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

May 9, 2009
March 24, 2014
October 2008
September 2014   (final data collection date for primary outcome measure)
Increased length of enrollment time in hospice care [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00896792 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Not Provided
  • 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 Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
Not Provided
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00896792
CDR0000615562, P30CA015083, MC0892, 08-002293
Yes
Gerardo Colon-Otero, M.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Gerardo Colon-Otero, M.D. Mayo Clinic
Mayo Clinic
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP