Nurse Practitioner Hospice Program for Patients With Terminal Metastatic Cancer and Their Families or Caregivers
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|ClinicalTrials.gov Identifier: NCT00896792|
Recruitment Status : Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : November 17, 2017
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 or disease||Intervention/treatment||Phase|
|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||Not Applicable|
- To assess the effect of the palliative advanced registered nurse practitioner liaison program (PAL) on length of patient's enrollment in hospice care.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Actual Study Start Date :||October 2008|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
- Increased length of enrollment time in hospice care
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896792
|United States, Florida|
|Mayo Clinic in Jacksonville|
|Jacksonville, Florida, United States, 32224|
|Study Chair:||Gerardo Colon-Otero, M.D.||Mayo Clinic|