RN-Led Palliative and Supportive Care Intervention

Acute Myeloid Leukemia Clinical Trial

Official title:

Feasibility and Acceptability of A RN-Led Palliative and Supportive Care Intervention for Adults With Acute Leukemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04570709
• Other study ID #: LCCC1848
• Secondary ID: 5R34NR019131
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: April 4, 2028

Study information

• Verified date: June 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 67
• Est. completion date: April 4, 2028
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

[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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• Palliative And supportive Care inTervention (PACT)
Using the Adaptive Leadership Framework for Chronic Illness as a guide. The nurse, occupational and physical therapists will meet with the patient and caregiver after the baseline assessment to discuss their Specific, Measurable, Achievable, Relevant, and Time-Bound (SMART) goals. Additionally, the occupational and physical therapists will provide the patient a PACT intervention binder. Regular phone calls or visits from a registered nurse, occupational therapists, and physical therapists for patients and caregivers in the intervention.

Locations

Country	Name	City	State
United States	University of North Carolina Lineberger Comprehenisive Cancer Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and Acceptability	Feasibility and acceptability will be assessed as the number of participants who were approached, consented to, and eligible for the study.	Baseline
Primary	Retention Rate	The rate of participants who consented to the study completed study intervention at the time point.	Baseline and up to 30 days (first and second cycles)
Primary	Symptom Monitoring Data Collection Rate	The number of participants who joined the study and symptom monitoring were assessed at the time point.	Baseline and up to 30 days (first and second cycles)
Primary	Caregiver Follow-Up Data Collection Rate	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.	At second cycle (at days 30)
Primary	Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1.	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 quality-of-life scale. 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 level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale.	Baseline, up to 30 days
Primary	Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2.	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 quality-of-life scale. 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 level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale.	30 days after starting to the study
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.	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 level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale.	Baseline and until day 30 (Cycle 1 and Cycle 2)
Primary	Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	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."	Up to180 days