N/A
N=67
RN-Led Palliative and Supportive Care Intervention
Acute Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT04570709 ↗Enrolled (actual)
67
Serious AEs
—
Results posted
Jun 2024
Primary outcome: Primary: Feasibility and Acceptability — 128; 93; 54; 38 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Palliative And supportive Care inTervention (PACT) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility and Acceptability |
128; 93; 54; 38 | — |
| PRIMARY Retention Rate |
20; 18; 20; 18; 15; 15 | — |
| PRIMARY Symptom Monitoring Data Collection Rate |
17; 12; 14; 10 | — |
| PRIMARY Caregiver Follow-Up Data Collection Rate |
10; 12 | — |
| PRIMARY Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1. |
55.8; 52.8; 72.3; 64.4; 83.3; 77.3 | — |
| PRIMARY Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2. |
64.4; 60.1; 76.9; 72.9; 86.7; 87.5 | — |
| PRIMARY 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. |
5.36; 3.81; 7.34; 4.76 | — |
| PRIMARY Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) |
9; 13; 12; 15; 7; 13 | — |
Summary
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.
Eligibility Criteria
[Patient]
Inclusion Criteria
- ≧60 years of age
- Diagnosis of acute myeloid leukemia
- Receive low-dose cytarabine or hypomethylating agent (HMA) in combination with Venetoclax chemotherapy
- Speak and read English
- Preference will be given to patients with care partners
Exclusion Criteria
- Patients receiving hospice care
[Caregiver]
Inclusion Criteria
- ≧18 years of age
- Identified by patient as caregiver
- Speak and read English
Data sourced from ClinicalTrials.gov (NCT04570709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.