RN-Led Palliative and Supportive Care Intervention

Sponsor

UNC Lineberger Comprehensive Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04570709

Collaborator

(none)

Enrollment

Location

Arms

23.6

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Other: Palliative And supportive Care inTervention (PACT)	N/A

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

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 14, 2020

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Treatment-related symptoms as assessed by Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [at the third cycle of treatment (about day 60)]
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."
Quality of life as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [at the third cycle of treatment (about day 60)]
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.

Secondary Outcome Measures

Treatment-related symptoms as assessed by Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [prior to treatment (baseline), daily between first and third cycle of treatment (about 60 days), at fourth, fifth, sixth, and seventh cycles of treatment (about day 90, 120, 150,180). For intervention group, weekly assessment from third to seventh cycle.]
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."
Quality of life as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [at the first, second, fourth, fifth, sixth, and seventh cycles of treatment (baseline, about day 30, 90, 120, 150, and 180)]
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.
Patients participation in meaningful activity as assessed by Possibilities for activity Scale (PACTS) [at the first, second, third, fourth, fifth, sixth, and seventh cycles of treatment (baseline, about day 30, 60, 90, 120, 150, and 180)]
Score ranges from 14-70. Higher score indicates higher perceived possibility to perform activity.
Number of Falls [at the first, second, third, fourth, fifth, sixth, and seventh cycles of treatment (baseline, about day 30, 60, 90, 120, 150, and 180)]
Self-report the number of falls
Patients' readiness of care transitions and discharge as assessed by Care Transitions Measure (CTM) [completion of first, second, and seventh cycle of HMA or low-dose cytarabine infusion (about day 7, about day 37, about day 187)]
Score ranges from 0-100. Higher score indicates better quality of transition.
Patients activation toward health and care as assessed by Patient Activation Measure (PAM) [completion of first, second, and seventh cycle of HMA or low-dose cytarabine infusion (about day 7, about day 37, about day 187)]
Score ranges from 0-100. The recommended cut-off score will be used to interpret the meaning of the score.
Function as assessed by Activity Measure in Post-Acute Care (AM-PAC) [at the first, second, and seventh cycles of treatment (baseline, day 30 and 180). For intervention group, additional assessment at the fourth and fifth cycles of treatment (about day 90, 120).]
Guide discharge planning; guides resource utilization; provides insight; patient mobility. A standardized t-score will be generated.
Activities of daily living as assessed by Performance Assessment of Self-Care Skills (PASS) [at the first, second, and seventh cycles of treatment (baseline, about day 30 and 180). For intervention group, additional assessment at the fourth cycle of treatment (about day 90).]
Include medication management
Hand wash [at the first, second, and seventh cycles of treatment (baseline, about day 30 and 180). For intervention group, additional assessment at the fourth cycle of treatment (about day 90).]
Assess the independence, safety, and adequacy of washing hands
Health care use [at the second, third, fourth, fifth, sixth, and seventh cycles of treatment (about day 30, 60, 90, 120, 150, and 180)]
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
Functional as assessed by Karnofsky Performance Scale (KPS) [at the first, second, third, fourth, fifth, sixth, and seventh cycles of treatment (baseline, about day 30, 60, 90, 120, 150, and 180), completion of first, second, and seventh cycles of HMA or low-dose cytarabine infusion (about day 7, 37, and 187)]
Classify participants' functional impairment. Score ranges from 0-100. Higher score indicates better function level.
Patient mobility, balance, and fall risk as assessed by Timed Up and Go (3 meter walk) [at the first, second, and seventh cycles of treatment (baseline, about day 30 and 180). For intervention group, additional assessment at the fifth cycle of treatment (about day 120).]
Patient balance and fall risk will be observed during the assessment. Time in seconds will be recorded.
Fall risk as assessed by BERG Balance Scale [at the first, second, and seventh cycles of treatment (baseline, about day 30 and 180). For intervention group, additional assessment at the fifth cycle of treatment (about day 120).]
Score ranges from 0-56. Lower score indicates higher fall risk.
Hand grip strength as assessed by hand held dynamometry [at the first, second, and seventh cycles of treatment (baseline, about day 30 and 180). For intervention group, additional assessment at the fourth cycle of treatment (about day 90).]
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.
Caregivers' readiness of care transitions and discharge as assessed by Preparedness Caregiving Scale [completion of first, second, and seventh cycles of HMA or low-dose cytarabine (about day 7, 37, 187). For intervention group, additional assessment at the third, fourth, fifth, and sixth cycle of infusion (about day 67, 97, 127, 157).]
Score ranges from 0-32. Higher score indicates higher level of preparedness.
Disease burden as assessed by the Functional Assessment of Cancer Therapy- leukemia subscale [at the first, second, third, fourth, fifth, sixth, and seventh cycles of treatment (baseline, about day 30, 60, 90, 120, 150, and 180)]
Score ranges from 0-68. Higher score indicates lower symptom burden
Steps as assessed by steps tracker [Throughout the study, around 6-9 months]
Steps per day
Cognition abilities assessed by Clock Drawing assessment [at the first, second, and seventh cycles of treatment (baseline, about day 30 and 180). For intervention group, additional assessment at the fourth cycle of treatment (about day 90).]
Drawing the clock based on the instruction
Cognition function assessed by Montreal Cognitive Assessment (MoCA) version 8.1 English [For intervention group only, at the first, second, fourth, and seventh cycles of treatment (baseline, about day 30, 90, and 180)]
Score ranges from 0-30. Score of 26 or above is considered as normal cognition.
Occupational profile assessed by the Modified Canadian Occupational Performance Measure (Modified-COPM) [For intervention group only, at the first, second, fourth, and seventh cycles of treatment (baseline, about day 30, 90, and 180)]
Average performance score and satisfaction score are calculated
Aerobic capacity and endurance assessed by 6 minute walk test [For intervention group only, at the first, second, fifth, and seventh cycles of treatment (baseline, about day 30, 120, and 180)]
Record the distance walked for 6 minutes
Functional lower extremity strength assessed by the 30 second sit to stand test [For intervention group only, at the first, second, fifth, and seventh cycles of treatment (baseline, about day 30, 120, and 180)]
Record the number of times the patient stands in 30 seconds
Caregiver's physical and mental health assessed by PROMIS 29+2 [For intervention group only, completion of first, second, third, fourth, fifth, sixth, and seventh cycles of HMA or low-dose cytarabine infusion (about day 7, 37, 67, 97, 127, 157, and 187)]
Generate a standardized T-score. Higher score indicates worse health and higher symptom burden
Caregiver's well-being assessed by the Positive Affect and Well-Being-short form [For intervention group only, completion of first, second, third, fourth, fifth, sixth, and seventh cycles of HMA or low-dose cytarabine infusion (about day 7, 37, 67, 97, 127, 157, and 187)]
Generate a standardized T-score. Higher score indicates better self-report well-being
Cognitive function as assessed by Functional Assessment of Cancer Therapy - Cognitive Function [For intervention group only: at the first, second, third, fourth, fifth, sixth, and seventh cycle of treatment (baseline, about day 30, 60, 90, 120, 150, and 180)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

[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