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. 2022 May 16;12(5):e059952. doi: 10.1136/bmjopen-2021-059952

Table 2.

Intervention fidelity strategies

Study design
Study design procedures have been designed to ensure tha the study can adequately test its hypotheses in relation to underlying theory and clinical practices.
Training providers Standardised provider training includes procedures to ensure that interventionists have been satisfactorily trained to deliver the intervention to cancer survivor participants. This training will involve:
  • Provision of a study manual to all staff which includes:

    • Generic study-related information: study overview, reporting/documentation guidelines, communication flowchart, rationale for the study treatment, self-management goal setting, motivational interviewing and health coaching.

    • Intervener-specific information: job description, intervention protocol, quality assurance and monitoring

  • The trained registered nurse responsible for the intervention will have approximately 4 hours of pre-reading modules developed by the chief investigators, and approximately 4 hours of practical training. This will include:

    • Clinical management of CRF

    • NCCN CRF guidelines

    • Exercise and physical activity advice

    • Provision of self-management support (including collaborative goal setting and motivational interviewing, sleep hygiene and energy conservation)

    • Education about referral pathways for services within Princess Alexandra Hospital referral flow charts and contact details for community services

  • The data collector will have necessary prereading and training. This will include:

    • Data collection tools and procedures to be used

    • NCCN CRF guidelines for the screening and assessment of CRF

Delivery of treatment Intervention procedures will be monitored to improve delivery of intervention and comparison of conditions, and ensure that the intervention is delivered as intended, through:
  • The nurse-led clinics will be audio and/ or video recorded and checked for quality assurance.

  • The intervention fidelity will be closely monitored and discussed during the monthly meeting for the first 3 months of the trial between the intervention nurses, intervention physiotherapist, research assistants and/or chief investigators.

  • Omissions and/or protocol deviations will be reviewed on an individual basis.

  • Intervention checklist completed at the end of each intervention to allow protocol deviation tracking across interveners and conditions.

  • Minimising contamination between conditions by training interventionists to address cancer survivor participant questions about randomisation and their assigned condition using non-biased explanations.

Receipt of treatment Treatment receipt focuses on the cancer survivor participant and includes procedures to assure that the treatment was both received and understood. This goal will be achieved by:
  • Ensuring participants understand the information provided for each intervention, by checking through use of active questions and behavioural observations

Enactment of treatment skills Enactment of treatment skills includes processes to monitor and improve cancer survivor participant ability to perform treatment-related behavioural skills and cognitive strategies in relevant real-life settings as intended. This goal will be achieved by:
  • ensuring participants are aware of the follow-up schedules and responsibilities of all health professionals.

  • ensuring participants will have a copy of the completed self-management care plan including all care responsibilities and goals set for the individual

CRF, cancer-related fatigue; NCCN, National Comprehensive Cancer Network.