Clinical trial NCT04570709: RN-Led Palliative and Supportive Care Intervention
Official title: Feasibility and Acceptability of A RN-Led Palliative and Supportive Care Intervention for Adults With Acute Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: Symptoms
Function
Quality of life
Acute myeloid leukemia
Palliative care
Supportive care
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-09-30
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is a feasibility study. This study is conducted on one unit and to reduce bias and contamination, the control patients will be recruited and consented first. After recruitment of the 20 control patients, we will then recruit 20 intervention patients.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: The primary objective of the study is to assess feasibility, acceptability, and change in pre and post measures of symptoms, function, and QOL by administering the PACT intervention. The first 20 participants in the control group will receive usual care. The next 20 participants will receive the PACT intervention. Each participant in the intervention group will be cared by a collaborative, multidisciplinary, integrated team including RNs, OTs and PTs.

Eligibility criteria: \[Patient\]

Inclusion Criteria:

1. ≧60 years of age
2. Diagnosis of acute myeloid leukemia
3. Receive low-dose cytarabine or hypomethylating agent (HMA) in combination with Venetoclax chemotherapy
4. Speak and read English
5. Preference will be given to patients with care partners

Exclusion Criteria:

1. Patients receiving hospice care

\[Caregiver\]

Inclusion Criteria:

1. ≧18 years of age
2. Identified by patient as caregiver
3. Speak and read English

Primary outcomes:
measure: Feasibility and Acceptability
timeFrame: Baseline
measure: Retention Rate
timeFrame: Baseline and up to 30 days (first and second cycles)
measure: Symptom Monitoring Data Collection Rate
timeFrame: Baseline and up to 30 days (first and second cycles)
measure: Caregiver Follow-Up Data Collection Rate
timeFrame: At second cycle (at days 30)
measure: Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1.
timeFrame: Baseline, up to 30 days
measure: Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2.
timeFrame: 30 days after starting to the study
measure: 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.
timeFrame: Baseline and until day 30 (Cycle 1 and Cycle 2)
measure: Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Up to180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Lineberger Comprehenisive Cancer Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ashley Bryant, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: