RN-Led Palliative and Supportive Care Intervention

NCT ID: NCT04570709

Last Updated: 2024-09-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2024-06-06

Brief Summary

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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

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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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type EXPERIMENTAL

Palliative And supportive Care inTervention (PACT)

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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


1. ≧18 years of age
2. Identified by patient as caregiver
3. Speak and read English

Exclusion Criteria

1\. Patients receiving hospice care

\[Caregiver\]
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashley Bryant, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina Lineberger Comprehenisive Cancer Center

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5R34NR019131

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC1848

Identifier Type: -

Identifier Source: org_study_id

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