A Communication Skills Package to Prevent Fear of Cancer Recurrence

Breast Cancer Clinical Trial

— FORECAST2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03468881
• Other study ID #: 2017MayPR898
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: February 2020

Study information

• Verified date: October 2018
• Source: University of St Andrews
• Contact: Josie Cameron
• Phone: 07794334579
• Email: josie.cameron[@]nhslothian.scot.nhs
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: February 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Communication Skills Training Package (KEW)
A training package (called KEW: Know, Encourage and Warm-up) for therapeutic radiographers to manage emotional talk with breast cancer patients in treatment.

Locations

Country	Name	City	State
United Kingdom	NHS Lothian Edinburgh Cancer Centre	Edinburgh
United Kingdom	University of St Andrews	St Andrews

Sponsors (3)

Lead Sponsor	Collaborator
University of St Andrews	Breast Cancer Now, NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

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;1 — View 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. — View 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. — View 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. — View 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. Epub 2004 Nov 4. — View Citation

Schrag A, Selai C, Jahanshahi M, Quinn NP. The EQ-5D--a generic quality of life measure-is a useful instrument to measure quality of life in patients with Parkinson's disease. J Neurol Neurosurg Psychiatry. 2000 Jul;69(1):67-73. — View Citation

Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005 Aug;14(6):1523-32. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fear of Recurrence level - FCR7	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 a of 0.92) and its construct validity has been demonstrated through association with the Hospital Anxiety and Depression Scale (HADS) (Humphris et al., 2018).	6-8 weeks after treatment
Secondary	Fear of Recurrence level - FCR3	The Fear of Recurrence level scale (FCR3) is a 3-item self-report measure of patients' fear of cancer recurrence. It has been used previously in the FORECAST pilot study and is based on the 4-item scale FCR4, which psychometric qualities are supportive of its internal consistency (Cronbach's a of 0.92) and validity (association with the Hospital Anxiety and Depression Scale (HADS)) (Humphris et al., 2018).	up to 4 weeks from baseline visit
Secondary	Positive And Negative Affect Schedule (PANAS)	The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report measure of positive and negative affect. The PANAS has been shown to possess adequate psychometric properties in a large sample drawn from the general adult population, and the construct validity of the PANAS scales and the reliabilities of both scales were adequate, Cronbach's a were 0.89 for Positive Affectivity and 0.85 for Negative Affectivity (Crawford & Henry, 2004).	4 weeks following baseline visit
Secondary	Consultation and Relational Empathy measure (CARE)	The Consultation and Relational Empathy measure (CARE) is a 10-item self-report measure of patients' experience of clinical encounters. It shows high internal reliability (Cronbach's a of 0.92) and sufficient evidence of face validity (feedback from 10 patients) and convergent validity (r = 0.85 versus Reynolds Empathy Measure (RES)) (Mercer et al., 2004).	4 weeks following baseline visit
Secondary	An adaptation of the Medical Interview Satisfaction Scale (MISS-21)	The Medical Interview Satisfaction Scale (MISS-21) is a 21-item self-report measure of patients' satisfaction with doctor consultations, validated in British general practice populations. Internal consistency scores ranges between Cronbach's a of 0.67 and 0.92 for the four subscales. There is sufficient evidence construct validity of the MISS-21 with highly significant positive correlations (0.21-0.63) between MISS-21 scores and aspects of satisfaction with previous consultations (Meakin & Weinman, 2002). The FORECAST 2 study will make use of selected questions from MISS-21 that are relevant to the clinical encounters with therapeutic radiographers.	4 weeks following baseline visit
Secondary	5 EQ-5D-3L	The EQ-5D-3L is a standardised instrument for use as a measure of health outcome and was developed by the EuroQol Research foundation. It consists of five questions relating to five dimensions of health; mobility, self-care, usual activities, pain and discomfort and anxiety and depression. The EQ-5D has well-established validity and reliability and has been used in many studies of patients with a variety of chronic conditions in many different countries (Schrag et al., 2000; Walters & Brazier, 2005).	6-8 weeks after treatment