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

Early Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Hematopoietic/Lymphoid Cancer

• Registration Number: NCT00896792
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2008-10-10
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2009-11-20
• Study Completion: 2015-03-17
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-04
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Increased length of enrollment time in hospice care

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Jacksonville; 🇺🇸 Jacksonville, Florida, United States