ANAHEIM, CALIFORNIA—Intervention fidelity is an essential element of randomized, clinical trials. To illustrate this point, one researcher described how intervention fidelity was incorporated into her clinical trial evaluating self-administration of acupressure for persistent cancer-related fatigue in breast cancer.

The National Institutes of Health Behavior Change Consortium Workgroup identified five elements of intervention fidelity: study design, training, delivery, receipt, and enactment. During a podium session at the Oncology Nursing Society (ONS) 39th Annual Congress, Dawn Frambes, RN, BSN, MSA, of Michigan State University College of Nursing, outlined her team’s research and discussed how intervention fidelity was incorporated into their trial.

In the ongoing trial, instructors taught breast cancer survivors to self-administer acupressure to relieve persistent cancer-related fatigue. The researchers randomly assigned participants to three groups: one that performs relaxation acupressure, a second that performs stimulating acupressure, and a third was a control group. There are five data collection points including a screening visit, a baseline visit during which they are taught to perform acupressure if they have been assigned to an intervention group, and then three more follow-up visits that occur approximately 3 weeks apart.

In terms of intervention fidelity, dose parameters are an important element of design. Three components need to be considered: number of sessions in this study, duration of the sessions, and interval between sessions. In this study, the researchers asked women to perform acupressure sequences once per day at any time within the 24-hour period.

Training is another component of intervention fidelity. In this study, training has two levels, according to Frambes, which are important to study design. Multiple trainers received training on performing acupressure who then in turn trained the study participants.

The training for this particular study involves identifying points on the body and demonstrating how to activate that pressure point. Once the trainer is able to demonstrate that he or she can perform and instruct another person to perform acupressure, then the instructors work with participants at each of their sites on performing either the relaxation or stimulation acupressure technique. A one-on-one demonstration is performed, and all participants receive a video demonstration that they are able to take home.

Intervention fidelity also involves monitoring the consistent delivery of the intervention as defined by the study protocol. Frambes said that for their study, the instructor observes the participant’s technique approximately 3 weeks after training to determine competency and accuracy of the intervention. This also allows them to provide refinement and correction of technique if necessary. The goal is to achieve 95% accuracy with their performance, she said.

Another aspect of intervention fidelity is receipt, according to Frambes, which deals with whether the person is actually getting the intervention when it is supposed to be done. For this study, the researchers are looking at whether participants are performing acupressure daily as recorded in a log administered during the training session.

The trial is still in process, but the researchers do have some measures of receipt. At week 3, Frambes said, the women who were randomly assigned to relaxation acupressure were doing 91% of sessions and those assigned to stimulating acupressure were doing 95% of possible sessions. At 6 weeks, these numbers were 92% for the relaxation group and 97% for the stimulating group.

Enactment, another component of intervention fidelity, addresses the long-term effects, which can be very difficult to monitor in studies because of funding or a lack of resources. Although this study yields some data on long-term effects at 10 weeks, 12 months or more would be ideal.

“The implications for this particular type of research component are that, when you have studies and know that the protocols address intervention fidelity and then these protocols are monitored through the course of study, you know that the results have a fairly good level of internal and external validity, and hopefully can be translated to real-world settings,” Frambes said.

Frambes noted that, when their study on acupressure for persistent cancer-related fatigue in breast cancer is complete, she hopes the results will add to the body of evidence and provide more background on how important intervention fidelity is in this type of work.

Frambes suggested that clinicians “should consider recommending interventions that have incorporated fidelity methods in their efficacy testing so that they can be confident that the intervention will or will not work because of the protocol followed.”

REFERENCE

Frambes D. Intervention Fidelity: Acupressure for Persistent Cancer-Related Fatigue. Presented at: Oncology Nursing Society (ONS) 39th Annual Congress; May 1-4, 2014; Anaheim, CA.