Opioids Titration in Hospice Patients

NCT01007422 | Withdrawn DMC

• 4 other identifiers: VICC SUPP 0822P30CA068485VU-VICC-SUPP-0822VU-VICC-IRB-IRB-080370
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Opioids lessen pain caused by cancer. Titration of opioids in the hospice setting is suboptimal due to numerous barriers. Order sets may help to provide timely and effective medical and pharmaceutical intervention. PURPOSE: The purpose of this study was to identify barriers to good pain control in the hospice setting and to develop an order set that would safely address these barriers.

Conditions

Pain; Solid Tumor

Keywords

unspecified adult solid tumor, protocol specific; pain

Outcome Measures

Primary Outcomes (1)

• To obtain determine the safety and feasibility of an opioid titration order sheet in the hospice setting.

  Pain assessments will be completed at baseline and daily for 4 weeks. Survey instruments will be completed at the end of weeks 1, 2, and 3.

  at 4 weeks

Study Arms (1)

Supportive Care

Behavioral: telephone-based intervention; Other: communication intervention; Other: intervention by caregiver; Other: medical chart review; Other: survey administration; Procedure: end-of-life treatment/management; Procedure: pain therapy; Procedure: psychosocial assessment and care

Interventions

telephone-based intervention BEHAVIORAL

Supportive Care

communication intervention OTHER

Supportive Care

intervention by caregiver OTHER

Supportive Care

medical chart review OTHER

Supportive Care

survey administration OTHER

Supportive Care

end-of-life treatment/management PROCEDURE

Supportive Care

pain therapy PROCEDURE

Supportive Care

psychosocial assessment and care PROCEDURE

Supportive Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Out-patient hospice patients.

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Outpatient at the Alive Hospice in the State of Tennessee * Diagnosed with carcinoma * Pain requiring fixed-dose opioids * Caregiver for an Alive Hospice patient * Any caregiver who is identified by the patient is eligible PATIENT CHARACTERISTICS: * Not pregnant or nursing * Able to speak/comprehend English * Lives within a 60-mile radius of Alive Hospice 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

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Pain

Interventions

Therapeutics; Analgesia; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Barbara A. Murphy, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 4, 2009
• Study Start: June 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 2, 2013

Record last verified: 2013-03