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临床试验/NCT03468881
NCT03468881Unknown不适用

Development and Feasibility of a Communication Training Package for Therapeutic Radiographers to Manage Emotional Talk With Breast Cancer Patients in Treatment

University of St Andrews2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
74
试验地点
2
主要终点
Fear of Recurrence level - FCR7

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients who are diagnosed with breast cancer, age 18+

排除标准

  • Under 18 years old
  • Known psychiatric illness
  • Receiving palliative radiotherapy (non-curative)
  • Unable to communicate in English

结局指标

主要结局

Fear of Recurrence level - FCR7

时间窗: 6-8 weeks after treatment

The Fear of Recurrence level scale (FCR7) is a 7-item self-report measure of patients' fear of cancer recurrence. It has been used previously in a national study and the FORECAST pilot. It shows high internal consistency (Cronbach's α of 0.92) and its construct validity has been demonstrated through association with the Hospital Anxiety and Depression Scale (HADS) (Humphris et al., 2018).

次要结局

  • Fear of Recurrence level - FCR3(up to 4 weeks from baseline visit)
  • Positive And Negative Affect Schedule (PANAS)(4 weeks following baseline visit)
  • Consultation and Relational Empathy measure (CARE)(4 weeks following baseline visit)
  • An adaptation of the Medical Interview Satisfaction Scale (MISS-21)(4 weeks following baseline visit)
  • 5 EQ-5D-3L(6-8 weeks after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof G Humphris

Chair of Health Psychology

University of St Andrews

研究点 (2)

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A Communication Skills Package to Prevent Fear of... | 临床试验