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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00896792
First received: May 9, 2009
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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 Intervention
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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Increased length of enrollment time in hospice care [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects of incorporating a palliative care advanced registered nurse practitioner liaison program in the late-stage cancer care process [ Designated as safety issue: No ]
  • Increased knowledge of hospice services as assessed by a knowledge survey [ Designated as safety issue: No ]
  • Patient and family or caregiver psychological stress, as measured by the functional assessment of cancer therapy general (FACT-G) survey [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2008
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896792

Locations
United States, Florida
Mayo Clinic in Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Gerardo Colon-Otero, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Gerardo Colon-Otero, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00896792     History of Changes
Other Study ID Numbers: CDR0000615562, P30CA015083, MC0892, 08-002293
Study First Received: May 9, 2009
Last Updated: March 24, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 21, 2014