Hematopoietic Cell Transplant
Conditions
Brief summary
The purpose of this research is to determine if it is possible to perform group drumming as an intervention during HCT, to begin to understand how interactive group drumming during HCT treatment affects patients' well-being (good and bad) during the treatment course and in the first four weeks after completion of the drumming sessions.
Detailed description
The purpose of this research is to determine if it is possible to perform group drumming as an intervention during HCT, to begin to understand how interactive group drumming during HCT treatment affects patients' well-being (good and bad) during the treatment course and in the first four weeks after completion of the drumming sessions.
Interventions
BEHAVIORALinteractive group drumming sessions
interactive group drumming sessions
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
interactive group drumming sessions
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* People who are at least 18 years old and are scheduled for HCT * Individuals must be able to understand and willing to sign a written informed consent form
Exclusion criteria
* People who are too ill to participate, i.e., while they are in contact isolation or have low platelets (less than 20,000/mcl) will not participate until their condition has improved. * Patients receiving outpatient HCT except patients with multiple myeloma. Patients with multiple myeloma may participate in the study even though they tend to spend nights away from the hospital.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of participation | Up to 1 week after hematopoietic cell transplant (HCT) | Defined as the number of subjects willing to participate in the interactive group drumming (IGD) divided by the number approached and asked to participate. These rates will be reported, along with the corresponding 95% confidence interval. |
| Rate of completion | Up to 1 week after HCT | Defined as the ratio of (the number of individuals who successfully complete the study \[4 sessions of IGD (about 20 minutes \[min.\] each)\], with two pre-and post- surveys \[8 minutes total, and two questionnaires (10 minutes total) about 160 minutes total time\]) relative to the number of individuals who consent to the study (the number from the numerator of the first ratio \[participation\]). These rates will be reported, along with the corresponding 95% confidence interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gather patient-reported information to study whether the effect of interactive group drumming (IGD) on targeted variables is more pronounced in successive sessions | Baseline up to 4 weeks after completion of IGD | Targeted variables defined as anxiety, energy mood, distress, relaxation, pain, and patient satisfaction. Will compare for each participant. The mean and standard deviation for each of these measures will be calculated. |
| Effect of support care provider (SCP) presence for each participant and among participants | Up to 4 weeks after completion of IGD | Will use a non-parametric test to compare difference in item scores with and without SCP presence. |
| Gather patient-reported data to suggest how participants respond to interactive group drumming (IGD) | Baseline up to 4 weeks after completion of IGD | Will be assessed by STADID Short Form Y-1. The after-IGD session measure will include a patient satisfaction item as well. The mean and standard deviation for each of these measures will be calculated. |
| Gather patient-reported information to suggest the optimal number of interactive group drumming (IGD) sessions | Baseline up to 4 weeks after completion of IGD | Will be assessed by STADID Short Form Y-1. The after-IGD session measure will include a patient satisfaction item as well. The mean and standard deviation for each of these measures will be calculated |
| Change in physiological response to interactive group drumming (IGD) | Baseline up to 1 week after HCT | Will be calculated at three time points during the session; repeated measures analysis of variance will be used to detect changes over the 3 readings. |
| Determine optimum length of session | Up to 4 weeks after completion of IGD | Will be assessed by comparing actual length of session reported on facilitator post-session observation forms with participant satisfaction as reported in post-session. The mean and standard deviation for each of these measures will be calculated. |
Countries
United States
Outcome results
None listed