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

Publication ,  Journal Article
Kelleher, SA; Dorfman, CS; Plumb Vilardaga, JC; Majestic, C; Winger, J; Gandhi, V; Nunez, C; Van Denburg, A; Shelby, RA; Reed, SD; Murphy, S ...
Published in: Contemp Clin Trials
June 2017

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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Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

June 2017

Volume

57

Start / End Page

51 / 57

Location

United States

Related Subject Headings

  • Public Health
  • Pain Measurement
  • Pain Management
  • Humans
  • General Clinical Medicine
  • Female
  • Cost-Benefit Analysis
  • Cognitive Behavioral Therapy
  • Breast Neoplasms
  • Adult
 

Citation

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Kelleher, S. A., Dorfman, C. S., Plumb Vilardaga, J. C., Majestic, C., Winger, J., Gandhi, V., … Somers, T. J. (2017). Optimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART. Contemp Clin Trials, 57, 51–57. https://doi.org/10.1016/j.cct.2017.04.001
Kelleher, Sarah A., Caroline S. Dorfman, Jen C. Plumb Vilardaga, Catherine Majestic, Joseph Winger, Vicky Gandhi, Christine Nunez, et al. “Optimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART.Contemp Clin Trials 57 (June 2017): 51–57. https://doi.org/10.1016/j.cct.2017.04.001.
Kelleher SA, Dorfman CS, Plumb Vilardaga JC, Majestic C, Winger J, Gandhi V, et al. Optimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART. Contemp Clin Trials. 2017 Jun;57:51–7.
Kelleher, Sarah A., et al. “Optimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART.Contemp Clin Trials, vol. 57, June 2017, pp. 51–57. Pubmed, doi:10.1016/j.cct.2017.04.001.
Kelleher 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.
Journal cover image

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

June 2017

Volume

57

Start / End Page

51 / 57

Location

United States

Related Subject Headings

  • Public Health
  • Pain Measurement
  • Pain Management
  • Humans
  • General Clinical Medicine
  • Female
  • Cost-Benefit Analysis
  • Cognitive Behavioral Therapy
  • Breast Neoplasms
  • Adult