Trial Outcomes & Findings for Psychological Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT) (NCT NCT03042715)
NCT ID: NCT03042715
Last Updated: 2021-09-01
Results Overview
qualitative data to develop and refine the caregiver intervention
Recruitment status
COMPLETED
Target enrollment
6 participants
Primary outcome timeframe
1 year
Results posted on
2021-09-01
Participant Flow
Participant milestones
| Measure |
Qualitative Refinement
this clinical trials.gov report is focused on the qualitative refinement phase of the project.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psychological Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)
Baseline characteristics by cohort
| Measure |
Psychological Intervention Refinement
n=6 Participants
* Eight weekly sessions in-person or via telephone
* Qualitative interviews
* Feedback from 5-10 caregivers to refine the intervention.
Qualitative Interviews: phase 1 of the study entail refining the psychological intervention based on caregivers' feedback
|
|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 6 • n=93 Participants
|
|
Sex/Gender, Customized
female
|
4 Participants
n=93 Participants
|
|
Sex/Gender, Customized
male
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 1 yearqualitative data to develop and refine the caregiver intervention
Outcome measures
| Measure |
Qualitative Refinement
n=6 Participants
pilot qualitative refinement of intervention
|
|---|---|
|
Pilot Qualitative Refinement of the Caregiver Intervention
intervention length is feasible
|
5 Participants
|
|
Pilot Qualitative Refinement of the Caregiver Intervention
session length is appropriate
|
5 Participants
|
|
Pilot Qualitative Refinement of the Caregiver Intervention
preferred fewer visits
|
3 Participants
|
|
Pilot Qualitative Refinement of the Caregiver Intervention
focus on mindfulness is appropriate
|
5 Participants
|
Adverse Events
Qualitative Refinement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place