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Licensed Unlicensed Requires Authentication Published by De Gruyter October 12, 2018

Model structure for protocol adherence utilizing a manualized therapeutic massage intervention

  • Erika R. Larson EMAIL logo , Becky Kinkead , Sherry A. Edwards , Pamela J. Schettler , Boadie W. Dunlop , Jeffrey J. Rakofsky and Mark H. Rapaport



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.

List of Non-Standard Abbreviations


National Center for Complementary and Integrative Health


Atlanta School of Massage


Swedish massage therapy


light touch


research massage therapist


Protocol Training and Assessment Model


cancer-related fatigue


Massage for Cancer-related Fatigue

Emory BHC

Emory University’s School of Medicine Brain Health Center


waitlist control


Emory University Institutional Review Board


standard operating procedures

1 rMT

one research massage therapist

>1 rMT

more than one research massage therapist


This study was conducted via the partnership between Emory University School of Medicine and the Atlanta School of Massage. The authors wish to acknowledge the rMTs of MCRF: Shanese Armstrong-Mark, Dedric Carroll, Melissa Comer, Sarah Istambouli, Suzanne Ledoux, Grace Prior, and Brittney Turner; and Atlanta School of Massage staff: Leticia Allen, Maggie Alfieri, Aaron Gunn, and Lovelace Linares.

  1. 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

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

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. 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.


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Supplementary Material

The online version of this article offers supplementary material (DOI:

Received: 2016-10-14
Accepted: 2018-07-12
Published Online: 2018-10-12

© 2019 Walter de Gruyter GmbH, Berlin/Boston

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