RN-Led Palliative and Supportive Care Intervention

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.

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

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Other: Palliative And supportive Care inTervention (PACT)


Participation Criteria
=================
Eligibility 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 carepartners Exclusion Criteria: 1. Patients receiving hospice care [Caregiver] Inclusion Criteria: ≧18 years of age Identified by patient as caregiver Speak and read English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients in the control arm will receive standard of care and no intervention. | |
| Experimental: Intervention<br>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)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at the first and second cycle (baseline and about day 30) | 
| 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 the first and second cycle (baseline and about day 30) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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). | 
| 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 | 
| Steps as assessed by steps tracker | Steps per day | Throughout the study, around 6-9 months | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Symptoms, Function, Quality of life, Acute myeloid leukemia, Palliative care, Supportive care