Breast Cancer Clinical Trial
Official title:
Development and Feasibility of a Communication Training Package for Therapeutic Radiographers to Manage Emotional Talk With Breast Cancer Patients in Treatment
This study (FORECAST 2) builds upon the work of the successful pilot study (FORECAST) that found some evidence that breast cancer patients' fears of cancer recurrence (FCR) were sensitive to the communication exchange with therapeutic radiographers during weekly review appointments. The aim of FORECAST 2 is to co-design and pilot a communication training package for therapeutic radiographers to help them manage emotional talk with breast cancer patients who are undergoing treatment, with the intention to minimise patients' development of FCR during this trajectory.
The first aim of this study is to develop a training package (called KEW: Know, Encourage and
Warm-up) to enhance communication skills of therapeutic radiographers in responding to
emotions and concerns that are expressed by breast cancer patients at weekly review
appointments. The first two phases of the project address this aim. Phase 1 will use a
co-design methodology in which patients and therapeutic radiographers come together to
develop a storyboard for the video and manual that will comprise the training package. Both
local and national patient representatives and radiographers will be asked to comment and
provide feedback on the output of the co-design process, leading to the production of the
training video and manual (phase 2). Data collection will include verbatim transcripts from
the co-design process, which will be content analysed to identify recommended techniques to
be used within the review radiotherapy setting.
Phase 3 of the project addresses the second study aim, which is to pilot the package in a
single service to test the acceptability into routine practice, to collect details for the
preparation of a RCT study that includes more service units, to produce an electronic diary
assessment of recurrence fears and to observe practice benefits within service. A pilot
workshop will be conducted, after which 74 (female) breast cancer patients will be recruited
to participate. All measures required for the RCT will be included.
Patients will complete questions including: 1) demographic information, 2) a 7-item FCR scale
(FCR7) and 3) a 20-item Affect Schedule (PANAS) before first radiation treatment (T1).
Throughout the period of treatment, patients will be asked to fill in a daily 3-item FCR
questionnaire (FCR3) either in the form of a paper dairy or through a mobile phone
application to monitor their FCR level. Then, at the end of the radiotherapy treatment (T2),
PANAS and FCR7 will be measured again. Patients will also be asked to complete an adaptation
of the Medical Interview Satisfaction Sale (MISS) and the Consultation and Relational Empathy
measure (CARE). Finally, six-eight weeks after the end of the treatment (T3), all
participants will be asked to complete the FCR7 once again as well as a 5-item EuroQoL
EQ-5D-3L scale by telephone.
The same system of latent variable growth curve analysis as in the pilot FORECAST study will
be used to calculate patients' FCR trajectory and link these to FCR7 outcomes. With a sample
size of 74 patients, a medium to low-sized effect of 0.375 at 80% power and alpha (2-sided)
set to 0.05 can be detected to demonstrate if the KEW intervention can decrease levels of FCR
compared to the FCR levels obtained in the FORECAST pilot study.
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