Nurse Practitioner Hospice Program for Patients With Terminal Metastatic Cancer and Their Families or Caregivers
NCT ID: NCT00896792
Last Updated: 2018-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
26 participants
INTERVENTIONAL
2008-10-10
2015-03-17
Brief Summary
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PURPOSE: This randomized research study is evaluating a nurse practitioner hospice program for patients with terminal metastatic cancer and their families or caregivers.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
Interventions
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counseling intervention
questionnaire administration
survey administration
end-of-life treatment/management
psychosocial assessment and care
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Gerardo Colon-Otero, M.D.
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Mayo Clinic in Jacksonville
Jacksonville, Florida, United States
Countries
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Other Identifiers
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MC0892
Identifier Type: OTHER
Identifier Source: secondary_id
08-002293
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000615562
Identifier Type: -
Identifier Source: org_study_id
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