This trial is active, not recruiting.

Conditions hematopoietic/lymphoid cancer, unspecified adult solid tumor, protocol specific
Treatments counseling intervention, questionnaire administration, survey administration, end-of-life treatment/management, psychosocial assessment and care
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date October 2008
End date September 2016
Trial size 100 participants
Trial identifier NCT00896792, 08-002293, CDR0000615562, MC0892, P30CA015083


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.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Increased length of enrollment time in hospice care
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.