Clinical trial NCT00896792: Nurse Practitioner Hospice Program for Patients With Terminal Metastatic Cancer and Their Families or Caregivers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hematopoietic/Lymphoid Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
hematopoietic/lymphoid cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Increased length of enrollment time in hospice care
Secondary outcomes:
measure: Effects of incorporating a palliative care advanced registered nurse practitioner liaison program in the late-stage cancer care process
measure: Increased knowledge of hospice services as assessed by a knowledge survey
measure: Patient and family or caregiver psychological stress, as measured by the functional assessment of cancer therapy general (FACT-G) survey
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Jacksonville
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Gerardo Colon-Otero, M.D.
role: STUDY_CHAIR
References: