Optimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART.

TitleOptimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART.
Publication TypeJournal Article
Year of Publication2017
AuthorsKelleher, Sarah A., Caroline S. Dorfman, Jen C. Plumb Vilardaga, Catherine Majestic, Joseph Winger, Vicky Gandhi, Christine Nunez, Alyssa Van Denburg, Rebecca A. Shelby, Shelby D. Reed, Susan Murphy, Marie Davidian, Eric B. Laber, Gretchen G. Kimmick, Kelly W. Westbrook, Amy P. Abernethy, and Tamara J. Somers
JournalContemp Clin Trials
Volume57
Pagination51-57
Date Published2017 06
ISSN1559-2030
KeywordsAdaptation, Psychological, Adult, Breast Neoplasms, Cognitive Behavioral Therapy, Cost-Benefit Analysis, Female, Humans, Pain Management, Pain Measurement
Abstract

BACKGROUND/AIMS: Pain is common in cancer patients and results in lower quality of life, depression, poor physical functioning, financial difficulty, and decreased survival time. Behavioral pain interventions are effective and nonpharmacologic. Traditional randomized controlled trials (RCT) test interventions of fixed time and dose, which poorly represent successive treatment decisions in clinical practice. We utilize a novel approach to conduct a RCT, the sequential multiple assignment randomized trial (SMART) design, to provide comparative evidence of: 1) response to differing initial doses of a pain coping skills training (PCST) intervention and 2) intervention dose sequences adjusted based on patient response. We also examine: 3) participant characteristics moderating intervention responses and 4) cost-effectiveness and practicality.METHODS/DESIGN: Breast cancer patients (N=327) having pain (ratingsā‰„5) are recruited and randomly assigned to: 1) PCST-Full or 2) PCST-Brief. PCST-Full consists of 5 PCST sessions. PCST-Brief consists of one 60-min PCST session. Five weeks post-randomization, participants re-rate their pain and are re-randomized, based on intervention response, to receive additional PCST sessions, maintenance calls, or no further intervention. Participants complete measures of pain intensity, interference and catastrophizing.CONCLUSIONS: Novel RCT designs may provide information that can be used to optimize behavioral pain interventions to be adaptive, better meet patients' needs, reduce barriers, and match with clinical practice. This is one of the first trials to use a novel design to evaluate symptom management in cancer patients and in chronic illness; if successful, it could serve as a model for future work with a wide range of chronic illnesses.

DOI10.1016/j.cct.2017.04.001
Alternate JournalContemp Clin Trials
Original PublicationOptimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART.
PubMed ID28408335
PubMed Central IDPMC5681223
Grant ListP01 CA142538 / CA / NCI NIH HHS / United States
R01 CA202779 / CA / NCI NIH HHS / United States