RN-Led Palliative and Supportive Care Intervention

NCT04570709 | Completed Results DMC

• 2 other identifiers: LCCC18485R34NR019131
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

Symptoms; Function; Quality of life; Acute myeloid leukemia; Palliative care; Supportive care

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Control

NO INTERVENTION

Patients in the control arm will receive standard of care and no intervention.

Intervention

EXPERIMENTAL

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)

Interventions

Palliative And supportive Care inTervention (PACT) OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≧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

You may not qualify if:

• \. Patients receiving hospice care
• \[Caregiver\]
• ≧18 years of age
• Identified by patient as caregiver
• Speak and read English

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of North Carolina Lineberger Comprehenisive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Melahat Canter
• Organization: University of North Carolina Lineberger Comprehensive Cancer Center

Melahat_Canter@med.unc.edu

9199620000

Study Officials

• Ashley Bryant, PhD, RN

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: September 30, 2020
• Study Start: September 14, 2020
• Primary Completion: April 4, 2023
• Study Completion: June 6, 2024
• Last Updated: September 25, 2024
• Results First Posted: June 11, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)