Breast CancerFORECAST2NCT03468881
A Communication Skills Package to Prevent Fear of Cancer Recurrence
An observational study of Breast Cancer, run by University of St Andrews at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Communication Skills Training Package (KEW)
- How many people
- 74 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Sep 2018to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: To evaluate the co-designed communication training package, 74 breast cancer patients receiving radiotherapy at the Edinburgh Cancer Centre will be recruited.
Who may be able to join
- Female patients who are diagnosed with breast cancer, age 18+
Who cannot join
- Under 18 years old
- Male
- Known psychiatric illness
- Receiving palliative radiotherapy (non-curative)
- Unable to communicate in English
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
NHS Lothian Edinburgh Cancer Centre
Edinburgh, EH4 2XU
Gerald Humphris, PhD, 01334463565, gmh4@st-andrews.ac.uk
Gerald Humphris, PhD
- Not yet recruiting
University of St Andrews
St Andrews, KY16 9TF
Tom Kelsey, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Communication Skills Training Package (KEW)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer radiation therapy | Observation over a period of all treatment sessions for radiotherapy. Receives: Other: Communication Skills Training Package (KEW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6-8 weeks after treatment
Secondary outcomes (5)
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 α of 0.92) and validity (association with the Hospital Anxiety and Depression Scale (HADS)) (Humphris et al., 2018).
Measured: up to 4 weeks from baseline visit
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 α were 0.89 for Positive Affectivity and 0.85 for Negative Affectivity (Crawford \& Henry, 2004).
Measured: 4 weeks following baseline visit
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 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).
Measured: 4 weeks following baseline visit
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 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.
Measured: 4 weeks following baseline visit
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).
Measured: 6-8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 Sep 2018
- Primary completionJan 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of St Andrews
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian, Breast Cancer Now
- Responsible party
- Principal investigator, Prof G Humphris, University of St Andrews
- Investigators
- Gerald Humphris, PhD, Principal investigator, University of St Andrews
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468881
- Sponsor's protocol ID
- 2017MayPR898
- Acronym
- FORECAST2
- Status last verified
- Oct 2018
- First submitted
- 20 Feb 2018
- Last updated
- 5 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 15333231Mercer 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.
PubMed 15528286Meakin 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.
PubMed 11978716Schrag 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.
PubMed 10864606Walters 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.
PubMed 16110932Humphris 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.
PubMed 29471823Barracliffe 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.
PubMed 29455898van 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.
PubMed 33692727van 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.
PubMed 30237899
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility of a Communication Training Package for Therapeutic Radiographers to Manage Emotional Talk With Breast Cancer Patients in Treatment
- ClinicalTrials.gov ID
- NCT03468881
- Acronym / sponsor ID
- FORECAST2 / 2017MayPR898
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of St AndrewsUniversity, hospital or other
- Collaborators
- NHS Lothian, Breast Cancer Now
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer radiation therapy | – | Other: Communication Skills Training Package (KEW)Observation over a period of all treatment sessions for radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To evaluate the co-designed communication training package, 74 breast cancer patients receiving radiotherapy at the Edinburgh Cancer Centre will be recruited.
Key inclusion criteria (1 listed)
- Female patients who are diagnosed with breast cancer, age 18+
Key exclusion criteria (5 listed)
- Under 18 years old
- Male
- Known psychiatric illness
- Receiving palliative radiotherapy (non-curative)
- Unable to communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Breast cancer radiation therapy |
Primary outcome
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).
5 secondary outcomes
Fear of Recurrence level - FCR3
Time frame: up to 4 weeks from baseline visit
Positive And Negative Affect Schedule (PANAS)
Time frame: 4 weeks following baseline visit
Consultation and Relational Empathy measure (CARE)
Time frame: 4 weeks following baseline visit
An adaptation of the Medical Interview Satisfaction Scale (MISS-21)
Time frame: 4 weeks following baseline visit
5 EQ-5D-3L
Time frame: 6-8 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Background: PubMed 15333231Crawford 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.
- Background: PubMed 15528286Mercer 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.
- Background: PubMed 11978716Meakin 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.
- Background: PubMed 10864606Schrag 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.
- Background: PubMed 16110932Walters 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.
- Background: PubMed 29471823Humphris 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.
- Results publication: PubMed 29455898Barracliffe 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.
- Derived from this study: PubMed 33692727van 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.
- Derived from this study: PubMed 30237899van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Humphris, PhD principal investigator
University of St Andrews
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of St Andrews at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josie Cameron (07794334579, josie.cameron@nhslothian.scot.nhs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Recurrence level - FCR7 (time frame: 6-8 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03468881, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.