Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283166
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2006-01-25
Brief Title:
Coaching to Improve Care of Cancer Pain
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Coaching to Improve Care of Cancer Pain
Status:
COMPLETED
Status Verified Date:
2017-06
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:
An estimate of 90 of patients with cancer experience at least moderate pain at some point in their illness and 42 of patients do not receive adequate palliation The main objective of this research is to reduce barriers to pain control by creating more effective partnerships between patients and their health care providers The aims of the study are 1 to compare the effects on pain cancer-related symptoms and health-related quality of life of a standard cancer pain leaflet versus face-to-face tailored education and coaching 2 to estimate the effect of tailored education and coaching on patients self confidence for managing their pain and participating actively in care and 3 to examine the mechanisms underlying the beneficial effects of the intervention The proposed model will enhance research on pain management in that it is a pilot-tested intervention that is applicable in the outpatient setting based on Social Cognitive Theory and focused on patient activation and education
Detailed Description:
Background A small randomized trial was conducted in 2001 that supplied preliminary evidence that a carefully structured one-time individualized education and coaching intervention has the potential to provide important clinical benefits for patients suffering from cancer-related pain The study did not explore the impact of the intervention in a larger more diverse patient population the duration of the interventions benefits or the pathway by which the benefits are achieved This project will attempt to address these issues while building on the literature that exists in palliation and physician-patient communication
ObjectiveHypothesis The main objective of this research is to reduce barriers to pain control by creating more effective partnerships between patients and their health care providers
Specific Aims The aims of this study are 1 to compare the effects on pain cancer-related symptoms and health-related quality of life of a standard educational intervention versus face-to-face tailored education and coaching 2 to estimate the effect of tailored education and coaching on self-efficacy for pain self-management and for participation in care and 3 to examine the mechanisms underlying the beneficial effects of the intervention
Study Design The proposed study is a randomized controlled trial comparing education only with tailored education and coaching for patient activation TEC Eligible patients scheduled to see their oncologist at any of the three participating health systems will be invited to participate in the study Consenting patients will be randomly allocated to TEC or education only The intervention will be applied during a brief session just before the scheduled oncology visit Allocation will be concealed from physicians interviewers and data analysts Patients assigned to the usual care group will review the content of a standard informational booklet on cancer pain A health educator will review key learning points and be available to answer questions Patients assigned to the TEC group will receive an intervention designed to improve self-efficacy for both pain self-management and participation in care Data will be collected from patients in a private waiting alcove just prior to the index visit personal interview during the index visit audio-taping and then two six and 12 weeks after the visit phone interview In addition to assessing effectiveness of the intervention the study is designed to measure potential mediators and intermediate outcomes attitudes beliefs self-efficacy patient participation quality of care and adherence and to examine the mechanisms underlying the interventions beneficial effects The study will contribute to a test of Social Cognitive Theory by examining whether the benefit of the intervention is more powerfully attenuated by changes in attitudes and beliefs or by changes in self-efficacy
Cancer Relevance Uncontrolled cancer pain remains prevalent An estimated 90 of patients with cancer experience at least moderate pain at some point in their illness and 42 of patients do not receive adequate palliation Aside from impairing quality of life uncontrolled pain can contribute to depression increase the likelihood of suicide and decrease patient acceptance of potentially beneficial therapy The proposed project is valuable in that it will confirm the benefit of patient coaching elucidate its mechanisms and test Social Cognitive Theory The proposed model will enlarge existing research on pain management in that it is a 1 pilot tested easily implementable intervention that is 2 applicable in the outpatient setting 3 based on strong theory that makes predictions about mechanisms of benefit and 4 focused on patient activation as well as education
ObjectiveHypothesis The main objective of this research is to reduce barriers to pain control by creating more effective partnerships between patients and their health care providers
Specific Aims The aims of this study are 1 to compare the effects on pain cancer-related symptoms and health-related quality of life of a standard educational intervention versus face-to-face tailored education and coaching 2 to estimate the effect of tailored education and coaching on self-efficacy for pain self-management and for participation in care and 3 to examine the mechanisms underlying the beneficial effects of the intervention
Study Design The proposed study is a randomized controlled trial comparing education only with tailored education and coaching for patient activation TEC Eligible patients scheduled to see their oncologist at any of the three participating health systems will be invited to participate in the study Consenting patients will be randomly allocated to TEC or education only The intervention will be applied during a brief session just before the scheduled oncology visit Allocation will be concealed from physicians interviewers and data analysts Patients assigned to the usual care group will review the content of a standard informational booklet on cancer pain A health educator will review key learning points and be available to answer questions Patients assigned to the TEC group will receive an intervention designed to improve self-efficacy for both pain self-management and participation in care Data will be collected from patients in a private waiting alcove just prior to the index visit personal interview during the index visit audio-taping and then two six and 12 weeks after the visit phone interview In addition to assessing effectiveness of the intervention the study is designed to measure potential mediators and intermediate outcomes attitudes beliefs self-efficacy patient participation quality of care and adherence and to examine the mechanisms underlying the interventions beneficial effects The study will contribute to a test of Social Cognitive Theory by examining whether the benefit of the intervention is more powerfully attenuated by changes in attitudes and beliefs or by changes in self-efficacy
Cancer Relevance Uncontrolled cancer pain remains prevalent An estimated 90 of patients with cancer experience at least moderate pain at some point in their illness and 42 of patients do not receive adequate palliation Aside from impairing quality of life uncontrolled pain can contribute to depression increase the likelihood of suicide and decrease patient acceptance of potentially beneficial therapy The proposed project is valuable in that it will confirm the benefit of patient coaching elucidate its mechanisms and test Social Cognitive Theory The proposed model will enlarge existing research on pain management in that it is a 1 pilot tested easily implementable intervention that is 2 applicable in the outpatient setting 3 based on strong theory that makes predictions about mechanisms of benefit and 4 focused on patient activation as well as education
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 |
|---|---|---|---|
| ACS-KRPC-0609 | OTHER | UC Davis | None |
| RSGPB-06-091-01-CPPB | None | None | None |