Nurse Practitioner Hospice Program for Patients With Terminal Metastatic Cancer and Their Families or Caregivers

The Pilot Palliative ARNP (Advanced Registered Nurse Practitioner) Liaison Program (The PAL Program): Improving Communication Between Patients, Oncologists, and Hospice, Promoting Timely Hospice Referrals and Bringing Education and Research Efforts to Hospice and Palliative Care

RATIONALE: Gathering information about patients with terminal metastatic cancer may help doctors learn more about the effectiveness of a nurse practitioner hospice program. It is not yet known whether a nurse practitioner program helps increase patients' length of stay in hospice.

PURPOSE: This randomized research study is evaluating a nurse practitioner hospice program for patients with terminal metastatic cancer and their families or caregivers.

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Hematopoietic/Lymphoid Cancer
• Intervention / Treatment: Other: survey administration; Other: questionnaire administration; Procedure: psychosocial assessment and care; Other: counseling intervention; Procedure: end-of-life treatment/management

Detailed Description

OBJECTIVES:

Primary

• To assess the effect of the palliative advanced registered nurse practitioner liaison program (PAL) on length of patient's enrollment in hospice care.

Secondary

• To evaluate the impact of the PAL program on patient's knowledge about hospice services.
• To evaluate the impact of the PAL program on patient and family or caregiver's psychological stress during palliative treatments.

OUTLINE: Patients are randomized to 1 of 2 arms.

• Arm I (advanced registered nurse practitioner [ARNP] intervention): Patients and their families or caregiver receive information from an ARNP about terminal cancer, resources available for supportive care, and the benefits of palliative care. After transition to hospice, patients receive pain and palliative medicine, psychology, social services, chaplaincy, and patient support group intervention arranged by the ARNP. Patients complete the Patient Questionnaire about overall quality of life and mental, emotional, and physical well being at baseline and at 3 weeks after intervention or at time of enrollment in hospice. Patients and their families or caregivers are contacted by the ARNP weekly.
• Arm II (no ARNP intervention): Patients and their families or caregivers complete the same Patient Questionnaire, administered by a clinical research assistant (CRA), as in Arm I. Patients and their families or caregivers receive no ARNP intervention. After transition to hospice, patients receive routine hospice care.

Patients participate in this study for a duration of 21 days while in hospice care. At the completion of the study, patients in both arms complete questionnaires about pain management, social, emotional, and spiritual and mental well-being. Patients' families or caregivers complete the Caregiver Questionnaire and the Hospice Family Satisfaction Survey 3 weeks after patient's death.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Jacksonville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Diagnosis of terminal metastatic cancer
• Patient at Mayo Clinic in Jacksonville, Florida
• Strong candidate for hospice care

• Entering or planning to enter Community Hospice of Northeast Florida

  • Willing to undergo visits by an Advanced Registered Nurse Practitioner (ARNP) after hospice enrollment

PATIENT CHARACTERISTICS:

• Willing to participate in 2 palliative care consultations with an ARNP prior to hospice enrollment
• Life expectancy < 12 months
• Able to complete questionnaires with or without assistance
• Has a primary caregiver with an identified relationship to the patient

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Increased length of enrollment time in hospice care

Secondary Outcome Measures

Outcome Measure
Effects of incorporating a palliative care advanced registered nurse practitioner liaison program in the late-stage cancer care process
Increased knowledge of hospice services as assessed by a knowledge survey
Patient and family or caregiver psychological stress, as measured by the functional assessment of cancer therapy general (FACT-G) survey

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Gerardo Colon-Otero, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2008
• Primary Completion (Actual): November 20, 2009
• Study Completion (Actual): March 17, 2015

Study Registration Dates

• First Submitted: May 9, 2009
• First Submitted That Met QC Criteria: May 9, 2009
• First Posted (Estimate): May 12, 2009

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific; hematopoietic/lymphoid cancer
• Other Study ID Numbers: CDR0000615562; P30CA015083 (U.S. NIH Grant/Contract); MC0892 (Other Identifier: Mayo Clinic Cancer Center); 08-002293 (Other Identifier: Mayo Clinic IRB)