Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART

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).

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.