18 and older, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Feasibility and AcceptabilityPrimary· Baseline
Feasibility and acceptability will be assessed as the number of participants who were approached, consented to, and eligible for the study.
Screened
Group
Value
95% CI
Potential - Eligible- Consented Participants
128
Eligible
Group
Value
95% CI
Potential - Eligible- Consented Participants
93
Approached
Group
Value
95% CI
Potential - Eligible- Consented Participants
54
Consented
Group
Value
95% CI
Potential - Eligible- Consented Participants
38
Retention RatePrimary· Baseline and up to 30 days (first and second cycles)
The rate of participants who consented to the study completed study intervention at the time point.
Consented
Group
Value
95% CI
Control
20
Intervention
18
Cycle 1
Group
Value
95% CI
Control
20
Intervention
18
Cycle 2
Group
Value
95% CI
Control
15
Intervention
15
Symptom Monitoring Data Collection RatePrimary· Baseline and up to 30 days (first and second cycles)
The number of participants who joined the study and symptom monitoring were assessed at the time point.
Cycle 1
Group
Value
95% CI
Control
17
Intervention
12
Cycle 2
Group
Value
95% CI
Control
14
Intervention
10
Caregiver Follow-Up Data Collection RatePrimary· At second cycle (at days 30)
Caregiver Follow-Up data collection rate was assessed the number of caregiver participants who joined the study and symptom monitoring was assessed at the time points.
Group
Value
95% CI
Care Partner -Control
10
Care Partner- Interventional
12
Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1.Primary· Baseline, up to 30 days
Mean Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in control and intervention arms at Cycle 1.
The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and a global health and quali
Cycle1 Overall QoL
Group
Value
95% CI
Control
55.8
± 22.6
Intervention
52.8
± 25.7
Cycle1 Physical QoL
Group
Value
95% CI
Control
72.3
± 22.6
Intervention
64.4
± 27.7
Cycle1 Emotional QoL
Group
Value
95% CI
Control
83.3
± 15.3
Intervention
77.3
± 22.3
Cycle1 Fatigue
Group
Value
95% CI
Control
49.4
± 29.8
Intervention
53.1
± 30.1
Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2.Primary· 30 days after starting to the study
Mean Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in control and intervention arms at Cycle 2.
The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and a global health and quali
Cycle2 Overall QoL
Group
Value
95% CI
Control
64.4
± 16.8
Intervention
60.1
± 20.5
Cycle2 Physical QoL
Group
Value
95% CI
Control
76.9
± 18.0
Intervention
72.9
± 19.8
Cycle2 Emotional QoL
Group
Value
95% CI
Control
86.7
± 10.8
Intervention
87.5
± 15.6
Cycle2 Fatigue
Group
Value
95% CI
Control
39.3
± 17.2
Intervention
54.0
± 30.5
Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores Between Cycle 1 and Cycle 2.Primary· Baseline and until day 30 (Cycle 1 and Cycle 2)
Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in the intervention arm both at Cycle 1 and 2. Score difference for each subject and mean differences between scores were calculated.
The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better le
Overall QOL
Group
Value
95% CI
Intervention Group
5.36
± 26.27
Physical QOL
Group
Value
95% CI
Intervention Group
3.81
± 24.35
Emotional QOL
Group
Value
95% CI
Intervention Group
7.34
± 13.66
Fatigue
Group
Value
95% CI
Intervention Group
4.76
± 33.39
Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)Primary· Up to180 days
19 items include diarrhea, chills, heartburn, nausea, appetite, mouth sores, vomiting, constipation, cough, rash, shortness of breath, fatigue, anxiety, sadness, nothing will cheer me up, pain, insomnia, concentration, and memory. The severity is assessed from "None" to "Very severe" and the interference level is assessed from "Not at all" to "Very much."
diarrhea
Group
Value
95% CI
Control
9
Intervention
13
chills
Group
Value
95% CI
Control
12
Intervention
15
heartburn
Group
Value
95% CI
Control
7
Intervention
13
nausea
Group
Value
95% CI
Control
8
Intervention
14
appetite
Group
Value
95% CI
Control
11
Intervention
15
mouth sores
Group
Value
95% CI
Control
8
Intervention
15
vomiting
Group
Value
95% CI
Control
1
Intervention
9
constipation
Group
Value
95% CI
Control
10
Intervention
15
Sponsor's own description
This single institution feasibility and acceptability study includes patients with acute leukemia which is designed to examine a novel palliative and supportive care intervention (Palliative and supportive Care inTervention; PACT) in which registered nurses (RNs), occupational therapists (OTs), and physical therapists (PTs) address the activity needs of older adults with acute leukemia during their hospital stay.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center
Last refreshed: 25 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04570709.