BurdenNCT05078229
Evaluating Stress Management Among Allogeneic HCT Caregivers
A study testing FOCUS and Healthy Living in people with Burden and Stress, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to understand whether different stress management interventions impact stress among HCT cancer caregivers and patients. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- What is being tested?
- FOCUS and Healthy Living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 505 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2021to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Patient Inclusion Criteria:
- Receiving an allogeneic HCT at the cancer center
- Able to provide informed consent
- Able to read and write in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- FOCUS, Healthy Living
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOCUSBehavioural
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 LivingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 6 Month Follow-up after end of treatment
Secondary outcomes (2)
Patient Healthcare Utilization - Readmissions to the hospital at 6 Month Follow-up
Patient Healthcare Utilization will be measured with readmissions to the hospital
Measured: 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
Measured: 6 Month Follow-up after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start16 Sep 2021
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurdenStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christine Vinci, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078229
- Sponsor's protocol ID
- MCC-20786
- Other IDs
- R01CA255265
- Status last verified
- Jul 2026
- First submitted
- 2 Sep 2021
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35363799
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Mindfulness-Based Stress Management Program for Allogeneic HCT Caregivers
- ClinicalTrials.gov ID
- NCT05078229
- Acronym / sponsor ID
- MCC-20786
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to understand whether different stress management interventions impact stress among HCT cancer caregivers and patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FOCUS | Experimental | Behavioral: FOCUSFocusing 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. |
| Healthy Living | Active comparator | Behavioral: Healthy LivingHealthy 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. |
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOCUSThere 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. | Behavioural | FOCUS |
| Healthy LivingThere 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. | Behavioural | Healthy Living |
Primary outcome
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
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
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
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.
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
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.
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
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.
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
2 secondary outcomes
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 - unexpected clinic visits post discharge at 6 Month Follow-up
Time frame: 6 Month Follow-up after end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Derived from this study: PubMed 35363799Yang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Vinci, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOCUS and Healthy Living in people with Burden and Stress, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Burden at End of Treatment (time frame: Up to 8 Weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05078229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.