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

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

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 year

qualitative data to develop and refine the caregiver intervention

Outcome measures

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

Areej El-Jawahri

Massachusetts General Hospital

Phone: 617-724-4000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place