NCT00896792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Oct 2008

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2009

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2015

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

1.1 years

First QC Date

May 9, 2009

Last Update Submit

October 4, 2018

Conditions

Keywords

unspecified adult solid tumor, protocol specifichematopoietic/lymphoid cancer

Outcome Measures

Primary Outcomes (1)

  • Increased length of enrollment time in hospice care

Secondary Outcomes (3)

  • Effects of incorporating a palliative care advanced registered nurse practitioner liaison program in the late-stage cancer care process

  • Increased knowledge of hospice services as assessed by a knowledge survey

  • Patient and family or caregiver psychological stress, as measured by the functional assessment of cancer therapy general (FACT-G) survey

Interventions

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Jacksonville

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

CounselingTherapeuticsPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesRehabilitation

Study Officials

  • Gerardo Colon-Otero, M.D.

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

October 10, 2008

Primary Completion

November 20, 2009

Study Completion

March 17, 2015

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations