Evaluating Stress Management Among Allogeneic HCT Caregivers

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05078229
Collaborator
National Cancer Institute (NCI) (NIH)
540
1
3
54.4
9.9

Study Details

Study Description

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
  • Behavioral: FOCUS
  • Behavioral: Healthy Living
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
540 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of a Mindfulness-Based Stress Management Program for Allogeneic HCT Caregivers
Actual Study Start Date :
Sep 16, 2021
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Mar 31, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Caregiver Burden at Baseline [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 [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 [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 [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Moffitt Cancer Center Tampa Florida United States 33612

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Christine Vinci, PhD, Moffitt Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT05078229
Other Study ID Numbers:
  • MCC-20786
  • R01CA255265
First Posted:
Oct 14, 2021
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 28, 2022