Skip to main content
OpenTrials
Completed

NCT Number: NCT00896792

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic in Jacksonville

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

counseling intervention

Other

Questionnaire Administration

Other

Survey Administration

Other

end-of-life treatment/management

Procedure

psychosocial assessment and care

Procedure

Primary outcomes

  1. Increased length of enrollment time in hospice care

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2015
First posted
May 12, 2009
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.