Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574009
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Better Options for Chronic Cancer Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Better Options for Chronic Cancer Pain a SMART Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This proposal is relevant to the 240000 cancer survivors who continue to use opioids long after they have successfully completed treatment for cancer at the VHA placing them at risk of opioid addiction and overdose and other opioid-related problems Yet there are no programs at the VHA to help them find alternatives to opioids nor evidence to inform the choice of interventions This study will meet these needs by examining four interventions that are effective at reducing opioid use in patients with chronic musculoskeletal pain but have yet to be tested in cancer survivors on long term opioid therapy The proposed work is relevant to the VHA Pain Offices mission to provide Veterans better pain management while limiting the risks of long-term opioid therapy and it aligns with VHA Research and Developments priority to examine clinical interventions for tapering opioids Successful completion this project will keep VHA at the forefront of the battle against the opioid epidemic with a strategy that may be adapted to address the same needs in non-Veterans
Detailed Description:
Background Twenty-four percent of Veterans who survive cancer remain on long term opioid therapy LTOT after completing cancer treatment placing them at significant risk of opioid addiction overdose and other opioid-related health conditions To reduce opioid use in this population the investigators will examine the impacts of multimodal pain care and buprenorphine rotation - two strategies that have demonstrated efficacy in Veterans with musculoskeletal pain on LTOT but have not been tested in cancer survivors on LTOT revealing a critical knowledge gap The overall scientific premise of this project is that these two approaches can effectively reduce LTOT in cancer survivors without worsening chronic pain and that they are better than pain medication optimization and opioid tapering The primary objective is to examine which treatment strategy or combination of strategies is most successful at achieving a reduction in LTOT without worsening chronic pain over 6 and 9 months The investigators will also identify the key challenges and strategies in the implementation of each treatment strategy to facilitate future translation of study findings into VA practice
Significance There are currently no care pathways at the VHA to help cancer survivors on LTOT find alternatives to opioids for managing chronic pain nor evidence to guide which interventions to include By addressing these unmet needs this work aligns with POU-AMPs priority to examine clinical interventions for tapering opioid medications
Innovation The investigators are among the first to examine multimodal care and buprenorphine rotation to reduce LTOT in cancer survivors Also the investigators are among the first to apply VHAs evidence-based stepped care model of multidisciplinary pain care to cancer survivors on LTOT
Aim 1 To test if Veterans who receive multimodal pain care will be more likely to decrease total daily opioid use by at least 20 at 6 and 9 months without experiencing worsened pain interference compared to those who receive optimization of non-opioid pain medications
Aim 2 To test if Veterans who do not respond to 6 months of multimodal care or medication optimization are more likely to achieve the desired outcome at 9 months when they are offered buprenorphine rotation as opposed to opioid tapering
Exploratory Aim 3 To examine which combination of interventions is most likely to achieve the desired outcome at 9 months
Aim 4 To understand the key challenges and strategies in the implementation of each intervention to facilitate future translation of study findings into practice
Methodology The investigators plan a two-site two-stage response-adaptive comparative effectiveness trial following SMART Sequential Multiple-Assignment Randomized Trial principles The investigators will enroll 294 Veteran cancer survivors on LTOT who receive their care at the Indianapolis or Ann Arbor VAMC Subjects will be randomized to either multimodal pain care or pain medication optimization at Stage 1 After 6 months non-respondents will be randomized to buprenorphine rotation or opioid tapering in Stage 2 The primary outcome is a composite variable combining one objective outcome opioid dose reduction and one subjective outcome pain interference assessed at 6 and 9 months The secondary outcomes are opioid dose reduction and pain interference individually
Next StepsImplementation Successful execution of this project will provide actionable information including an implementation strategy that VHAs Offices of Pain Management and Oncology can put in place to support over 240000 cancer survivors on LTOT for chronic pain
Significance There are currently no care pathways at the VHA to help cancer survivors on LTOT find alternatives to opioids for managing chronic pain nor evidence to guide which interventions to include By addressing these unmet needs this work aligns with POU-AMPs priority to examine clinical interventions for tapering opioid medications
Innovation The investigators are among the first to examine multimodal care and buprenorphine rotation to reduce LTOT in cancer survivors Also the investigators are among the first to apply VHAs evidence-based stepped care model of multidisciplinary pain care to cancer survivors on LTOT
Aim 1 To test if Veterans who receive multimodal pain care will be more likely to decrease total daily opioid use by at least 20 at 6 and 9 months without experiencing worsened pain interference compared to those who receive optimization of non-opioid pain medications
Aim 2 To test if Veterans who do not respond to 6 months of multimodal care or medication optimization are more likely to achieve the desired outcome at 9 months when they are offered buprenorphine rotation as opposed to opioid tapering
Exploratory Aim 3 To examine which combination of interventions is most likely to achieve the desired outcome at 9 months
Aim 4 To understand the key challenges and strategies in the implementation of each intervention to facilitate future translation of study findings into practice
Methodology The investigators plan a two-site two-stage response-adaptive comparative effectiveness trial following SMART Sequential Multiple-Assignment Randomized Trial principles The investigators will enroll 294 Veteran cancer survivors on LTOT who receive their care at the Indianapolis or Ann Arbor VAMC Subjects will be randomized to either multimodal pain care or pain medication optimization at Stage 1 After 6 months non-respondents will be randomized to buprenorphine rotation or opioid tapering in Stage 2 The primary outcome is a composite variable combining one objective outcome opioid dose reduction and one subjective outcome pain interference assessed at 6 and 9 months The secondary outcomes are opioid dose reduction and pain interference individually
Next StepsImplementation Successful execution of this project will provide actionable information including an implementation strategy that VHAs Offices of Pain Management and Oncology can put in place to support over 240000 cancer survivors on LTOT for chronic pain
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