RN-Led Palliative and Supportive Care Intervention

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Acute Myeloid Leukemia

Treatments: Other: Palliative And supportive Care inTervention (PACT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04570709

LCCC1848

5R34NR019131 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

[Patient]

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

Exclusion Criteria:

1. Patients receiving hospice care

[Caregiver]

Inclusion Criteria:

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Control

No Intervention group

Description:

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

Intervention

Experimental group

Description:

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

Treatment:

Other: Palliative And supportive Care inTervention (PACT)