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Optimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART.
Kelleher, Sarah A; Dorfman, Caroline S; Plumb Vilardaga, Jen C; Majestic, Catherine; Winger, Joseph; Gandhi, Vicky; Nunez, Christine; Van Denburg, Alyssa; Shelby, Rebecca A; Reed, Shelby D; Murphy, Susan; Davidian, Marie; Laber, Eric B; Kimmick, Gretchen G; Westbrook, Kelly W; Abernethy, Amy P; Somers, Tamara J.
Afiliação
  • Kelleher SA; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
  • Dorfman CS; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
  • Plumb Vilardaga JC; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
  • Majestic C; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
  • Winger J; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
  • Gandhi V; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
  • Nunez C; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
  • Van Denburg A; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
  • Shelby RA; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
  • Reed SD; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, United States.
  • Murphy S; Department of Statistics, University of Michigan, Ann Arbor, MI, United States.
  • Davidian M; Department of Statistics, North Carolina State University, Raleigh, NC, United States.
  • Laber EB; Department of Statistics, North Carolina State University, Raleigh, NC, United States.
  • Kimmick GG; Department of Internal Medicine, Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States.
  • Westbrook KW; Department of Internal Medicine, Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States.
  • Abernethy AP; Division of Medical Oncology, Duke University Medical Center, Durham, NC, United States.
  • Somers TJ; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States. Electronic address: tamara.somers@duke.edu.
Contemp Clin Trials ; 57: 51-57, 2017 06.
Article em En | MEDLINE | ID: mdl-28408335
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 (ratings≥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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias da Mama / Terapia Cognitivo-Comportamental / Manejo da Dor Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Female / Humans Idioma: En Ano de publicação: 2017 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias da Mama / Terapia Cognitivo-Comportamental / Manejo da Dor Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Female / Humans Idioma: En Ano de publicação: 2017 Tipo de documento: Article