Ignite Creation Date:
2024-05-06 @ 8:41 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02791646
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2016-06-02
Brief Title:
Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART
Status:
COMPLETED
Status Verified Date:
2023-08
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:
SMART
Brief Summary:
This trial is a sequential multiple assignment randomized trial SMART that will examine response to differing doses of a behavioral cancer pain intervention Pain Coping Skills Training PCST and subsequent response-based adjustments to doses Cancer patients with pain will initially be randomized to receive either PCST-Full or PCST-Brief Participants who do not report pain reduction to their initially assigned intervention will be re-randomized to receive either maintenance or an increased level of intervention Participants who report pain reduction to their initially assigned intervention will be re-randomized to either a maintenance dose or no further treatment Intervention responses will be compared across conditions using a standard two-sided two-sample t-test Techniques typically used for SMART studies will be used to compare intervention dosage sequences across PCTS that adjusts to initial dosage based on patient responses The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention eg loss of confidentiality
Detailed Description:
The incidence of moderate to severe pain in cancer patients remains greater than 50 NIH guidelines recommend the implementation of behavioral cancer pain interventions into patient care Yet implementation remains low Evidence on patient dose-response ie number of sessions skills intervention adaption based on initial response and understanding personal characteristics related to differing dose-response can improve implementation by optimizing behavioral intervention delivery
This trial is a sequential multiple assignment randomized trial SMART that will examine response to differing doses of a behavioral cancer pain intervention Pain Coping Skills Training PCST and subsequent response-based adjustments to doses Cancer patients with pain N327 will initially be randomized to receive either PCST-Full or PCST-Brief Participants who do not respond 30 pain reduction to their initially assigned intervention will be re-randomized to receive either maintenance ie booster sessions focused on problem solving and skills reinforcement or an increased level of intervention ie additional sessions and skills Participants who respond 30 pain reduction to their initially assigned intervention will be re-randomized to either a maintenance dose or no further treatment Intervention responses will be reduction in pain will be compared across conditions using a standard two-sided two-sample t-test Techniques typically used for SMART studies will be used to compare intervention dosage sequences across PCTS that adjusts to initial dosage based on patient responses The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention eg loss of confidentiality
This trial is a sequential multiple assignment randomized trial SMART that will examine response to differing doses of a behavioral cancer pain intervention Pain Coping Skills Training PCST and subsequent response-based adjustments to doses Cancer patients with pain N327 will initially be randomized to receive either PCST-Full or PCST-Brief Participants who do not respond 30 pain reduction to their initially assigned intervention will be re-randomized to receive either maintenance ie booster sessions focused on problem solving and skills reinforcement or an increased level of intervention ie additional sessions and skills Participants who respond 30 pain reduction to their initially assigned intervention will be re-randomized to either a maintenance dose or no further treatment Intervention responses will be reduction in pain will be compared across conditions using a standard two-sided two-sample t-test Techniques typically used for SMART studies will be used to compare intervention dosage sequences across PCTS that adjusts to initial dosage based on patient responses The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention eg loss of confidentiality
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