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Process and Outcomes of Pain Management

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00028249
First received: December 17, 2001
Last updated: March 3, 2008
Last verified: December 2005
  Purpose

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.


Condition
Pain
Neoplasm

Study Type: Observational
Official Title: A Randomized Study Evaluating the Process and Outcomes of the Pain and Palliative Care Team Intervention

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 298
Study Start Date: December 2001
Estimated Study Completion Date: December 2005
Detailed Description:

Pain is multidimensional. It is more than simply a physiologic or sensory response. Pain management programs are best developed by selecting interventions based on the individual's pain experience. Strategies with several mechanisms of action that complement each other might be selected to work together, thereby maximizing pain relief. The goal of palliative care is to achieve the highest possible quality of life for patients and their families through symptom control and attention to the whole patient, where physical, psychosocial, emotional, and spiritual dimensions are addressed. Provision of relief from pain and distressing symptoms is best served by a specialized interdisciplinary team with a comprehensive approach. The continuity of care for the patient and family is supported by communication and a strong partnership with the primary biomedical research team and the palliative care team.

Despite a number of descriptive studies exploring the effectiveness of specialized pain and palliative care teams, the paucity of good evaluations, with any comparative design, urgently needs to be addressed. This is a randomized, repeated measures, evaluation study to explore the effectiveness of the inpatient Pain and Palliative Care Service intervention. The data collected during this study will not only include outcomes of the intervention, but also patient and family perceptions of the care delivery process including issues surrounding communication with health care providers. Patients with advanced malignancies who are currently participating in NCI Surgery Branch protocols will be asked to participate in a pain and symptoms management evaluation study. Each patient and a designated family member will be asked to complete a series of questionnaires over time exploring physical, psychosocial and emotional correlates of pain and symptom management. Data will be analyzed using multivariate statistics.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

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.

Inclusion criteria are stated in the parent protocols.

Although each patient will be asked to identify a family member/significant other to participate in the study, patients will be eligible for inclusion regardless of whether they identify a family member for participation in the family questionnaires.

EXCLUSION CRITERIA:

All exclusions are stated in the NCI Surgery Branch parent protocols.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028249

Locations
United States, Maryland
National Institutes of Health Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00028249     History of Changes
Other Study ID Numbers: 020053, 02-CC-0053
Study First Received: December 17, 2001
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Patient Satisfaction
Self Efficacy
Social Support
Symptom Management
Advanced Malignancies
Pain Intervention

ClinicalTrials.gov processed this record on November 25, 2014