Clinical trial NCT02791646: Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART
Official title: Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PCST-Full (Pain Coping Skills Training)
PCST-Brief
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 327
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (e.g., 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 (i.e., 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 (N=327) 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 (i.e., booster sessions focused on problem solving and skills reinforcement) or an increased level of intervention (i.e., 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 (e.g., loss of confidentiality).

Eligibility criteria: Inclusion Criteria:

* diagnosis of breast cancer (initial or recurrence) within the last two years
* being \>18 years old
* having a life expectancy of at least 12 months
* having a pain intensity rating of \>5.

Exclusion Criteria:

* cognitive impairment
* metastases to the brain
* presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff
* current or past (\<6 months) engagement in PCST for cancer.

Primary outcomes:
measure: Change in Pain intensity
timeFrame: baseline to 6 weeks
measure: Change in Pain Intensity
timeFrame: Baseline, 6 weeks, 3 months and 6 months
Secondary outcomes:
measure: Pain Interference
timeFrame: Baseline, 6 weeks, 3 months and 6 months
measure: Practicality as measured by accrual
timeFrame: 8 months
measure: Practicality as measured by retention
timeFrame: 8 months
measure: Practicality as measured by adherence
timeFrame: 8 months
measure: Pain Catastrophizing, as measured by the 6-item pain catastrophizing subscale of the Coping Strategies Questionnaire
timeFrame: Baseline, 6 weeks, 3 months and 6 months
measure: Cost-Effectiveness
timeFrame: 8 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Tamara J Somers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kelleher SA, Dorfman CS, Plumb Vilardaga JC, Majestic C, Winger J, Gandhi V, Nunez C, Van Denburg A, Shelby RA, Reed SD, Murphy S, Davidian M, Laber EB, Kimmick GG, Westbrook KW, Abernethy AP, Somers TJ. Optimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART. Contemp Clin Trials. 2017 Jun;57:51-57. doi: 10.1016/j.cct.2017.04.001. Epub 2017 Apr 11.