NCT03468881

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

February 20, 2018

Last Update Submit

October 3, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 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 Outcomes (5)

  • 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

Study Arms (1)

Breast cancer radiation therapy

Observation over a period of all treatment sessions for radiotherapy.

Other: Communication Skills Training Package (KEW)

Interventions

Communication Skills Training Package (KEW)OTHER

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

Breast cancer radiation therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NHS Lothian Edinburgh Cancer Centre

Edinburgh, EH4 2XU, United Kingdom

RECRUITING

University of St Andrews

St Andrews, KY16 9TF, United Kingdom

NOT YET RECRUITING

Related Publications (9)

  • 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.

    PMID: 15333231BACKGROUND

  • 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.

    PMID: 15528286BACKGROUND

  • 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.

    PMID: 11978716BACKGROUND

  • 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. doi: 10.1136/jnnp.69.1.67.

    PMID: 10864606BACKGROUND

  • 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. doi: 10.1007/s11136-004-7713-0.

    PMID: 16110932BACKGROUND

  • 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.

    PMID: 29471823BACKGROUND

  • 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.

    PMID: 29455898RESULT

  • 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.

    PMID: 33692727DERIVED

  • 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.

    PMID: 30237899DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Gerald Humphris, PhD

    University of St Andrews

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Josie Cameron

CONTACT

07794334579josie.cameron@nhslothian.scot.nhs

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Health Psychology

Study Record Dates

First Submitted

February 20, 2018

First Posted

March 19, 2018

Study Start

September 1, 2018

Primary Completion

January 1, 2020

Study Completion

February 1, 2020

Last Updated

October 5, 2018

Record last verified: 2018-10

Locations

GB(2)