Nurse Practitioner Hospice Program for Patients With Terminal Metastatic Cancer and Their Families or Caregivers
This study is ongoing, but not recruiting participants.
Sponsor:
Mayo Clinic
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00896792
First received: May 9, 2009
Last updated: May 22, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Increased length of enrollment time in hospice care [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Gerardo Colon-Otero, M.D., Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00896792 History of Changes |
| Other Study ID Numbers: | CDR0000615562, P30CA015083, MC0892, 08-002293 |
| Study First Received: | May 9, 2009 |
| Last Updated: | May 22, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Mayo Clinic:
|
unspecified adult solid tumor, protocol specific hematopoietic/lymphoid cancer |
ClinicalTrials.gov processed this record on May 21, 2013