Feasibility and Acceptability of A RN-Led Palliative and Supportive Care Intervention for Adults With Acute Leukemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- Retention Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
- •1. Patients receiving hospice care
- •[Caregiver]
- •Inclusion Criteria:
- •≧18 years of age
- •Identified by patient as caregiver
- •Speak and read English
Arms & Interventions
Control
Patients in the control arm will receive standard of care and no intervention.
Intervention
Patients in the intervention arm will receive the PACT intervention provided by a multidisciplinary team of RNs, OTs, and PTs.
Intervention: Palliative And supportive Care inTervention (PACT) (Other)
Outcomes
Primary Outcomes
Retention Rate
Time Frame: 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.
Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1.
Time Frame: 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 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.
Feasibility and Acceptability
Time Frame: Baseline
Feasibility and acceptability will be assessed as the number of participants who were approached, consented to, and eligible for the study.
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.
Time Frame: 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 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.
Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2.
Time Frame: 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 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.
Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time Frame: 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."
Symptom Monitoring Data Collection Rate
Time Frame: 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.
Caregiver Follow-Up Data Collection Rate
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported