Sarah A Kelleher1, Caroline S Dorfman1, Jen C Plumb Vilardaga1, Catherine Majestic1, Joseph Winger1, Vicky Gandhi1, Christine Nunez1, Alyssa Van Denburg1, Rebecca A Shelby1, Shelby D Reed2, Susan Murphy3, Marie Davidian4, Eric B Laber4, Gretchen G Kimmick5, Kelly W Westbrook5, Amy P Abernethy6, Tamara J Somers7. 1. Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States. 2. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, United States. 3. Department of Statistics, University of Michigan, Ann Arbor, MI, United States. 4. Department of Statistics, North Carolina State University, Raleigh, NC, United States. 5. Department of Internal Medicine, Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States. 6. Division of Medical Oncology, Duke University Medical Center, Durham, NC, United States. 7. Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States. Electronic address: tamara.somers@duke.edu.
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 (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.
RCT Entities:
BACKGROUND/AIMS: Pain is common in cancerpatients 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 cancerpatients (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 cancerpatients and in chronic illness; if successful, it could serve as a model for future work with a wide range of chronic illnesses.
Authors: Shelby D Reed; Yanhong Li; Shital Kamble; Daniel Polsky; Felicia L Graham; Margaret T Bowers; Gregory P Samsa; Sara Paul; Kevin A Schulman; David J Whellan; Barbara J Riegel Journal: Circ Cardiovasc Qual Outcomes Date: 2011-12-06
Authors: Robert H Dworkin; Dennis C Turk; Ethan Basch; Ann Berger; Charles Cleeland; John T Farrar; Jennifer A Haythornthwaite; Mark P Jensen; Robert D Kerns; John Markman; Linda Porter; Srinivasa N Raja; Edgar Ross; Knox Todd; Mark Wallace; Clifford J Woolf Journal: Pain Date: 2011-03-10 Impact factor: 6.961
Authors: A M Jette; A R Davies; P D Cleary; D R Calkins; L V Rubenstein; A Fink; J Kosecoff; R T Young; R H Brook; T L Delbanco Journal: J Gen Intern Med Date: 1986 May-Jun Impact factor: 5.128
Authors: Tari D Topolski; James LoGerfo; Donald L Patrick; Barbara Williams; Julie Walwick; Marsha B Patrick Journal: Prev Chronic Dis Date: 2006-09-15 Impact factor: 2.830
Authors: Cari Berget; Kimberly A Driscoll; Ann Lagges; Samantha Lange; Linda A DiMeglio; Tamara S Hannon; Stephanie E Woerner; Esti Iturralde; Regan C Barley; Sarah Hanes; Korey K Hood; Bruce B Buckingham Journal: Contemp Clin Trials Date: 2019-05-23 Impact factor: 2.226
Authors: Melissa L Erickson; Jacob M Allen; Daniel P Beavers; Linda M Collins; Karina W Davidson; Kirk I Erickson; Karyn A Esser; Matthijs K C Hesselink; Kerrie L Moreau; Eric B Laber; Charlotte A Peterson; Courtney M Peterson; Jane E Reusch; John P Thyfault; Shawn D Youngstedt; Juleen R Zierath; Bret H Goodpaster; Nathan K LeBrasseur; Thomas W Buford; Lauren M Sparks Journal: Geroscience Date: 2022-10-15 Impact factor: 7.581
Authors: Jennifer C Plumb Vilardaga; Hannah M Fisher; Joseph G Winger; Shannon N Miller; Christine Nuñez; Catherine Majestic; Sarah A Kelleher; Tamara J Somers Journal: Support Care Cancer Date: 2022-05-02 Impact factor: 3.359
Authors: Joseph G Winger; Sarah A Kelleher; Hannah M Fisher; Tamara J Somers; Gregory P Samsa Journal: J Pain Symptom Manage Date: 2022-02-27 Impact factor: 5.576
Authors: Hannah M Fisher; Juliann Stalls; Joseph G Winger; Shannon N Miller; Jennifer C Plumb Vilardaga; Catherine Majestic; Sarah A Kelleher; Tamara J Somers Journal: J Psychosoc Oncol Date: 2022-03-21
Authors: Sarah A Kelleher; Joseph G Winger; Hannah M Fisher; Shannon N Miller; Shelby D Reed; Beverly E Thorn; Bonnie Spring; Gregory P Samsa; Catherine M Majestic; Rebecca A Shelby; Linda M Sutton; Francis J Keefe; Tamara J Somers Journal: Contemp Clin Trials Date: 2021-01-23 Impact factor: 2.261
Authors: Hannah M Fisher; Joseph G Winger; Shannon N Miller; Arianna N Wright; Jennifer C Plumb Vilardaga; Catherine Majestic; Sarah A Kelleher; Tamara J Somers Journal: Support Care Cancer Date: 2021-03-15 Impact factor: 3.603