Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028249
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-12-17
Brief Title:
Process and Outcomes of Pain Management
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Study Evaluating the Process and Outcomes of the Pain and Palliative Care Team Intervention
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Centers 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 patients permission the interviews will be tape recorded
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 Centers 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 patients permission the interviews will be tape recorded
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 individuals 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-CC-0053 | None | None | None |