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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00896792
Recruitment Status : Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : November 17, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Hematopoietic/Lymphoid Cancer Unspecified Adult Solid Tumor, Protocol Specific Other: counseling intervention Other: questionnaire administration Other: survey administration Procedure: end-of-life treatment/management Procedure: psychosocial assessment and care Not Applicable

Detailed Description:



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


  • 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  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Primary Purpose: Other
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
Actual Study Start Date : October 2008
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Increased length of enrollment time in hospice care

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00896792

United States, Florida
Mayo Clinic in Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Gerardo Colon-Otero, M.D. Mayo Clinic

Responsible Party: Mayo Clinic Identifier: NCT00896792     History of Changes
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 )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: May 2017

Keywords provided by Mayo Clinic:
unspecified adult solid tumor, protocol specific
hematopoietic/lymphoid cancer