Fear of Cancer Recurrence (FoR) Trajectory During Radiation Treatment

NCT ID: NCT02599506

Last Updated: 2018-10-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 97 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2016-10-31

Brief 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. 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

breast cancer radiation therapy

Observation over a period of all treatment sessions for radiotherapy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Female patient 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

University of St Andrews

OTHER

Sponsor Role: lead

Responsible Party

Prof G Humphris

Professor of Health Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerald M Humphris, PhD

Role: PRINCIPAL_INVESTIGATOR

University of St Andrews

Locations

NHS Lothian Edinburgh Cancer Centre

Edinburgh, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 15333231 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10864606 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16110932 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30626327 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30342495 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30276473 (View on PubMed)

Other Identifiers

20l5MaySP529

Identifier Type: -

Identifier Source: org_study_id