Clinical trial · Interventional
Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCST-Brief | — | UNRESOLVED | — |
| PCST-Full (Pain Coping Skills Training) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pain Coping Skills Brief | Behavioral | — | UNRESOLVED |
| Pain Coping Skills Training Full | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PCST-Full
- description
- PCST-full will consist of a 5-session intervention delivered to participants at the medical center by their therapist.
- interventionNames
- Behavioral: Pain Coping Skills Training Full
- type
- EXPERIMENTAL
- label
- PCST-Brief
- description
- Pain coping skills training brief (PCST-Brief) will consist of a 60 minute, in-person session followed by 4-weeks of daily text messaging
- interventionNames
- Behavioral: Pain Coping Skills Brief
Primary outcomes (2)
- measure
- Change in Pain intensity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDLi Y, Reed SD, Winger JG, Hyland KA, Fisher HM, Kelleher SA, Miller SN, Davidian M, Laber EB, Keefe FJ, Somers TJ. Cost-Effectiveness Analysis Evaluating Delivery Strategies for Pain Coping Skills Training in Women With Breast Cancer. J Pain. 2023 Sep;24(9):1712-1720. doi: 10.1016/j.jpain.2023.05.004. Epub 2023 May 13. PMID 37187219
- DERIVEDKelleher 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. PMID 28408335