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Journal of Complementary and Integrative Medicine

Editor-in-Chief: Lui, Edmund

Ed. by Ko, Robert / Leung, Kelvin Sze-Yin / Saunders, Paul / Suntres, PH. D., Zacharias

CiteScore 2017: 1.41

SCImago Journal Rank (SJR) 2017: 0.472
Source Normalized Impact per Paper (SNIP) 2017: 0.564

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Model structure for protocol adherence utilizing a manualized therapeutic massage intervention

Erika R. Larson / Becky Kinkead
  • Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA
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/ Sherry A. Edwards
  • Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA
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/ Pamela J. Schettler
  • Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA
  • Depatrtment of Psychiatry, University of California San Diego School of Medicine, San Diego, CA, USA
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/ Boadie W. Dunlop
  • Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA
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/ Jeffrey J. Rakofsky
  • Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA
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/ Mark H. Rapaport
  • Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA
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Published Online: 2018-10-12 | DOI: https://doi.org/10.1515/jcim-2016-0118



The Protocol Training and Assessment Model (Model) was developed through collaboration between Emory University School of Medicine and Atlanta School of Massage to minimize intra- and inter-therapist variability for two research massage therapist (rMT) applied intervention arms in the Massage for Cancer-Related Fatigue (MCRF) early-phase study. The Model was followed to maintain and assess protocol integrity for the study’s manualized Swedish massage therapy (SMT) and light touch (LT) interventions.


The Model includes initial rMT training, quarterly retraining sessions, accessible resources (scripts, treatment guides, weekly research personnel meetings), and ongoing monitoring. Model efficacy was assessed by monitoring data collected at retraining sessions, through audio recording review, and through subject and rMT reporting.


Model application resulted in a high level of intervention consistency throughout the study. Protocol-related session comment rate by subjects was 2.7%. Few study participants reported intra-rMT or inter-rMT treatment delivery differences. Observation during retraining sessions indicated massage therapists continued to adhere to protocols. Importantly rMTs increased their participation beyond core duties, suggesting additional ways to standardize subject treatment experience.


Through systematic application of the Protocol Training and Assessment Model, continuous and collaborative quality improvement discussions between scientists and research massage therapists resulted in reliable, standardized SMT and LT interventions for the MCRF early-phase study. Future research can apply the Model to support and assess consistent rMT-delivered intervention applications.

This article offers supplementary material which is provided at the end of the article.

Keywords: collaboration; fidelity; protocol; therapeutic massage; training model


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About the article

Received: 2016-10-14

Accepted: 2018-07-12

Published Online: 2018-10-12

Authors’ contribution: ERL data analysis, manuscript preparation, and revisions; BK revisions; SAE clinical coordinator and data collection; PJS study statistician and revisions; BWD & JJR study physicians; MHR principal investigator, study design, study physician, and revisions

Research funding: This study is funded through grant R21AT007090 from National Center for Complementary & Integrative Health and the National Cancer Institute.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

Citation Information: Journal of Complementary and Integrative Medicine, 20160118, ISSN (Online) 1553-3840, DOI: https://doi.org/10.1515/jcim-2016-0118.

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