Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART
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About
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).
Full 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).
Enrollment
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
327 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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