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Breast CancerFORECASTNCT02599506

Fear of Cancer Recurrence (FoR) Trajectory During Radiation Treatment

An observational study of Breast Cancer, run by University of St Andrews at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot study concentrates on studying the trajectory of breast cancer patient's fear of recurrence (FoR) over the course of radiation therapy. The aim is to collect repeated ratings of 100 breast cancer patient's FoR over the course of their treatment. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
How many people
97 participants
Where
1 siteUnited Kingdom
Study dates
1 Dec 2015to 31 Oct 2016
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: In this study, 100 breast cancer patients receiving radiotherapy at the Edinburgh Cancer Centre will be recruited.

Who may be able to join

  • Female patient 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

1 site in 1 country.

United Kingdom1 site

  • NHS Lothian Edinburgh Cancer Centre

    Edinburgh, EH4 2XU

Other trials in United Kingdom

About this study

Official title: Fear of Cancer Recurrence (FoR) Trajectory During Radiation Treatment and Follow-up Into Survivorship of 100 Breast Cancer patients-a Pilot Study

This pilot study concentrates on studying the trajectory of breast cancer patient's fear of recurrence (FoR) over the course of radiation therapy. The aim is to collect repeated ratings of 100 breast cancer patient's FoR over the course of their treatment. It is hypothesized that cancer patient's FoR level will rise on nearing the termination of the in radiotherapy treatment, and radiotherapist-patient interaction modifies the development of patient's FoR.

Read the detailed description

The aim of this pilot study is to examine the collection of FoR levels in a longitudinal design with 100 breast cancer patients receiving radiotherapy for their disease. In this study, an intensive longitudinal design will be employed (Bolger \& Laurenceau, 2013). There will be two data collection types. First, will be self-reported questionnaires. Patients will complete questions including three sections: 1) demographic information (i.e. age, education, employment, marital/family status), 2) a 7-item FoR scale (ACCRE FCR) and 3) a 20-item Affect Schedule (PANAS) before first radiation treatment (T1). Throughout the period of treatment, a 3-item FoR questionnaire (ACCRE FCR 3 Items) will be designed as a daily diary to monitor patient's FoR level. Then, at the end of the radiotherapy treatment (T2), PANAS will be measured again. Finally, six-eight weeks after the end of the treatment (T3), all participants will be asked to complete the 7-items FCR questionnaire once again as well as a 5-item EuroQoL EQ-5D-3L scale by telephone.

The second data collection media is audiotape. The conversations between radiotherapist and patient in the weekly review appointment will be recorded and a behavioural coding system (VR-CoDES) will be used to analyse the interactions between patient and radiotherapist.

Data analysis will involve statistical analysis and qualitative methods. Statistical analyses will be conducted using Statistical Package for the Social Sciences (SPSS) Analytics software v.22, Analysis of MOment Structures (AMOS) v.22 and MPlus™ (SEM: Structural Equation Modelling). Initial analysis will plot individual and group average curves over the days that patients are treated. The analysis will develop a statistical model based upon SEM principles of growth curves. Each patient is expected to disclose increased fears of recurrence over the course of treatment. Latent curve modelling will be developed to test the relationship of FoR over the time course of the treatment.

As part of this pilot study the investigators wish to investigate the appropriateness of these models and to test the extent of growth of FoR to the outcome at 6-8 weeks follow up, using the FoR 7 item measure. Covariates will be introduced for control purposes and indicate initial level of negative affectivity (The Positive and Negative Affect Schedule - PANAS), age and initial level of disease severity. Alternative strategies of analysis are considered appropriate and may enable a parallel strategy. This would involve a simpler approach concentrating on the raw data. Linear modelling (multi-level) which will include estimation of linear slopes being used to predict FoR outcome.

Audio recordings of the consultation will be transcribed verbatim in order to investigate how the radiotherapist-patient communication affects the development of FoR.

Conditions
Breast Cancer
Keywords
breast cancer, fear of recurrence, longitudinal study, radiation therapy, emotional concerns, trajectory, psychological constructs, diary keeping
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02599506
Study groupRoleWhat they receive
breast cancer radiation therapyObservation over a period of all treatment sessions for radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fear of Recurrence Level-ACCRE FCR

    The ACCRE FCR scale has been employed in a national study, it ranges from 4-20. A score of 10 is a significant level (60th percentile) considered appropriate for the patient to receive a brief intervention.

    Measured: 6-8 weeks after treatment

Secondary outcomes (2)

  1. The 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

  2. 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.

  1. First posted6 Nov 2015 (estimated)
  2. Study start1 Dec 2015
  3. Primary completion1 Jun 2016
  4. Study completion31 Oct 2016

Resources

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
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02599506
Sponsor's protocol ID
20l5MaySP529
Acronym
FORECAST
Status last verified
Sep 2018
First submitted
3 Nov 2015
Last updated
1 Oct 2018
Results posted
No
Data monitoring committee
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 15333231

  • 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.

    PubMed 10864606

  • 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.

    PubMed 16110932

  • Popov V, Ellis-Robinson A, Humphris G. Modelling reassurances of clinicians with hidden Markov models. BMC Med Res Methodol. 2019 Jan 9;19(1):11. doi: 10.1186/s12874-018-0629-0.

    PubMed 30626327

  • Yang Y, Cameron J, Bedi C, Humphris G. Fear of cancer recurrence trajectory during radiation treatment and follow-up into survivorship of patients with breast cancer. BMC Cancer. 2018 Oct 20;18(1):1002. doi: 10.1186/s12885-018-4908-2.

    PubMed 30342495

  • Humphris G, Yang Y, Barracliffe L, Cameron J, Bedi C. Emotional talk of patients with breast cancer during review appointments with therapeutic radiographers: effects on fears of cancer recurrence. Support Care Cancer. 2019 Jun;27(6):2143-2151. doi: 10.1007/s00520-018-4484-7. Epub 2018 Oct 1.

    PubMed 30276473

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by University of St Andrews at 1 site 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: finished, as of the sponsor's last update on 1 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 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fear of Recurrence Level-ACCRE FCR (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 NCT02599506, which also lists 6 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 1 Oct 2018.

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