A Communication Skills Package to Prevent Fear of Cancer Recurrence (FORECAST2)

October 3, 2018 updated by: Prof G Humphris, University of St Andrews

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Recruiting
        • NHS Lothian Edinburgh Cancer Centre
        • Contact:
        • Principal Investigator:
          • Gerald Humphris, PhD
        • Sub-Investigator:
          • Josie Cameron
        • Sub-Investigator:
          • Carolyn Bedi, PhD
        • Sub-Investigator:
          • Mara van Beusekom, PhD
      • St Andrews, United Kingdom, KY16 9TF
        • Not yet recruiting
        • University of St Andrews
        • Contact:
          • Tom Kelsey, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast cancer radiation therapy
Observation over a period of all treatment sessions for radiotherapy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of Recurrence level - FCR7
Time Frame: 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).
6-8 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5 EQ-5D-3L
Time Frame: 6-8 weeks after treatment
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
Fear of Recurrence level - FCR3
Time Frame: up to 4 weeks from baseline visit
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 α 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
Positive And Negative Affect Schedule (PANAS)
Time Frame: 4 weeks following baseline visit
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 α were 0.89 for Positive Affectivity and 0.85 for Negative Affectivity (Crawford & Henry, 2004).
4 weeks following baseline visit
Consultation and Relational Empathy measure (CARE)
Time Frame: 4 weeks following baseline visit
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 α 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
An adaptation of the Medical Interview Satisfaction Scale (MISS-21)
Time Frame: 4 weeks following baseline visit
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 α 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of St Andrews

Collaborators

NHS Lothian
Breast Cancer Now

Investigators

  • Principal Investigator: Gerald Humphris, PhD, University of St Andrews

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

October 5, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017MayPR898

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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