CESD) [ Time Frame: 6 Month Follow-up after end of treatment ]
    .Caregiver 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.

  11. Caregiver Distress at 6 Month Follow-up (GAD-7) [ Time Frame: 6 Month Follow-up after end of treatment ]
    Caregiver 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

  12. Caregiver Distress at 6 Month Follow-up (PTGI) [ Time Frame: 6 Month Follow-up after end of treatment ]
    Caregiver distress will be measured using the Post Traumatic Growth Inventory (PTGI). The PTGI is comprised of 21 item measure on a 6-point Likert scale, 0 being "I did not experience this change as a result of my crisis" and 5 being "I experienced this change to a very great degree as a result of my crisis". It will evaluate the caregiver's assessment of any positive outcomes that may have been due to the patient receiving a diagnosis and treatment for cancer.


Other Outcome Measures:
  1. Patient Healthcare Utilization - Readmissions to the hospital [ Time Frame: Up to 8 Weeks ]
    Patient Healthcare Utilization will be measured with readmissions to the hospital information extracted from the patient charts.

  2. Patient Healthcare Utilization - length of stay of all hospital readmissions [ Time Frame: Up to 8 Weeks ]
    Patient Healthcare Utilization will be measured with length of stay of all hospital readmissions extracted from the patient charts.

  3. Patient Healthcare Utilization - unexpected clinic visits post discharge [ Time Frame: Up to 8 Weeks ]
    Patient Healthcare Utilization will be measured with unexpected clinic visits post discharge extracted from the patient charts.

  4. Patient Healthcare Utilization - Readmissions to the hospital at 2 Month Follow-up [ Time Frame: 2 Month Follow-up after end of treatment ]
    Patient Healthcare Utilization will be measured with readmissions to the hospital information extracted from the patient charts.

  5. Patient Healthcare Utilization - length of stay of all hospital readmissions at 2 Month Follow-up [ Time Frame: 2 Month Follow-up after end of treatment ]
    Patient Healthcare Utilization will be measured with length of stay of all hospital readmissions extracted from the patient charts.

  6. Patient Healthcare Utilization - unexpected clinic visits post discharge at 2 Month Follow-up [ Time Frame: 2 Month Follow-up after end of treatment ]
    Patient Healthcare Utilization will be measured with unexpected clinic visits post discharge extracted from the patient charts.

  7. Patient Healthcare Utilization - Readmissions to the hospital at 6 Month Follow-up [ Time Frame: 6 Month Follow-up after end of treatment ]
    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.

  8. Patient Healthcare Utilization - length of stay of all hospital readmissions at 6 Month Follow-up [ Time Frame: 6 Month Follow-up after end of treatment ]
    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.

  9. Patient Healthcare Utilization - unexpected clinic visits post discharge at 6 Month Follow-up [ Time Frame: 6 Month Follow-up after end of treatment ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05078229


Contacts
Layout table for location contacts
Contact: Karen Brandon 1 813-745-7691 Karen.Brandon@moffitt.org
Contact: Christine Vinci, PhD 1 813-745-7691 Christine.Vinci@moffitt.org

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Karen Brandon    813-745-7691    Karen.Brandon@moffitt.org   
Contact: Christine Vinci, PhD    1 813-745-7691    Christine.Vinci@moffitt.org   
Principal Investigator: Christine Vinci, PhD         
Sub-Investigator: Joseph Pidala, MD PhD         
Sub-Investigator: Heather Jim, PhD         
Sub-Investigator: Robert Gore, PhD         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Christine Vinci, PhD Moffitt Cancer Center
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT05078229    
Other Study ID Numbers: MCC-20786
R01CA255265 ( U.S. NIH Grant/Contract )
First Posted: October 14, 2021    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No