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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896792
• Other study ID #: CDR0000615562
• Secondary ID: P30CA015083MC089
• Status: Completed
• Phase: Early Phase 1
• Start date: October 10, 2008
• Est. completion date: March 17, 2015

Study information

• Verified date: October 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 17, 2015
• Est. primary completion date: November 20, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic/Lymphoid Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• counseling intervention

• questionnaire administration

• survey administration

Procedure:
• end-of-life treatment/management

• psychosocial assessment and care

Locations

Country	Name	City	State
United States	Mayo Clinic in Jacksonville	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased length of enrollment time in hospice care
Secondary	Effects of incorporating a palliative care advanced registered nurse practitioner liaison program in the late-stage cancer care process
Secondary	Increased knowledge of hospice services as assessed by a knowledge survey
Secondary	Patient and family or caregiver psychological stress, as measured by the functional assessment of cancer therapy general (FACT-G) survey