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RN-Led Palliative and Supportive Care Intervention

Primary Purpose

Acute Myeloid Leukemia

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Palliative And supportive Care inTervention (PACT)

About this trial

This is an interventional supportive care trial for Acute Myeloid Leukemia focused on measuring Symptoms, Function, Quality of life, Acute myeloid leukemia, Palliative care, Supportive care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

1. Patients receiving hospice care

[Caregiver]

Inclusion Criteria:

≧18 years of age
Identified by patient as caregiver
Speak and read English

Sites / Locations

University of North Carolina Lineberger Comprehenisive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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

Patients in the intervention arm will receive the PACT intervention provided by a multidisciplinary team of RNs, OTs, and PTs.

Outcomes

Primary Outcome Measures

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."

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.

Secondary Outcome Measures

Treatment-related symptoms as assessed by Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Quality of life as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

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.

Number of Falls

Self-report the number of falls

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.

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.

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.

Activities of daily living as assessed by Performance Assessment of Self-Care Skills (PASS)

Include medication management

Hand wash

Assess the independence, safety, and adequacy of washing hands

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

Functional as assessed by Karnofsky Performance Scale (KPS)

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)

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

Score ranges from 0-56. Lower score indicates higher fall risk.

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.

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.

Disease burden as assessed by the Functional Assessment of Cancer Therapy- leukemia subscale

Score ranges from 0-68. Higher score indicates lower symptom burden

Steps as assessed by steps tracker

Steps per day

Cognition abilities assessed by Clock Drawing assessment

Drawing the clock based on the instruction

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.

Occupational profile assessed by the Modified Canadian Occupational Performance Measure (Modified-COPM)

Average performance score and satisfaction score are calculated

Aerobic capacity and endurance assessed by 6 minute walk test

Record the distance walked for 6 minutes

Functional lower extremity strength assessed by the 30 second sit to stand test

Record the number of times the patient stands in 30 seconds

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

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

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.

Full Information

NCT ID

NCT04570709

First Posted

February 11, 2020

Last Updated

June 16, 2023

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Institute of Nursing Research (NINR)

1. Study Identification

Unique Protocol Identification Number

NCT04570709

Brief Title

RN-Led Palliative and Supportive Care Intervention

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 14, 2020 (Actual)

Primary Completion Date

October 20, 2025 (Anticipated)

Study Completion Date

October 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

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)

Allocation

Non-Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Patients in the intervention arm will receive the PACT intervention provided by a multidisciplinary team of RNs, OTs, and PTs.

Intervention Type

Other

Intervention Name(s)

Palliative And supportive Care inTervention (PACT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Treatment-related symptoms as assessed by Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Description

Time Frame

at the first and second cycle (baseline and about day 30)

Title

Quality of life as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

Description

Time Frame

at the first and second cycle (baseline and about day 30)

Secondary Outcome Measure Information:

Title

Treatment-related symptoms as assessed by Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Description

Time Frame

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

Title

Quality of life as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

Description

Time Frame

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

Title

Patients participation in meaningful activity as assessed by Possibilities for activity Scale (PACTS)

Description

Score ranges from 14-70. Higher score indicates higher perceived possibility to perform activity.

Time Frame

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

Title

Number of Falls

Description

Self-report the number of falls

Time Frame

Title

Patients' readiness of care transitions and discharge as assessed by Care Transitions Measure (CTM)

Description

Score ranges from 0-100. Higher score indicates better quality of transition.

Time Frame

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

Title

Patients activation toward health and care as assessed by Patient Activation Measure (PAM)

Description

Score ranges from 0-100. The recommended cut-off score will be used to interpret the meaning of the score.

Time Frame

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

Title

Function as assessed by Activity Measure in Post-Acute Care (AM-PAC)

Description

Guide discharge planning; guides resource utilization; provides insight; patient mobility. A standardized t-score will be generated.

Time Frame

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

Title

Activities of daily living as assessed by Performance Assessment of Self-Care Skills (PASS)

Description

Include medication management

Time Frame

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

Title

Hand wash

Description

Assess the independence, safety, and adequacy of washing hands

Time Frame

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

Title

Health care use

Description

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

Time Frame

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

Title

Functional as assessed by Karnofsky Performance Scale (KPS)

Description

Classify participants' functional impairment. Score ranges from 0-100. Higher score indicates better function level.

Time Frame

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

Title

Patient mobility, balance, and fall risk as assessed by Timed Up and Go (3 meter walk)

Description

Patient balance and fall risk will be observed during the assessment. Time in seconds will be recorded.

Time Frame

at first, second, and seventh cycle (baseline, about day 30 and 180). For intervention group, additional assessment at the fifth cycle (about day 120).

Title

Fall risk as assessed by BERG Balance Scale

Description

Score ranges from 0-56. Lower score indicates higher fall risk.

Time Frame

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.

Title

Hand grip strength as assessed by hand held dynamometry

Description

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.

Time Frame

Title

Caregivers' readiness of care transitions and discharge as assessed by Preparedness Caregiving Scale

Description

Score ranges from 0-32. Higher score indicates higher level of preparedness.

Time Frame

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.

Title

Disease burden as assessed by the Functional Assessment of Cancer Therapy- leukemia subscale

Description

Score ranges from 0-68. Higher score indicates lower symptom burden

Time Frame

Title

Steps as assessed by steps tracker

Description

Steps per day

Time Frame

Throughout the study, around 6-9 months

Title

Cognition abilities assessed by Clock Drawing assessment

Description

Drawing the clock based on the instruction

Time Frame

at first, second, and seventh cycles (baseline, about day 30 and 180). For intervention group, additional assessment at the fourth cycle (about day 90).

Title

Cognition function assessed by Montreal Cognitive Assessment (MoCA) version 8.1 English

Description

Score ranges from 0-30. Score of 26 or above is considered as normal cognition.

Time Frame

For intervention group only, at first, second, fourth, and seventh cycle (baseline, about day 30, 90, and 180) as needed

Title

Occupational profile assessed by the Modified Canadian Occupational Performance Measure (Modified-COPM)

Description

Average performance score and satisfaction score are calculated

Time Frame

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

Title

Aerobic capacity and endurance assessed by 6 minute walk test

Description

Record the distance walked for 6 minutes

Time Frame

For intervention group only, at first, second, fifth, and seventh cycle (baseline, about day 30, 120, and 180)

Title

Functional lower extremity strength assessed by the 30 second sit to stand test

Description

Record the number of times the patient stands in 30 seconds

Time Frame

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

Title

Caregiver's physical and mental health assessed by PROMIS 29+2

Description

Generate a standardized T-score. Higher score indicates worse health and higher symptom burden

Time Frame

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

Title

Caregiver's well-being assessed by the Positive Affect and Well-Being-short form

Description

Generate a standardized T-score. Higher score indicates better self-report well-being

Time Frame

Title

Cognitive function as assessed by Functional Assessment of Cancer Therapy - Cognitive Function

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ashley Bryant, PhD, RN

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina Lineberger Comprehenisive Cancer Center

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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