Burden, Stress
Conditions
Brief summary
The purpose of the study is to understand whether different stress management interventions impact stress among HCT cancer caregivers and patients.
Interventions
BEHAVIORALFOCUS
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.
BEHAVIORALHealthy 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.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
| 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 |
| 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. |
| 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 |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristine Vinci, PhD
Moffitt Cancer Center
Outcome results
None listed