NCT00028249

Brief Summary

This study will investigate the most effective approach for managing pain and providing palliative care (lessening of pain or symptoms). Patients with advanced cancer who are enrolled in a National Cancer Institute (NCI) protocol and will undergo major surgery as part of their treatment may be eligible for this study. Participants will be randomly assigned to pain management provided by either 1) their attending physician or 2) the Clinical Center's Pain and Palliative Care Service. Patients in the first group may be reassigned to the Pain and Palliative Care Service at any time during the study. Participants will be interviewed every 3 months for as long as 1 year about their pain, its effect on several areas of their lives, changes in their needs, and how well they think their pain is being managed.. As the patients progress through the NCI study, they will meet regularly and as often as needed with either their attending physician or the Pain and Palliative Care team. Each interview will last about 20 to 30 minutes. With the patient's permission, the interviews will be tape recorded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2001

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

December 1, 2005

First QC Date

December 17, 2001

Last Update Submit

March 3, 2008

Conditions

Keywords

Patient SatisfactionSelf EfficacySocial SupportSymptom ManagementAdvanced MalignanciesPain Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with advanced malignancies who are currently undergoing major surgical procedures in NCI Surgery Branch will be recruited to participate in a pain and symptoms management evaluation study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Higginson IJ. Evidence based palliative care. There is some evidence-and there needs to be more. BMJ. 1999 Aug 21;319(7208):462-3. doi: 10.1136/bmj.319.7208.462. No abstract available.

    PMID: 10454384BACKGROUND
  • Axelsson B, Christensen SB. Evaluation of a hospital-based palliative support service with particular regard to financial outcome measures. Palliat Med. 1998 Jan;12(1):41-9. doi: 10.1191/026921698671336362.

    PMID: 9616458BACKGROUND
  • Axelsson B, Sjoden PO. Quality of life of cancer patients and their spouses in palliative home care. Palliat Med. 1998 Jan;12(1):29-39. doi: 10.1191/026921698676629560.

    PMID: 9616457BACKGROUND

MeSH Terms

Conditions

PainNeoplasmsPatient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

December 17, 2001

First Posted

December 18, 2001

Study Start

December 1, 2001

Study Completion

December 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-12

Locations