Clinical trial NCT03468881: A Communication Skills Package to Prevent Fear of Cancer Recurrence
Official title: Development and Feasibility of a Communication Training Package for Therapeutic Radiographers to Manage Emotional Talk With Breast Cancer Patients in Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: University of St Andrews
Sponsor class: OTHER
Collaborators: name: NHS Lothian
name: Breast Cancer Now
First posted: 2018-03-19
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: To evaluate the co-designed communication training package, 74 breast cancer patients receiving radiotherapy at the Edinburgh Cancer Centre will be recruited.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Fear of Recurrence level - FCR7
timeFrame: 6-8 weeks after treatment
Secondary outcomes:
measure: Fear of Recurrence level - FCR3
timeFrame: up to 4 weeks from baseline visit
measure: Positive And Negative Affect Schedule (PANAS)
timeFrame: 4 weeks following baseline visit
measure: Consultation and Relational Empathy measure (CARE)
timeFrame: 4 weeks following baseline visit
measure: An adaptation of the Medical Interview Satisfaction Scale (MISS-21)
timeFrame: 4 weeks following baseline visit
measure: 5 EQ-5D-3L
timeFrame: 6-8 weeks after treatment
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian Edinburgh Cancer Centre
city: St Andrews
country: United Kingdom
facility: University of St Andrews
Study officials:
affiliation: University of St Andrews
name: Gerald Humphris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crawford JR, Henry JD. The positive and negative affect schedule (PANAS): construct validity, measurement properties and normative data in a large non-clinical sample. Br J Clin Psychol. 2004 Sep;43(Pt 3):245-65. doi: 10.1348/0144665031752934.
citation: Mercer SW, Maxwell M, Heaney D, Watt GC. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Fam Pract. 2004 Dec;21(6):699-705. doi: 10.1093/fampra/cmh621. Epub 2004 Nov 4.
citation: Meakin R, Weinman J. The 'Medical Interview Satisfaction Scale' (MISS-21) adapted for British general practice. Fam Pract. 2002 Jun;19(3):257-63. doi: 10.1093/fampra/19.3.257.
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citation: Humphris GM, Watson E, Sharpe M, Ozakinci G. Unidimensional scales for fears of cancer recurrence and their psychometric properties: the FCR4 and FCR7. Health Qual Life Outcomes. 2018 Feb 9;16(1):30. doi: 10.1186/s12955-018-0850-x.
citation: Barracliffe L, Yang Y, Cameron J, Bedi C, Humphris G. Does emotional talk vary with fears of cancer recurrence trajectory? A content analysis of interactions between women with breast cancer and their therapeutic radiographers. J Psychosom Res. 2018 Mar;106:41-48. doi: 10.1016/j.jpsychores.2018.01.004. Epub 2018 Jan 9.
citation: van Beusekom M, Cameron J, Bedi C, Banks E, Harris R, Humphris G. Using Co-design With Breast Cancer Patients and Radiographers to Develop "KEW" Communication Skills Training. Front Psychol. 2021 Feb 22;12:629122. doi: 10.3389/fpsyg.2021.629122. eCollection 2021.
citation: van Beusekom M, Cameron J, Bedi C, Banks E, Kelsey T, Humphris G. Development, acceptability and feasibility of a communication skills training package for therapeutic radiographers to reduce fear of recurrence development in breast cancer patients (FORECAST2). Pilot Feasibility Stud. 2018 Sep 18;4:148. doi: 10.1186/s40814-018-0338-9. eCollection 2018.