Trial Outcomes & Findings for Home or Away From Home - Descriptive Interviews (Aim 2) (NCT NCT02794207)

NCT ID: NCT02794207

Last Updated: 2020-01-27

Results Overview

Issues related to type of neutropenia management are not quantifiable. All interviewees gave unique responses to issues related to neutropenia management, and themes were identified after all interviews were conducted and analyzed.

Recruitment status

COMPLETED

Target enrollment

86 participants

Primary outcome timeframe

One qualitative semi-structured interview was conducted post-neutropenia management. The interview lasted about 30-45 minutes.

Results posted on

2020-01-27

Participant Flow

Participant milestones

Participant milestones
Measure
Participants
One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of the participant's illness and treatment. Several close-ended questions regarding participant's thoughts on potential outcomes will also be included.
Caregivers
One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of their child's illness and treatment. Several close-ended questions regarding participant's thoughts on their child's potential outcomes will also be included.
Overall Study
STARTED
32
54
Overall Study
COMPLETED
32
54
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Home or Away From Home - Descriptive Interviews (Aim 2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Patients
n=32 Participants
Patients who participated in a qualitative interview about their experience with AML. One qualitative, semi-structured interview was conducted. Each interview lasted approximately 30-45 minutes and may be audio recorded (if consent is provided).
Caregivers
Caregivers who participated in a qualitative interview about their experience with AML. One qualitative, semi-structured interview was conducted. Each interview lasted approximately 30-45 minutes and may be audio recorded (if consent is provided).
Total
n=32 Participants
Total of all reporting groups
Age, Categorical
<=18 years
23 Participants
n=5 Participants
23 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
n=5 Participants
9 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=5 Participants
Age, Continuous
14.4 years
STANDARD_DEVIATION 6.54 • n=5 Participants
14.4 years
STANDARD_DEVIATION 6.54 • n=5 Participants
Sex: Female, Male
Female
17 Participants
n=5 Participants
17 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
15 Participants
n=5 Participants
Region of Enrollment
United States
32 participants
n=5 Participants
32 participants
n=5 Participants

PRIMARY outcome

Timeframe: One qualitative semi-structured interview was conducted post-neutropenia management. The interview lasted about 30-45 minutes.

Population: All participants (patients and caregivers) who participated in the semi-structured interviews. 3 key, novel themes were identified across these interviews.

Issues related to type of neutropenia management are not quantifiable. All interviewees gave unique responses to issues related to neutropenia management, and themes were identified after all interviews were conducted and analyzed.

Outcome measures

Outcome measures
Measure
Participants
n=86 Participants
One qualitative, semi-structured interview will be conducted. Each interview lasted approximately 30-45 minutes and were audio recorded (if consent is provided). Interviews consisted of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of the participant's illness and treatment. Several close-ended questions regarding participant's thoughts on potential outcomes were also included.
Issues Related to Type of Neutropenia Management That Are Most Important to Children and Their Caregivers.
3 key themes identified

Adverse Events

Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Caregivers

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

Dr. Richard Aplenc

Children's Hospital of Philadelphia

Phone: 267-426-7252

Results disclosure agreements

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