RN-Led Palliative and Supportive Care Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Other: Palliative And supportive Care inTervention (PACT)

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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Lineberger Comprehenisive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

[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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients in the control arm will receive standard of care and no intervention.
Experimental: Intervention; Patients in the intervention arm will receive the PACT intervention provided by a multidisciplinary team of RNs, OTs, and PTs.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)
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)
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
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
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)
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Steps as assessed by steps tracker	Steps per day	Throughout the study, around 6-9 months
Patient mobility, balance, and fall risk as assessed by Timed Up and Go (3 meter walk)	Patient balance and fall risk will be observed during the assessment. Time in seconds will be recorded.	at first, second, and seventh cycle (baseline, about day 30 and 180). For intervention group, additional assessment at the fifth cycle (about day 120).
Cognition abilities assessed by Clock Drawing assessment	Drawing the clock based on the instruction	at first, second, and seventh cycles (baseline, about day 30 and 180). For intervention group, additional assessment at the fourth cycle (about day 90).
Cognition function assessed by Montreal Cognitive Assessment (MoCA) version 8.1 English	Score ranges from 0-30. Score of 26 or above is considered as normal cognition.	For intervention group only, at first, second, fourth, and seventh cycle (baseline, about day 30, 90, and 180) as needed
Aerobic capacity and endurance assessed by 6 minute walk test	Record the distance walked for 6 minutes	For intervention group only, at first, second, fifth, and seventh cycle (baseline, about day 30, 120, and 180)
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."	daily between first and third cycle (about 60 days), at fourth, fifth, sixth, and seventh cycle (about day 90, 120, 150,180). For intervention group, weekly between third and seventh cycle and every 3 months until 5 years after end of intervention
Quality of life as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	Including five functional scales, three symptom scales, one global quality of life scale, and six symptom items. The score ranges from 0-100, higher score indicates better function and greater symptom burden.	at third, fourth, fifth, sixth, and seventh cycle (about day 30, 90, 120, 150, and 180). For intervention group, additional follow-ups every 3 months until 5 years after end of intervention
Patients participation in meaningful activity as assessed by Possibilities for activity Scale (PACTS)	Score ranges from 14-70. Higher score indicates higher perceived possibility to perform activity.	at first, second, third, fourth, fifth, sixth, and seventh cycle (baseline, about day 30, 60, 90, 120, 150, and 180). For intervention group, additional follow-ups every 3 months until 5 years after end of intervention
Number of Falls	Self-report the number of falls	at first, second, third, fourth, fifth, sixth, and seventh cycle (baseline, about day 30, 60, 90, 120, 150, and 180). For intervention group, additional follow-ups every 3 months until 5 years after end of intervention
Patients' readiness of care transitions and discharge as assessed by Care Transitions Measure (CTM)	Score ranges from 0-100. Higher score indicates better quality of transition.	completion of first, second, and seventh cycle (about day 7, 37, 187). For intervention group, additional follow-ups every 3 months until 5 years after end of intervention
Patients activation toward health and care as assessed by Patient Activation Measure (PAM)	Score ranges from 0-100. The recommended cut-off score will be used to interpret the meaning of the score.	completion of first, second, and seventh cycle (about day 7, 37, 187). For intervention group, additional follow-ups every 3 months until 5 years after end of intervention
Function as assessed by Activity Measure in Post-Acute Care (AM-PAC)	Guide discharge planning; guides resource utilization; provides insight; patient mobility. A standardized t-score will be generated.	at first, second, and seventh cycle (baseline, day 30 and 180). For intervention group, additional assessment at the fourth and fifth cycle (about day 90, 120), 3 months, 6 months, and every 6 months until 5 years after end of intervention
Activities of daily living as assessed by Performance Assessment of Self-Care Skills (PASS)	Include medication management	at first, second, and seventh cycle (baseline, about day 30 and 180). For intervention group, additional assessment at the fourth cycle (about day 90), 3 months, 6 months, and every 6 months until 5 years after end of intervention
Hand wash	Assess the independence, safety, and adequacy of washing hands	at the first, second, and seventh cycle (baseline, about day 30 and 180). For intervention group, additional assessment at the fourth cycle (about day 90), 3 months, 6 months, and every 6 months until 5 years after end of intervention
Health care use	Identify use or not use health care service, then report the use of health care service, the service type, the reason of using health care service using open ended questions	at second, third, fourth, fifth, sixth, and seventh cycle(about day 30, 60, 90, 120, 150, and 180). For intervention group, additional follow-ups every 3 months until 5 years after end of intervention
Functional as assessed by Karnofsky Performance Scale (KPS)	Classify participants' functional impairment. Score ranges from 0-100. Higher score indicates better function level.	at first, second, third, fourth, fifth, sixth, seventh cycle (baseline, about day 7, 30, 37, 60, 90, 120, 150, 180, and 187). For intervention group, additional follow-ups every 3 months until 5 years after end of intervention
Fall risk as assessed by BERG Balance Scale	Score ranges from 0-56. Lower score indicates higher fall risk.	at first, second, and seventh cycle (baseline, about day 30 and 180). For intervention group, additional assessment at the fifth cycle (about day 120), 3 months, 6 months, and every 6 months until 5 years after end of intervention.
Hand grip strength as assessed by hand held dynamometry	Three trials will be performed on both right and left hands at each assessment. Average grip strength will be generated. Dominant hand will be documented.	at first, second, and seventh cycle (baseline, about day 30 and 180). For intervention group, additional assessment at the fourth cycle (about day 90), 3 months, 6 months, and every 6 months until 5 years after end of intervention
Caregivers' readiness of care transitions and discharge as assessed by Preparedness Caregiving Scale	Score ranges from 0-32. Higher score indicates higher level of preparedness.	completion of first, second, and seventh cycle (about day 7, 37, 187). For intervention group, additional assessment at the third, fourth, fifth, and sixth cycle (about day 67, 97, 127, 157) and every 3 months until 5 years after end of intervention.
Disease burden as assessed by the Functional Assessment of Cancer Therapy- leukemia subscale	Score ranges from 0-68. Higher score indicates lower symptom burden	at first, second, third, fourth, fifth, sixth, and seventh cycle (baseline, about day 30, 60, 90, 120, 150, and 180). For intervention group, additional follow-ups every 3 months until 5 years after end of intervention
Occupational profile assessed by the Modified Canadian Occupational Performance Measure (Modified-COPM)	Average performance score and satisfaction score are calculated	For intervention group only, at first, second, fourth, and seventh cycle (baseline, about day 30, 90, and 180), 3 months, 6 months, and every 6 months until 5 years after end of intervention
Functional lower extremity strength assessed by the 30 second sit to stand test	Record the number of times the patient stands in 30 seconds	For intervention group only, at first, second, fifth, and seventh cycle (baseline, about day 30, 120, and 180), 3 months, 6 months, and every 6 months until 5 years after end of intervention
Caregiver's physical and mental health assessed by PROMIS 29+2	Generate a standardized T-score. Higher score indicates worse health and higher symptom burden	For intervention group only, completion of first, second, third, fourth, fifth, sixth, and seventh cycle (about day 7, 37, 67, 97, 127, 157, and 187), every 3 months follow-ups until 5 years after end of intervention
Caregiver's well-being assessed by the Positive Affect and Well-Being-short form	Generate a standardized T-score. Higher score indicates better self-report well-being	For intervention group only, completion of first, second, third, fourth, fifth, sixth, and seventh cycle (about day 7, 37, 67, 97, 127, 157, and 187), every 3 months follow-ups until 5 years after end of intervention
Cognitive function as assessed by Functional Assessment of Cancer Therapy - Cognitive Function	The questionnaire consists of 4 domains, including perceived cognitive impairments, comments from others, perceived cognitive abilities, and impact of quality of life. The higher the score, the better the cognitive function.	For intervention group only: at first, second, third, fourth, fifth, sixth, and seventh cycle (baseline, about day 30, 60, 90, 120, 150, and 180), every 3 months follow-ups until 5 years after end of intervention

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Ashley Bryant, PhD, RN, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): April 4, 2023
• Study Completion (Actual): June 6, 2024

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 10, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Palliative care; Function; Acute myeloid leukemia; Symptoms; Supportive care
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: LCCC1848; 5R34NR019131 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No